List of Abbreviations
AD – autonomic dysreflexia
URUT – upper urinary tract; OAB – overactive bladder
DSD – detrusor-sphincter dyssynergia
UTI — urinary tract infection
ICD-10 – International Classification of Diseases, 10th Revision
BL – bladder
NDO – neurogenic detrusor overactivity
NLUTD – neurogenic lower urinary tract dysfunction
UI – urinary incontinence
LUT – lower urinary tract
NRSU – non-relaxing urethral sphincter
SCI – spinal cord injury
MS – multiple sclerosis
SUI – stress urinary incontinence
LUTS – lower urinary tract symptoms
US – ultrasound examination
UUI – urgency urinary incontinence
Terms and Definitions
Autonomic dysreflexia is a sudden and exaggerated response of the autonomic nervous system to various stimuli in patients with spinal cord injury or dysfunction at or above the T6 spinal segment. It is defined as an increase in systolic blood pressure of >20 mm Hg above baseline. Autonomic dysreflexia may present with symptoms (headache, blurred vision, nasal congestion, piloerection, facial flushing, increased sweating above the level of the lesion (vasodilation), paleness and cold skin (vasoconstriction) below the level of the lesion) or may be asymptomatic.
Aseptic intermittent catheterization is intermittent catheterization performed under sterile conditions. It involves disinfection of the genitalia and the use of sterile catheters, medical instruments, and gloves.
Overactive bladder (also known as urgency syndrome or frequency-urgency syndrome) is a syndrome characterized by urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence.
Bladder diary is the recording of time and volume of voids, episodes of urinary incontinence (UI), use of pads, as well as other information including fluid intake, degree of urgency, and urinary incontinence (UI).
Catheterization is the technique of emptying the urinary bladder or a urinary reservoir using a catheter.
Indwelling catheterization is the placement of an indwelling catheter that remains in the bladder, reservoir, or conduit for a period longer than a single drainage.
Urinary incontinence is any involuntary leakage of urine.
Neurogenic lower urinary tract dysfunction (NLUTD) is a lower urinary tract dysfunction developing secondary to a confirmed innervation disorder.
Intermittent catheterization is the drainage of the urinary bladder or urinary reservoir using a catheter followed by its immediate removal. It can be performed as "self-catheterization" when the procedure is carried out by the patient, or performed by another person (a physician, nurse, or relative).
Intermittent self-catheterization (self-catheterization) is catheterization of the urinary bladder performed by the patient themselves.
Stress urinary incontinence is the involuntary leakage of urine from the urethra upon physical exertion, sneezing, and/or coughing.
Urgency urinary incontinence is the involuntary leakage of urine from the urethra, accompanied by an urgent, compelling desire to void.
Clean intermittent catheterization is the performance of urinary bladder catheterization under "clean" conditions. It involves the use of single-use or reusable catheters.
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Neurogenic lower urinary tract dysfunction (NLUTD) encompasses storage and voiding disorders of the urinary bladder that develop secondary to a neurological disease [1, 2, 3].
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
NLUTD can be caused by various diseases and pathological conditions characterized by impaired neural regulation of the lower urinary tract (LUT). Any damage to the neural structures controlling LUT function can cause neurogenic dysfunction. The nature and clinical manifestations of NLUTD mainly depend on the localization and severity of the neurological impairment.
NLUTD may be complicated by the development of complications, the most dangerous of which is impaired renal function. Since symptom severity does not correlate with the likelihood of long-term complications [4], it is necessary to identify patients with neurogenic dysfunction and stratify them into risk groups for complications (high/low). The risk of upper urinary tract (UUT) damage and renal failure is much lower in patients with slowly progressive non-traumatic pathology than in patients with spinal cord injury or spina bifida [5]. Treatment tactics and monitoring schedules depend on the type of neurogenic dysfunction and its underlying cause.
1.3 Epidemiology of the Disease or Condition
To date, there are no exact data on the prevalence of NLUTD in the general population of the Russian Federation and other countries, but there are data on the incidence of neurological diseases and the relative risk of developing NLUTD secondary to them. It is important to note that most reported figures have a wide range of values due to cohort differences (early or late disease stage), small sample sizes, and low levels of evidence in most published studies (Appendix G3) [6–29, 30].
1.4 Features of Coding the Disease or Condition
Neuromuscular dysfunction of the bladder, not elsewhere classified (N31):
N31.0 – uninhibited neuropathic bladder, not elsewhere classified;
N31.1 – reflex neuropathic bladder, not elsewhere classified;
N31.2 – flaccid neuropathic bladder, not elsewhere classified;
N31.8 – other neuromuscular dysfunctions of bladder;
N31.9 – neuromuscular dysfunction of bladder, unspecified.
Other paralytic syndromes (G83) and Other disorders of spinal cord (G95):
G83.4 – cauda equina neurogenic bladder;
G95.8 – neurogenic bladder of spinal cord, due to spinal cord lesion.
1.5 Classification of the disease or condition
There is no universal classification applicable to all types of voiding disorders in neurological diseases due to the diversity of possible lesions in the motor and sensory innervation pathways of the organs involved in urination. From a practical standpoint, a classification based on the predominance of storage versus voiding symptoms, or various types of dynamic disorders such as detrusor-sphincter dyssynergia, is convenient.
The nature of lower urinary tract dysfunction in neurological diseases is determined by the localization and nature of the pathological lesions.
The Russian Society of Urology categorizes NLUTD according to the level of central nervous system lesions with characteristic urodynamic features [3]:
Suprapontine lesions with urodynamic signs of detrusor overactivity;
Spinal cord lesions with urodynamic signs of detrusor overactivity and/or detrusor-sphincter dyssynergia;
Sacral/infrasacral lesions with urodynamic signs of detrusor underactivity and/or detrusor acontractility [3].
1.6 Clinical presentation of the disease or condition
Complaints may include symptoms associated with the storage and/or emptying phases of the urinary bladder, such as urinary retention, difficulty urinating, or urinary incontinence. Storage and voiding symptoms in neurogenic LUT dysfunction are determined by the nature and localization of the nervous system lesion. Suprapontine lesions of the nervous system are typically characterized by storage symptoms; spinal cord lesions are characterized by both storage and voiding symptoms; and sacral/infrasacral lesions are characterized by voiding symptoms. In patients with cognitive impairment, complaints must be correlated with objective examination findings.
2. Diagnostics, medical indications and contraindications for diagnostic methods
Criteria for establishing the diagnosis/condition based on pathognomonic findings
For neurogenic stress urinary incontinence:
History of urinary incontinence episodes associated with physical exertion, coughing, sneezing, walking, changing body position, or other conditions leading to increased intra-abdominal pressure.
History of a neurological disease that may be the pathogenetic cause of urinary incontinence.
Physical examination: presence of a positive cough test.
Instrumental examination: absence of post-void residual urine on bladder ultrasound.
For neurogenic urgency urinary incontinence:
History of urinary incontinence episodes associated with an imperative desire to urinate, sometimes accompanied by pollakiuria and nocturia.
History of a neurological disease that may be the pathogenetic cause of urgency urinary incontinence.
Physical examination: presence of a negative cough test.
Instrumental examination: absence of post-void residual urine on bladder ultrasound.
Complex urodynamic study: detrusor overactivity in the bladder filling phase.
For neurogenic mixed urinary incontinence:
History of urinary incontinence episodes associated with an imperative desire to urinate, sometimes accompanied by pollakiuria and nocturia, combined with a history of urinary incontinence episodes associated with physical exertion, coughing, sneezing, walking, changing body position, or other conditions leading to increased intra-abdominal pressure.
History of a neurological disease that may be the pathogenetic cause of urinary incontinence and storage symptoms.
Physical examination: presence of a positive cough test.
Instrumental examination: absence of post-void residual urine on ultrasound.
For neurogenic dysfunctional voiding (detrusor-sphincter dyssynergia):
History of urinary incontinence episodes combined with chronic urinary retention.
History of a neurological disease that may be the pathogenetic cause of voiding dysfunction and storage symptoms.
Instrumental examination: presence of post-void residual urine on ultrasound.
Complex urodynamic study: presence of a bladder contraction during the emptying phase in the absence of urethral sphincter relaxation and a low flow rate / absence of urination.
For neurogenic chronic urinary retention:
History of chronic urinary retention.
History of a neurological disease that may be the pathogenetic cause of urinary retention.
Instrumental examination: presence of post-void residual urine on ultrasound.
Complex urodynamic study: absence of a coordinated bladder contraction during the emptying phase.
The main criterion for establishing the diagnosis of neurogenic lower urinary tract dysfunction (NLUTD) is the presence of lower urinary tract symptoms against the background of a neurological disorder. NLUTD also includes conditions where lower urinary tract symptoms are a consequence of pelvic organ disease treatment (multimodal treatment, radiation therapy, and surgical interventions) accompanied by pelvic nerve injury [25].
Urological storage and voiding symptoms may be the onset or the only manifestation of a neurological lesion. There are no other, more precise criteria for establishing the diagnosis of NLUTD [30].
In NLUTD, the diagnostic goal is to determine the type of dysfunction. A thorough medical history, physical examination, and bladder diaries are mandatory steps to be performed before planning any additional diagnostic methods for the patient. The results of the initial examination do not always allow determining long-term treatment and follow-up tactics, and require a more in-depth examination.
It is recommended to evaluate neurological status in all patients with NLUTD during diagnosis, as voiding disorders are secondary and do not always depend on the severity of the underlying neurological disease [31].
GCR CLOCE 4Grade of Recommendation C (Level of Evidence 4)
Comments: Early diagnosis and treatment are important in both congenital and acquired neurological diseases to prevent irreversible changes in the upper and lower urinary tracts.
2.1 Complaints and Anamnesis
It is recommended that all patients with suspected NLUTD, during the medical history taking, gather information on the onset of the neurological disease, the appearance of urological symptoms with an emphasis on previously existing symptoms, including urinary, bowel, and sexual function, as well as take into account the patient's previously noted and currently existing disease symptoms in order to develop the sequence and scope of diagnostic and therapeutic procedures (Appendix G4) [32, 33].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comments: In non-traumatic cases of NLUTD with a gradual onset and development of disorders, a detailed medical history allows determining the age period of symptom onset (childhood or adolescence). Urological symptoms associated with the storage and voiding phase may be the onset or the sole manifestation of a neurological lesion. The presence of bladder, bowel, and sexual function symptoms without neurological symptoms may indicate a neurological disease. Patients with sensory impairments, for example, in spinal cord injury, find it difficult to accurately describe the symptoms of voiding disorders [34].
It is recommended in all patients with suspected NLUTD to clarify the following to identify concomitant neurogenic bowel dysfunctions: frequency of bowel movements; fecal incontinence; urge to defecate; characteristics of defecation; rectal sensitivity [35].
GCR CLOE 4Grade of Recommendation C (Level of Evidence 4).
Comments: clusters of motor and sensory neurons regulating the function of the intestine and bladder are located at the same segmental spinal cord level, which explains the combined symptoms in these patients.
It is recommended for patients with suspected NLUTD at the diagnostic stage to maintain bladder diaries (determination of urine volume) (Appendix G2) to obtain objective information on the frequency of urination, volume of urine portions, number of absorbent pads used, presence of urinary incontinence episodes, and urgency [36].
GCR CLOCE 4Grade of Recommendation C (Level of Evidence 4)
Comments: Determining the frequency of urination and the severity of lower urinary tract symptoms is an important step in assessing and treating lower urinary tract dysfunction, including urinary incontinence. Bladder diaries are considered a method for quantitative assessment of symptoms, including the number of urinary incontinence episodes. They also make it possible to determine urodynamic parameters, for example, voiding volume, daily and nocturnal diuresis. When using intermittent catheterization, the diary must record the number of catheterizations performed during the day and the volume of urine excreted. The duration of maintaining bladder diaries is selected individually, but it is advisable to keep bladder diaries for 72 hours.
It is recommended when taking a medical history in all patients with suspected NLUTD to use questionnaires and scales for a subjective assessment of the condition of a patient suffering from urinary incontinence [37].
GGR BLEL 3Grade of Recommendation B (Level of Evidence 3)
Comments: Validated disease-specific symptom scales help in assessing the severity of symptoms, such as the intensity of urgency. Questionnaires assist in screening and differentiating types of urinary incontinence, and in standardized symptom assessment. In addition, they are used for the dynamic assessment of the patient's condition and treatment efficacy (Appendix G1).
2.2 Physical Examination
It is recommended in patients with NLUTD to perform genital palpation during physical examination (palpation in male genital pathology, bimanual pelvic examination) to verify the diagnosis, including assessment of reflexes in the urogenital zone, especially the bulbocavernosus reflex and anal reflex (palpation in peripheral nervous system pathology, examination of the sensory and motor spheres in peripheral nervous system pathology, palpation in central nervous system and brain pathology, examination of the sensory and motor spheres in central nervous system and brain pathology) [38].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comments: Physical examination includes determining sensitivity and reflexes mediated through the lower segments of the spinal cord. Deviations from the norm indicate a lesion at the level of the lumbosacral segments; topical diagnosis of various sensory disorders allows determining the localization of the pathological process. During perineal inspection, sensitivity at the S2–S5 segment level (on both sides) is assessed. Segmental involvement, presence of sensitivity (increased, normal, decreased, absent), and type of perception of blunt and sharp objects are evaluated. Reflexes (hyperactive, normal, hypoactive, absent) are described: bulbocavernosus reflex, anal reflex, knee and ankle reflexes, plantar reflexes, cremasteric reflexes.
It is recommended that men with neurogenic lower urinary tract dysfunction (NLUTD) undergo a digital rectal examination of the prostate, anal sphincter tone, and pelvic floor muscles, along with assessment of urogenital zone sensitivity and evaluation of the prostate and pelvic muscles (bimanual rectoabdominal examination) to select a method for correcting neurogenic voiding disorders, taking into account individual patient characteristics [39, 40].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
It is recommended that women with NLUTD undergo a digital rectal examination and vaginal examination to assess anal sphincter and pelvic floor muscle tone, urogenital zone sensitivity, detect signs of pelvic organ prolapse, and evaluate the anatomical and functional state of the pelvic floor (bimanual rectoabdominal examination, bimanual vaginal examination) to assess the effectiveness of methods correcting storage and voiding dysfunctions of the lower urinary tract and to decide on additional surgical intervention [39, 40].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comments: Anal sphincter tone is described as: enhanced, normal, weakened, or absent. Voluntary contraction of the anal sphincter and pelvic muscles is also assessed as: enhanced, normal, weakened, or absent.
2.3 Laboratory Diagnostics
Patients with NLUTD should be monitored for the onset of signs and symptoms of potential renal function impairment. The risk of upper urinary tract damage in NLUTD is higher in the presence of high detrusor pressure during the filling phase [41]. The risk of developing renal failure is significantly higher in patients with spinal cord injury or spina bifida compared to patients with slowly progressive diseases, including multiple sclerosis and Parkinson's disease [41, 42].
It is recommended that all patients with NLUTD undergo laboratory tests for in-hospital diagnostic purposes and preparation for surgical treatment, including complete blood counts and urinalysis, general clinical blood chemistry (total blood protein, blood albumin, blood urea, blood creatinine, aspartate aminotransferase activity, alanine aminotransferase activity, blood sodium, blood potassium, blood chlorides), and a coagulogram (prothrombin time in blood or plasma, blood fibrinogen, international normalized ratio [INR]) [43].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comments: Laboratory tests for surgical preparation can be performed in a hospital setting for immobile patients.
It is recommended not to perform routine screening (complete urinalysis or microbiological [culture] urine testing for bacterial pathogens using automated plating) for asymptomatic bacteriuria in patients with NLUTD due to the lack of clinical significance [44].
GPR CLoE 4Grade of Recommendation C (Level of Evidence 4).
Comments: Asymptomatic bacteriuria in men is defined as the isolation of a bacterial strain at a count of >10^5 CFU/mL in self-voided urine. Asymptomatic bacteriuria in women is defined as the isolation of the same bacterial strain at a count of >10^5 CFU/mL in two consecutive self-voided urine samples. Asymptomatic bacteriuria in both men and women is defined by the isolation of a bacterial strain at a count of >10^4 CFU/mL in urine collected from the urinary bladder via a urethral catheter [45].
It is recommended that patients with NLUTD presenting with symptoms such as pain, hyperthermia, and hematuria undergo additional examinations, including microbiological (culture) urine testing for bacterial pathogens using automated plating to rule out urinary tract infection [5, 38].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comments: Timely initiated treatment can prevent the development of irreversible changes in the lower and upper urinary tracts, including ascending pyelonephritis. Retention changes in the upper urinary tracts may be a sign of vesicoureteral reflux. In the presence of bacterial inflammation of the urinary system, vesicoureteral reflux can lead to life-threatening consequences. Hematuria may be a sign of a neoplastic lesion of the urinary system.
2.4 Instrumental Diagnostics
It is recommended that all patients with NLUTD undergo renal ultrasound and urinary bladder ultrasound with post-void residual urine measurement at initial presentation and during follow-up for non-invasive visualization of upper and lower urinary tract changes [46].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comments: Renal and bladder ultrasonography is not a specific diagnostic method for NLUTD; however, its primary value lies in being a non-invasive imaging method for visualizing upper and lower urinary tract changes and measuring post-void residual volume [47]. This is extremely important for patients at high risk of developing vesicoureteral reflux.
It is recommended that all patients with NLUTD undergo urine flow rate measurement (uroflowmetry) and cystometry for an objective assessment of lower urinary tract function and dysfunction, with non-invasive urodynamic studies preceding invasive ones [46, 47, 49].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comments: Urodynamic study is the only method that allows determination and characterization of lower urinary tract function and dysfunction, with separate evaluation of detrusor contractility and external urethral sphincter activity, as well as the synergism of their relaxation and tension during urination. To obtain reliable results, the test should be repeated if the initial one was not representative in the opinion of the patient and/or physician [47, 50].
Comprehensive urodynamic evaluation consists of a series of diagnostic procedures:
Non-invasive methods:
urine flow rate measurement (uroflowmetry) (if the bladder emptying phase is preserved)
post-void residual volume measurement (ultrasound scanning or single bladder catheterization)
Invasive methods:
cystometry
urethral pressure profilometry
It is recommended that all patients with NLUTD undergo urine flow rate measurement (uroflowmetry) followed by post-void residual volume assessment (via ultrasound scanning or single bladder catheterization measuring the drained urine volume) to evaluate lower urinary tract function [47].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comments: Uroflowmetry can only be performed in patients capable of spontaneous urination. Potential abnormalities include: low flow rate, reduced voided volume, interrupted urine stream, delayed onset of urination, and presence of residual urine. When interpreting test results in patients unable to urinate in a natural (physiological) body position, it should be considered that body position may affect both the voiding pattern and urine flow rate.
It is recommended that all patients with NLUTD undergo filling and voiding cystometry to evaluate lower urinary tract function [49].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comments: It is recommended to use a physiological bladder filling rate and normal saline at body temperature [51]. Complete bladder emptying is recommended before the study. Physiological fluid infusion rates and body temperature should be maintained during filling. Potential abnormalities include: detrusor overactivity, low bladder wall compliance, impaired bladder sensation, urinary incontinence, urethral incompetence or relaxation.
It is recommended that all patients with NLUTD undergo urine flow rate measurement (uroflowmetry) and cystometry combined with voiding cystourethrography to visualize the urinary tract during the filling and emptying phases of the bladder [47, 49, 52].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comments: The combination of filling cystometry and pressure-flow studies coupled with imaging (video-urodynamic study) is the "gold standard" for studying urodynamics in patients with NLUTD. At the same time, given the complexity of this procedure, it can be replaced by a comprehensive urodynamic study combined with standard voiding cystourethrography.
It is recommended that patients with NLUTD undergo cystoscopy in the presence of hematuria and/or prolonged voiding dysfunction to confirm or rule out bladder mucosa neoplasms and other pathological conditions of the bladder and urethra [46, 53].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comments: When performing cystoscopy in patients with neurological disorders, one should keep in mind the danger of involuntary spastic contractions of the lower limb muscles and the risk of autonomic dysreflexia. Some patients may require radiopaque imaging (micturition cystourethrography, evacuation cystourethrography, ascending urethrography), the indications for which in neurogenic lower urinary tract dysfunction (NLUTD) are not clearly defined. When prescribing such studies, one should be guided by general principles and indications.
2.5 Other Procedures
All patients with NLUTD require a consultation with a neurologist and/or neurosurgeon.
It is not recommended to routinely perform specific neurophysiological studies (electromyography, nerve conduction studies) in all patients with NLUTD due to the lack of indications [53].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comments: in some cases, during the diagnostic workup and urodynamic evaluation, it may be necessary to use additional neurological tests. Neurophysiological tests include:
electromyography (in neurophysiological mode) of the pelvic floor muscles and urethral sphincter (needle electromyography (one muscle); surface electromyography (one anatomical zone); recording of somatosensory evoked potentials of motor nerves and/or the anal sphincter;
pudendal nerve conduction study (measurement of the conduction velocity of an electrical impulse along the nerve);
determination of the latency period of the bulbocavernosus and anal reflexes; determination of evoked potentials from the clitoris or glans penis (recording of somatosensory evoked potentials of motor nerves); evaluation of bladder and urethral sensitivity (integrated electromyography of the external anal sphincter or pelvic floor) [54].
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
Timely initiated treatment can prevent the development of irreversible changes in the lower and upper urinary tracts. Renal failure is the main cause of mortality in patients who survive traumatic spinal cord injury.
The priority goals in the treatment of patients with NLUTD are:
protection of renal function and upper urinary tract;
ensuring safe intravesical pressure; restoration of lower urinary tract functions;
improving the patients' quality of life.
Maintaining detrusor pressure within safe limits, both during the filling phase and the voiding phase of the bladder, creates safe conditions for urine drainage from the upper to the lower urinary tract and significantly reduces urological mortality in patients with NLUTD [55]. There is no clear definition of safe pressure, but it is known that the main method for assessing the functional state of the lower urinary tract is a urodynamic study. For example, it is known that a bladder capacity of <200 ml and a detrusor pressure of >75 cm H2O are independent risk factors for upper urinary tract damage in patients with spinal cord injury [55]. Suppression of excessive detrusor pressure can lead to impaired bladder emptying, which must be taken into account when evaluating treatment efficacy and follow-up examination. In this case, patients are offered a urine drainage method, mainly intermittent catheterization.
It is recommended for the prevention of upper urinary tract damage and improvement of long-term outcomes, especially in patients with spinal cord injury above the sacral level or multiple sclerosis, to use a combination of various treatment methods (e.g., intermittent catheterization and M-cholinolytics (ATC – G04BD – drugs for urinary frequency and incontinence – antimuscarinic drugs) [56, 57].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comment: Also, the reduction of detrusor pressure contributes to the preservation of the urinary continence mechanism and, consequently, to the patient's social rehabilitation and quality of life. Furthermore, this is of paramount importance for the prevention of urinary tract infections [58].
3.1 Conservative Treatment
Conservative treatment of patients with NLUTD includes urine drainage methods to compensate for bladder evacuation function, drug correction of urine storage function, and pharmacotherapy for acute urinary tract infections.
In all patients with NLUTD, special attention is paid to behavioral therapy, which may consist in modifying fluid intake and bladder emptying regimens via intermittent catheterization. For example, the established optimal fluid intake volume for a spinal cord injury patient practicing intermittent catheterization is 1.5 liters of fluid per day [59]. Correction of identified disorders in the form of increasing the daily fluid intake and normalizing the intermittent catheterization regimen helps reduce the risk of complications such as urinary tract infections and improve quality of life. Pharmacotherapy depends on the type of NLUTD, while there is no single optimal pharmacological treatment regimen for NLUTD.
It is recommended to perform intermittent aseptic catheterization of the bladder 4–6 times a day as a standard treatment method for patients with NLUTD and impaired bladder emptying function [58, 59].
GGR ALOC 2Grade of recommendation A (Level of evidence 2).
Comments: Sterile intermittent catheterization is not a routine procedure. Aseptic intermittent catheterization serves as an alternative to sterile catheterization and is the standard treatment method for patients with impaired bladder emptying. For aseptic intermittent catheterization, the recommended catheter diameter is 12–16 Ch. The optimal catheterization frequency should be 4–6 times a day, and the bladder volume during catheterization should not exceed 400–500 ml. The risk of urinary tract infections when using hydrophilic catheters is 54% lower [60].
It is recommended to avoid indwelling transurethral catheterization and cystostomy in patients with NLUTD to reduce the rate of complications [61].
GCR CLOE 4Grade of Recommendation C (Level of Evidence 4).
Comments: An indwelling urethral catheter and, to a lesser extent, cystostomy are associated with various complications and the risk of urinary tract infections [61]. In some cases, when comprehensive patient care is unfeasible (e.g., in the absence of proper continuous care and inability to perform intermittent catheterization due to tetraplegia). At the same time, if long-term drainage with an indwelling urethral or suprapubic catheter is necessary, medical silicone drains should be preferred.
It is recommended to use peripheral electrical stimulation of motor nerves, such as the tibial nerve, to restore bladder function in patients with NLUTD in the presence of detrusor overactivity. [62, 63]
GGR BLOC 3Grade of recommendation B (Level of evidence 3).
Comments: it is known that strong contraction of the urethral sphincter and/or pelvic floor muscles, as well as anal dilatation, genital stimulation, and physical activity, reflexively inhibit urination. Electrical stimulation of afferent fibers of the pudendal nerve causes a powerful suppression of the micturition reflex and detrusor contractions [64]. This type of stimulation can facilitate the restoration of the balance between activating and inhibiting impulses at the spinal or supraspinal levels. In patients with multiple sclerosis, the efficacy of combination therapy significantly exceeds that of treatment with electrical stimulation alone. Preliminary data indicate the efficacy and safety of tibial nerve stimulation and transcutaneous electrical stimulation in the treatment of NLUTD. In post-stroke patients, transcutaneous electrical stimulation improves urodynamic parameters and quality of life. In patients with incomplete spinal cord injury or myelomeningocele, intravesical electrical stimulation helps increase bladder capacity and compliance, and enhances the sensation of bladder filling. In patients with neurogenic detrusor underactivity, intravesical electrical stimulation improves voiding quality and reduces post-void residual volume.
It is recommended in patients with NLUTD for the treatment of neurogenic detrusor overactivity, increasing bladder capacity, and reducing episodes of urinary incontinence, as the first-line therapy, to use monotherapy with M-cholinolytics (antimuscarinic drugs – G04BD: Drugs for urinary frequency and incontinence) or antispasmodics with M-cholinolytic activity (ATC – Antispasmodics in combination with other drugs A03ED) [65].
GCR ALEL 1Grade of Recommendation A (Level of Evidence 1).
Comments: M-cholinolytic drugs (G04BD: Drugs for urinary frequency and incontinence) for the treatment of detrusor overactivity approved for use in the Russian Federation:
Solifenacin** – starting dose 10 mg once daily
Trospium chloride – starting dose 15 mg 3 times daily
Oxybutynin – starting dose 5 mg 3 times daily
Tolterodine – 2 mg twice daily
Fesoterodine – 8 mg once daily
If therapy is ineffective in patients with neurological disorders, higher doses of anticholinergic drugs (N04A: Anticholinergic agents) may be required for maximum efficacy [66,67]. Drugs of this group should be taken continuously in the presence of overactive bladder symptoms, provided there is adequate efficacy and safety
It is recommended in patients with neurogenic detrusor overactivity failing first-line therapy to use a combination of different drugs for the treatment of urinary frequency and incontinence – G04BD (antimuscarinics) and antispasmodics with anticholinergic activity (ATC – Antispasmodics in combination with other drugs A03ED) for the management of NLUTD [68]
GGR ALOC 2Grade of recommendation A (Level of evidence 2).
Comments: Extended-release antimuscarinics (G04BD: Drugs for urinary frequency and incontinence) are less likely to cause a number of adverse effects, such as dry mouth [65]. Some drugs, such as oxybutynin, cross the blood-brain barrier and can cause cognitive impairment; they should be prescribed with caution to patients with cognitive deficits [69].
It is recommended not to prescribe anticholinesterase agents to patients with impaired bladder contractility (underactive detrusor) due to the lack of proven efficacy [70].
GPR BLEL 2Grade of Recommendation B (Level of Evidence 2).
Comments: The use of cholinesterase inhibitors in patients with NLUTD requires caution. It was previously thought that anticholinesterase agents could enhance detrusor contractility and improve bladder emptying, but they are not routinely used in clinical practice. The effects of pyridostigmine bromide** and neostigmine methylsulfate** have not been studied in this patient population.
It is recommended to prescribe alpha-adrenoreceptor antagonists to men with NLUTD to reduce bladder outlet resistance, decrease post-void residual urine volume, and reduce the risk of autonomic dysreflexia [71-75]
GGR ALOC 2Grade of recommendation A (Level of evidence 2).
Comments: Alpha-adrenoreceptor antagonists should be used with caution in patients receiving antihypertensive drugs or suffering from hypotension; monitoring of peripheral arterial blood pressure is required.
The following drugs are used for these purposes:
# Tamsulosin** 0.4 mg once daily # Silodosin 8 mg once daily
It is recommended to use beta-3 adrenoreceptor agonists with caution to reduce the severity of NLUTD symptoms, as reliable evidence of drug efficacy and safety is limited to a few common neurological conditions [76-79].
GPR BLEL 2Grade of Recommendation B (Level of Evidence 2).
Comments: In patients with spinal cord injury or multiple sclerosis, a trend toward improvement in several urodynamic parameters, except for detrusor overactivity, was demonstrated with mirabegron 50 mg compared with placebo, as well as significantly lower severity of lower urinary tract symptoms.
It is recommended not to administer antibacterial therapy to patients with NLUTD and asymptomatic bacteriuria, as this leads to the selection of significantly more resistant strains without improving outcomes [80].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comments: The main criterion for asymptomatic bacteriuria should be considered the absence of clinical manifestations of UTI in the presence of bacteriuria on urinalysis and quantitative urine culture.
It is recommended to prescribe antibacterial agents based on the antimicrobial susceptibility of urinary isolates to eradicate infectious agents in patients with clinically significant UTI [81, 82].
RG CLE 5Recommendation Grade C (Level of Evidence 5).
Comments: There is no consensus on the optimal duration of UTI therapy. Typically, a 5–7-day course of antibacterial agents is recommended, which can be extended up to 14 days depending on the clinical course of the UTI. It depends on the severity of the UTI and involvement of the kidneys and prostate. Long-term low-dose antibacterial therapy does not reduce UTI frequency but increases the risk of antimicrobial resistance. The choice of antibacterial agents is guided by the results of urine culture and susceptibility testing. If immediate treatment is required (febrile temperature, septicemia, intolerable clinical symptoms, severe autonomic dysreflexia), the choice of drug depends on local and individual resistance patterns.
3.2 Surgical Treatment
Surgical treatment of patients with NLUTD includes minimally invasive botulinum toxin therapy of the LUT, bladder augmentation procedures, and surgical correction of external urethral sphincter function.
It is recommended in patients with neurogenic detrusor overactivity refractory to conservative therapy to perform an endoscopic surgical procedure – pharmacological bladder denervation (intradetrusor injection of botulinum toxin type A**) to reduce the risk of secondary UUT complications and lower intravesical pressure [83, 84].
GGR ALOC 2Grade of recommendation A (Level of evidence 2).
Comments: In the Russian Federation, products approved for smooth muscle injection are used:
botulinum toxin type A** – at least 200 U per procedure.
botulinum toxin type A-hemagglutinin complex** – at least 200 U (onabotulinumtoxin) and at least 600 U (abobotulinumtoxin) per procedure.
Intradetrusor botulinum toxin injections are an effective treatment for NDO refractory to antimuscarinics (G04BD: Drugs for urinary frequency and incontinence). Botulinum toxin type A** induces long-lasting (approximately 9–11 months, depending on the product used) but reversible chemical denervation of the detrusor [85, 86]. If necessary, repeat injection can be performed no earlier than after 3 months, maintaining efficacy even in patients with poor response to the first injection. The most common complications include UTI and increased post-void residual urine volume. In some cases, clean intermittent catheterization is required. Rare but serious adverse events include autonomic dysreflexia and respiratory disorders. In addition, the development of generalized muscle weakness has been reported. Chemical denervation of the detrusor may necessitate clean intermittent catheterization [87, 88].
It is recommended in patients with NLUTD and detrusor-sphincter dyssynergia (DSD) to perform a minimally invasive endoscopic surgical procedure – sphincter botulinum toxin type A injection to reduce bladder outlet resistance [89].
GCR CLOCE 4Grade of Recommendation C (Level of Evidence 4)
Comments: In the Russian Federation, the following product is approved for injection into striated muscle in DSD:
botulinum toxin type A** – 100 U per procedure
The achieved therapeutic effect is relatively modest; the technique should be used only with the aforementioned botulinum neuropeptide agents approved for this indication (ATC: M03AX01 - Botulinum toxin). The complication rate is considered low [90].
It is recommended to perform sphincterotomy (division of the urogenital sphincter) or urethral stenting (urinary tract stent placement) in male patients with NLUTD and tetraplegia who are unable to perform clean intermittent catheterization regularly, provided a condom catheter can be used [91-93]
GPR BLEL 2Grade of Recommendation B (Level of Evidence 2).
Comments: By performing staged transurethral incisions of the sphincter zone, bladder outlet resistance can be reduced without compromising the closure function of the urethra. In many cases, sphincterotomy must be repeated; this technique provides good efficacy and does not cause severe complications [94].
It is recommended that female patients with NLUTD and neurogenic stress UI who are capable of self-catheterization undergo sling procedures for urinary incontinence to improve treatment outcomes [95, 96].
GGR BLEL 3Grade of Recommendation B (Level of Evidence 3).
Comments: Sling procedures for urinary incontinence have proven efficacy in women with neurogenic stress urinary incontinence who are capable of self-catheterization, yielding acceptable medium- and long-term outcomes. An increase in bladder outlet resistance is associated with the risk of elevated intravesical pressure. Methods to manage sphincter incompetence are indicated only when detrusor overactivity is controlled and significant VUR is absent. In select cases, concurrent bladder reconstruction (augmentation) is indicated [90].
It is recommended to perform sphincteroplasty with the implantation of an artificial urinary sphincter in men with neurogenic stress urinary incontinence to improve treatment outcomes [95].
GCR CLOE 4Grade of Recommendation C (Level of Evidence 4).
It is recommended to perform cystostomy in patients with impaired bladder emptying function when intermittent catheterization is not feasible due to tetraplegia, in order to reduce the number of complications and improve quality of life [96].
GCR CLOE 4Grade of Recommendation C (Level of Evidence 4).
Comments: Cystostomy may be used if conditions for intermittent catheterization are absent (urethral pathology, impaired hand function), as well as in cases of a sharp decrease in the storage function of the bladder. In patients with a long-term cystostomy, it is always advisable to conduct an examination to determine the possibility of switching to intermittent catheterization.
It is recommended to perform bladder reconstruction (augmentation) in patients with neurogenic lower urinary tract dysfunction (NLUTD) to reduce detrusor overactivity or improve bladder storage capacity when all less invasive treatments are ineffective [97-100].
GCR CLOE 4Grade of Recommendation C (Level of Evidence 4).
Comments: Bladder reconstruction (augmentation) is an effective intervention to reduce detrusor pressure and increase bladder capacity, and serves as the sole alternative when less invasive methods fail.
It is recommended to offer surgical treatment aimed at increasing bladder capacity by creating an artificial urinary reservoir, including the use of an intestinal segment (radical cystectomy with heterotopic urinary reservoir reconstruction; radical cystectomy with orthotopic urinary reservoir reconstruction; Bricker procedure [ureteroileocutaneostomy]), in patients with NLUTD and detrusor overactivity refractory to conservative treatment, in order to protect the upper urinary tract and improve the patient's quality of life [101-104].
LoR CGoE 3Level of Recommendation C (Level of Evidence 3).
Comments: Bladder reconstruction (augmentation) can be performed with preservation of the native bladder or via complete tissue replacement using an intestinal graft. The choice of subsequent urinary diversion method—via a catheterizable continent stoma or the natural urinary tract—depends on the technical feasibility of passing a catheter into the bladder cavity and is decided individually for each clinical case. A catheterizable continent stoma can be brought out (during bladder reconstruction) at any suitable site on the anterior abdominal wall, most commonly chosen in the umbilical region for cosmetic reasons. The patient should be informed about the high rate of postoperative complications, which include stoma stenosis, reservoir-skin fistula formation, bladder stones, and reservoir perforation.
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Rehabilitation of patients with NLUTD is carried out within the framework of stages 1, 2, and 3 of rehabilitation for the underlying neurological disease [105].
It is recommended to use absorbent products for patients in whom treatment for urinary incontinence is either impossible or associated with high risks [106, 107].
Level of Recommendations B (Level of Evidence 2)Level of Evidence 2Level of Recommendations B (Level of Evidence 2).
Comments: Absorbent products are essential for individuals with urinary incontinence when treatment is ineffective or not feasible. A number of patients prefer urine-collecting devices (latex male external catheters) over active treatment with its associated risks. These devices include absorbent pads, urethral catheters, external urine collection devices (latex male external catheters), male compression devices (reusable penile clamps for urinary incontinence), and intravaginal devices for women (bladder support pessaries).
It is recommended to use the intermittent bladder catheterization technique to reduce the frequency of clinically significant urinary tract infections (UTIs) in patients with impaired bladder contractility, as well as in patients with a non-relaxing external urethral sphincter [108].
GCR ALEL 1Grade of Recommendation A (Level of Evidence 1).
Comments: Lubricated catheters for self-catheterization are divided into two types based on their lubrication method:
Lubricated self-catheterization catheter with a fixed hydrophilic coating;
Lubricated self-catheterization catheter with an unfixed hydrophilic coating [1],[2].
It is recommended to perform pelvic floor muscle training, including biofeedback, in patients with neurogenic lower urinary tract dysfunction resulting from acute cerebrovascular accident, provided they have preserved partial or complete voluntary contraction of the perineal muscles, in order to improve treatment outcomes [109, 110].
Level of Recommendations B (Level of Evidence 2)Level of Evidence 2Level of Recommendations B (Level of Evidence 2).
Comments: This technique has also been studied in patients with multiple sclerosis [62, 63]. Combining muscle electrical stimulation with electromyographic biofeedback training is possible in central nervous system and brain disorders.
[1] GOST R 59449-2021. Care products for urinary stomas, male urinary incontinence, and urinary retention.
[2] Order of the Ministry of Labor and Social Protection of the Russian Federation No. 106n dated March 5, 2021 "On approval of the list of indications and contraindications for providing disabled persons with technical rehabilitation aids"
5. Prevention and Dispensary Observation
Patients with NLUTD are individuals with a chronic condition requiring lifelong medical supervision, regular laboratory and instrumental examinations, etc. Since NLUTD is not a primary disease, but a consequence of neurological pathology (diseases or injuries of the central or peripheral nervous system), there is no primary prevention for neurogenic voiding dysfunctions. It is advisable to implement timely diagnostic methods for pelvic organ dysfunction—specifically, storage and voiding disorders—and to prescribe the optimal method for correcting the identified disorders in the early stages following the onset of the underlying neurological pathology.
It is recommended to perform an annual urological examination of patients with NLUTD, including laboratory tests (complete urinalysis, blood urea, and creatinine) and instrumental studies (ultrasound of the kidneys and bladder with post-void residual urine determination, uroflowmetry, cystometry) to assess the patient's condition dynamically [111].
GGR BLEL 3Grade of Recommendation B (Level of Evidence 3).
Comments: NLUTDs often have an unstable course, and their symptoms can vary significantly, thus requiring regular follow-up. A patient's condition can change substantially even over a relatively short period. In the high-risk neurological patient group, this interval may be much shorter. Any clinically significant changes require additional evaluation [5, 47]. Urodynamic study is indicated both for initial diagnosis and during follow-up. It needs to be repeated more frequently in high-risk patients.
6. Organization of Medical Care
Indications for planned admission to a medical organization:
1) for the surgical treatment of NLUTD;
2) for performing cystoscopy and cystometry (including with anesthesia support) in patients with tetraplegia and paraplegia, and other groups of neurological patients with limited mobility.
Indications for discharging the patient from the hospital:
1. Restoration of complete or partial urinary continence in a patient with urinary incontinence;
2. Ensuring bladder emptying, independently or assisted, in a patient with impaired bladder emptying;
3. Ensuring the safety and proper function of the upper urinary tract.
7. Additional Information
Adequate compensation of neurogenic voiding disorders involves providing the patient with NLUTD with rehabilitation and habilitation technical aids and specialized medical devices (indwelling Foley urethral catheter for drainage, non-antibacterial; universal absorbent pads; portable reusable urinal; wearable urinal fixation device; single-use intermittent urethral catheterization kit for self-administration, reusable; urethral catheter for single drainage/irrigation). This can be done at the patient's own expense or through state provision. Free provision of technical rehabilitation aids (TRA) for voiding dysfunction requires referring the patient to a medical and social expert evaluation to assign disability status and determine the list of necessary medical devices and technical rehabilitation aids, which are then included in the individual rehabilitation and habilitation program for the disabled person.
The physician referring a patient with NLUTD for medical and social expert evaluation must select the type and category of the technical rehabilitation and habilitation aid for the specific patient, taking into account the existing voiding dysfunction and clinical manifestations.
Given the prolonged, sometimes lifelong use of methods to compensate for impaired urinary bladder function, the patient must be thoroughly trained in intermittent self-catheterization, or the caregivers of the specific patient must be trained in the principles of regular catheterization.
It is recommended to warn patients with spinal cord injury or functional spinal cord disorders localized at or above the Th6 segment about the high risk of developing autonomic dysreflexia [112].
Clinical manifestations of autonomic dysreflexia include headache, blurred vision, nasal congestion, piloerection, facial flushing, increased sweating above the level of the lesion (vasodilation), as well as pallor and cold skin (vasoconstriction) below the level of the lesion. Triggers for autonomic dysreflexia may include significant distension of the bladder or bowel, sexual stimulation, or any noxious stimulus. For example, iatrogenic stimuli during cystoscopy or urodynamic studies can induce autonomic dysreflexia [36, 113].
Criteria for Evaluating the Quality of Medical Care
№ | Quality criteria | Performance evaluation |
1. | An anamnesis was taken, including information on the onset of the neurological disease and the appearance of urological symptoms with an emphasis on previous or persistent symptoms, including urination, bowel, and sexual function, | Yes / No |
2. | A urination diary (determination of urine volume) was completed and analyzed in patients with preserved urination | Yes / No |
3. | A general (clinical) urine test was performed to diagnose lower urinary tract infection. | Yes / No |
4. | If a lower urinary tract infection is confirmed, a microbiological (culture) urine test for bacterial pathogens using automated seeding is performed | Yes / No |
5. | An assessment of reflexes in the urogenital zone was performed, particularly the bulbocavernosus reflex and the anal reflex | Yes / No |
6. | Measurements of urine flow rate (uroflowmetry), residual urine volume assessment, and cystometry were performed | Yes / No |
7. | Drug therapy for detrusor overactivity and urgency urinary incontinence was prescribed using an M-anticholinergic agent (G04BD: Drugs for urinary frequency and incontinence) (in the absence of contraindications) | Yes / No |
8. | Intermittent catheterization of the bladder was prescribed to patients who cannot completely empty their bladder, | Yes / No |
9. | For urgency urinary incontinence refractory to medical therapy, or in the presence of pronounced side effects or contraindications to use, intradetrusor botulinum toxin injection was performed | Yes / No |
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Lee KS, Han DH, Lee YS, Choo MS, Yoo TK, Park HJ, Yoon H, Jeong H, Lee SJ, Kim H, Park WH. Efficacy and safety of tamsulosin for the treatment of non- neurogenic voiding dysfunction in females: a 8-week prospective study. J Korean Med Sci. 2010 Jan;25(1):117-22. doi: 10.3346/jkms.2010.25.1.117. Epub 2009 Dec 26. PMID: 20052356; PMCID: PMC2800025.
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Welk B, Hickling D, McKibbon M, Radomski S, Ethans K. A pilot randomized- controlled trial of the urodynamic efficacy of mirabegron for patients with neurogenic lower urinary tract dysfunction. Neurourol Urodyn. 2018 Nov;37(8):2810-2817. doi: 10.1002/nau.23774. Epub 2018 Aug 31. PMID: 30168626.
Krhut J, Borovička V, Bílková K, Sýkora R, Míka D, Mokriš J, Zachoval R. Efficacy and safety of mirabegron for the treatment of neurogenic detrusor overactivity-Prospective, randomized, double-blind, placebo-controlled study. Neurourol Urodyn. 2018 Sep;37(7):2226-2233. doi: 10.1002/nau.23566. Epub 2018 Mar 31. Erratum in: Neurourol Urodyn. 2024 Jan;43(1):301. doi: 10.1002/nau.25272. PMID: 29603781.
Zhang D, Sun F, Yao H, Bao X, Wang D, Cui Y, Wu J. The Efficacy and Safety of Mirabegron for the Treatment of Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review and Meta-analysis. Front Pharmacol. 2021 Nov 18;12:756582. doi: 10.3389/fphar.2021.756582. PMID: 34867373; PMCID: PMC8636815.
Krebs J, Pannek J, Rademacher F, Wöllner J. Real-World Effects of Mirabegron in Patients with Chronic Neurogenic Detrusor Overactivity - A Retrospective Cohort Study. Res Rep Urol. 2020 May 22;12:187-192. doi: 10.2147/RRU.S253713. PMID: 32548077; PMCID: PMC7250696.
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Appendix A1. Working Group Composition
Kasyan Gevorg Rudikovich – Doctor of Medical Sciences, Professor at the Department of Urology, Russian University of Medicine of the Russian Ministry of Health, member of the Russian Society of Urology.
Krivoborodov Grigory Georgievich – Doctor of Medical Sciences, Professor at the Department of Urology and Andrology, Pirogov Russian National Research Medical University of the Russian Ministry of Health, member of the Russian Society of Urology.
Gadzhieva Zaida Kamaludinovna – Doctor of Medical Sciences, Leading Researcher at the Department of Functional Diagnostic and Treatment Methods, Scientific Research Institute of Uronephrology and Human Reproductive Health, Sechenov First Moscow State Medical University of the Russian Ministry of Health, member of the Russian Society of Urology.
Salyukov Roman Vyacheslavovich – Doctor of Medical Sciences, Associate Professor at the Department of Medical Rehabilitation, Institute of Neurosciences and Neurotechnologies, Pirogov Russian National Research Medical University of the Russian Ministry of Health, Researcher at the Russian Scientific Center of Roentgenoradiology of the Russian Ministry of Health, member of the Russian Society of Urology.
Al-Shukri Salman Khasunovich – Doctor of Medical Sciences, Professor, Head of the Department of Urology with a Urology Clinic Course, Pavlov First Saint Petersburg State Medical University of the Russian Ministry of Health, member of the Russian Society of Urology
Stroganov Roman Vasilyevich – Candidate of Medical Sciences, Assistant at the Department of Urology, Russian University of Medicine of the Russian Ministry of Health, member of the Russian Society of Urology
Conflict of interest: All Working Group members have confirmed the absence of financial support/conflict of interest that needs to be disclosed
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines:
urologists
neurologists
neurosurgeons
physical and rehabilitation medicine physicians
general practitioners (family physicians)
Table 1. Levels of Evidence (LoE) grading scale for diagnostic methods (diagnostic interventions)
LoE | Definition |
1 | Systematic reviews of studies with reference standard control or systematic reviews of randomized controlled trials with meta-analysis |
2 | Individual studies with reference method control or individual randomized clinical trials and systematic reviews of studies of any design, except for randomized clinical trials with meta-analysis |
3 | Studies without consecutive reference standard control or studies with a reference standard not independent of the test method, or non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case report |
5 | Only justification of mechanism of action or expert opinion is available |
Table 2. Scale for grading levels of evidence certainty (LEC) for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)
LoE | Definition |
1 | Systematic review of RCTs with meta-analysis |
2 | Individual RCTs and systematic reviews of studies of any design, except for RCTs using meta-analysis |
3 | Non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case reports or case series, case-control studies |
5 | Only justification of the mechanism of action of the intervention (preclinical studies) or expert opinion is available |
Table 3. Scale for grading grades of recommendation (GR) for prevention, diagnostic, treatment, and rehabilitation methods (preventive, diagnostic, therapeutic, and rehabilitative interventions)
GoR | Definition |
A | Strong recommendation (all considered efficacy criteria (outcomes) are important, all studies are of high or acceptable methodological quality, and their conclusions on the outcomes of interest are consistent) |
B | Conditional recommendation (not all considered efficacy criteria (outcomes) are important, not all studies are of high or acceptable methodological quality, and/or their conclusions on the outcomes of interest are inconsistent) |
C | Weak recommendation (lack of adequate quality evidence (all considered efficacy criteria (outcomes) are unimportant, all studies are of low methodological quality, and their conclusions on the outcomes of interest are inconsistent) |
Procedure for updating clinical guidelines.
The mechanism for updating clinical guidelines provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data on the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.
Appendix A3. Reference Materials
Order of the Russian Ministry of Health No. 907n dated November 12, 2012, "On Approval of the Procedure for Providing Medical Care to the Adult Population in the Profile 'Urology'."
Order of the Ministry of Health of the Russian Federation No. 114n dated February 21, 2020 "On Amendments to Certain Orders of the Ministry of Health and Social Development of the Russian Federation and the Ministry of Health of the Russian Federation Approving the Procedures for Providing Medical Care"
Order of the Ministry of Labor and Social Protection of the Russian Federation No. 137n dated March 14, 2018 "On Approval of the Professional Standard 'Urologist'"
Order of the Ministry of Labor and Social Protection of the Russian Federation No. 689n dated August 31, 2023 "On Amendments to Certain Professional Standards Approved by Orders of the Ministry of Labor and Social Protection of the Russian Federation"
Order of the Ministry of Labor and Social Protection of the Russian Federation No. 342n dated April 27, 2023 "On Approval of the List of Indications and Contraindications for Providing Disabled Persons with Technical Rehabilitation Means"
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
Pelvic floor disorders and, in particular, urinary disorders are characteristic manifestations of a number of neurological diseases and disorders of the central and peripheral nervous system.
If you have a neurological disease accompanied by urinary disorders, this condition requires specialized medical care provided by a urologist.
The main diagnostic method for neurogenic lower urinary tract dysfunction is a comprehensive urological examination, which involves measuring intravesical and intra-abdominal pressure during bladder filling with sterile saline and during urination.
The primary objectives in managing neurogenic urinary disorders are as follows:
creating conditions for the accumulation of a sufficient volume of urine in the bladder – approximately 300-500 ml; ensuring low intravesical pressure during the storage and voiding phases; preventing involuntary urine leakage outside the bladder emptying phase;
reducing the risk of urinary tract infections, which are promoted by residual urine, urinary tract stones, indwelling urinary catheters, etc.
In certain neurological conditions, physiological urination cannot always be restored. In such cases, the efforts of physicians will aim to improve quality of life (achieving a certain level of comfort through the use of care products).
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Neurogenic Bladder Symptom Score – Russian version of the Neurogenic Bladder Symptom Score (NBSS).
Source: Filippova E.S. et al. Russian-language version of the Neurogenic Bladder Symptom Score (NBSS). Urology. 2018;6:5-13. DOI: https://dx.doi.org/10.18565/urology.2018.6.5-13 (https://dx.doi.org/10.18565/urology.2018.6.5-13).
Original: Welk, B., Morrow, S., Madarasz, W., Baverstock, R., Macnab, J., & Sequeira, K. (2014). The Validity and Reliability of the Neurogenic Bladder Symptom Score. The Journal of Urology, 192(2), 452–457. doi:10.1016/j.juro.2014.01.027
Type: patient questionnaire
Target audience: the questionnaire is suitable for all patients, regardless of the type of neurogenic lower urinary tract dysfunction, presence or absence of spontaneous urination, and method of urine drainage.
The Neurogenic Bladder Symptom Score | ||
The questions in this questionnaire relate to urological issues you may be experiencing. Please answer them by selecting only one response provided for each question. Completing the questionnaire will take 5-10 minutes. When answering the questions, think about how your bladder normally functions and disregard temporary changes associated, for example, with an exacerbation of a urinary tract infection. You can answer all questions in the questionnaire regardless of whether you urinate independently, use catheters or urine collection devices, or have undergone bladder surgery. | ||
1. In most cases, I empty my bladder: | ||
via an indwelling urethral catheter or stoma drainage catheter into a wearable, closed adult urine bag | A | |
□ | into a urinal sheath (wearable penile urinal) | B |
using a single-use intermittent urethral catheter | C | |
urinating independently in the toilet | D | |
2. How often during the day do you experience involuntary urine leakage (including leakage around a catheter or cystostomy): | ||
more than once a day | 4 | |
□ | about twice a day | 3 |
□ | several times a week | 2 |
□ | rarely | 1 |
never experience involuntary urine leakage (0 points) | 0 | |
3. During the day, involuntary urine leakage (including leakage around the catheter or stoma drainage catheter) requires the use of: | ||
3 or more pads | 4 | |
□ | 2 universal absorbent pads | 3 |
□ | 1 universal absorbent pad | 2 |
minimal and does not require the use of a pad | 1 | |
I do not have involuntary urine leakage | 0 | |
4. During the day, urine leaks involuntarily (including leakage around an indwelling urethral catheter) or in such an amount that: | ||
underwear/pads are completely soaked | 4 | |
underwear/pads become wet | 3 | |
underwear/pads become damp | 2 | |
urine output is minimal | 1 | |
□ | urine does not leak | 0 |
5. When I sleep, the volume of involuntarily leaked urine (including leakage around a catheter or stoma drainage catheter) is: | ||
large (bedding/clothing is completely soaked) | 4 | |
moderate (bedding/clothing becomes wet) | 3 | |
small (bedding/clothing becomes damp) | 2 | |
minimal | 1 | |
I do not lose urine when I sleep | 0 | |
6. The volume of urine that I involuntarily lose depends on the amount of fluid I drink: | ||
yes, I constantly have to limit my fluid intake | 3 | |
yes, I sometimes have to limit my fluid intake | 2 | |
no, urine leakage does not force me to reduce my fluid intake | 1 | |
no, I do not leak urine | 0 | |
7. Urine leakage causes skin problems: | ||
yes, I have to consult a doctor regarding skin problems | 3 | |
yes, but I am able to cope with these problems on my own | 2 | |
no, urine leakage does not cause me skin problems | 1 | |
no, I do not have urine leakage | 0 | |
8. Urine leakage forces me to limit activities that I enjoy: | ||
yes, I have to limit any activity | 3 | |
yes, I have to give up certain activities | 2 | |
no, urine leakage does not limit my activity | 1 | |
no, I do not have urine leakage | 0 | |
9. A sudden urge to urinate (or bladder spasm) occurs: | ||
many times a day | 3 | |
several times a day | 2 | |
rarely | 1 | |
never | 0 | |
10. When I need to urinate (or catheterize): | ||
I must do it immediately, otherwise urine will leak involuntarily | 3 | |
I must do it within a few minutes, otherwise urine will leak involuntarily | 2 | |
I can wait until a convenient time without the risk of involuntary urine leakage | 1 | |
I do not think about urination because I use an indwelling urethral balloon catheter for drainage (non-antibacterial) or a stoma drainage catheter | 0 | |
11. I wake up at night to urinate (catheterize or empty the urine bag): | ||
three or more times a night | 4 | |
twice a night | 3 | |
once a night | 2 | |
rarely | 1 | |
never | 0 | |
19. For me, a urinary tract infection: | |
often requires hospitalization | 4 |
forces me to take antibiotics constantly | 3 |
can be treated at home using antibiotics, if necessary | 2 |
can be treated without antibiotics | 1 |
does not happen | 0 |
20. Kidney stones form in me: | |
more often than once a year | 3 |
less often than once a year | 2 |
occurred a long time ago | 1 |
have never occurred | 0 |
21. Bladder stones form in me: | |
more often than once a year | 3 |
less often than once a year | 2 |
occurred a long time ago | 1 |
have never occurred | 0 |
22. I need to take medications for my bladder (other than antibiotics): | |
yes, but I do not take them | 3 |
yes, I take them, but they cause pronounced side effects | 2 |
yes, I take them with minimal or no side effects | 1 |
no, I do not need such medications | 0 |
23. I believe that the medications I take for my bladder are: | |
not very effective | 3 |
partially effective | 2 |
effective | 1 |
I am not taking any bladder medications | 0 |
24. If your bladder were to work the same way for the rest of your life as it does now, how would you feel: | |
unhappy | 4 |
mostly dissatisfied | 3 |
mixed (equally satisfied and dissatisfied) | 2 |
mostly satisfied | 1 |
delighted | 0 |
It consists of 24 questions across domains: incontinence, storage and emptying, complications, and quality of life. The questionnaire results are interpreted by summing the scores obtained during completion. Either the total score or the score obtained in each of the 5 domains can be evaluated. A high score correlates with more pronounced lower urinary tract symptoms.
№ | NBSS scoring | |||
|---|---|---|---|---|
1 | Urinary diversion method | A – stoma drainage catheter or indwelling Foley urethral catheter for drainage, non-antibacterial; B – penile sheath (wearable urinal for the penis); C – intermittent urethral catheter for single drainage/irrigation | ||
D – spontaneous urination | ||||
Incontinence | Storage and emptying | Complications | ||
2 | Daytime incontinence frequency | (0-4) | ||
3 | Pad saturation | (0-4) | ||
4 | Number of pads | (0-4) | ||
5 | Nighttime incontinence | (0-4) | ||
6 | Fluid restriction | (0-3) | ||
7 | Skin problems | (0-3) | ||
8 | Activity limitation | (0-3) | ||
9 | Urgency frequency | (0-3) | ||
10 | Urgency | (0-3) | ||
11 | Nocturia | (0-4) | ||
12 | Maximum interval | (0-3) | ||
13 | Dry interval | (0-4) | ||
14 | Pain | (0-3) | ||
15 | Incomplete emptying | (0-3) | ||
16 | Stream | (0-3) | ||
17 | Straining | (0-3) | ||
18 | Frequency of infections | (0-4) | ||
19 | Severity of infections | (0-4) | ||
20 | Kidney stones | (0-3) | ||
21 | Bladder stones | (0-3) | ||
22 | Drug therapy | (0-3) | ||
23 | Treatment efficacy | (0-3) | ||
Domain scores | (0-29) | (0-22) | (0-23) | |
24 | Quality of life | (0-4) | ||
Appendix G2. Bladder Diary
Patient's Full Name:______ Date of Birth:______
Gender: M/F Date of Completion:______ Diary Page:
Time in 24-hour format | Volume of urine voided (ml) | Need to strain during urination (yes, no) | Urinary leakage and its grade 1 to 3* | Pad change (yes, no) | Activity during leakage (coughing, running, etc. or at rest) | Imperative urge and its severity on a scale from 1 to 10** | Fluid intake (ml) |
Total | |||||||
How would you rate the strength of your urinary stream during urination: 1 – no stream, urine comes out in drops; 2 – urinary stream is significantly weakened; 3 – urinary stream is slightly weakened; 4 – normal urinary stream (circle the number corresponding to the answer that suits you) | |||||||
How does your urinary disorder affect your quality of life and daily activity: 1 – very strongly affects; 2 – moderately affects; 3 – slightly affects; 4 – does not affect at all (circle the number corresponding to the answer that suits you) | |||||||
How would you feel if you had to live with your current urinary disorders for the rest of your life: 1 – extremely dissatisfied; 2 – dissatisfied; 3 – practically normal; 4 – absolutely normal (circle the number corresponding to the answer that suits you) | |||||||
Notes on the voiding diary:
* 1 – mild, 2 – moderate, 3 – severe urinary leakage, urine is practically not retained.
** 1 is the mildest degree and 10 is the most severe degree of imperative urge to urinate.
Appendix G3. Prevalence of Various Types of NLUTD According to International Literature
Diseases accompanied by neurogenic lower urinary tract dysfunction | Frequency in the general population | Type and frequency of neurogenic voiding dysfunction | |
Suprapontine and pontine lesions and diseases | |||
Cerebrovascular diseases (stroke) | 450 cases/100,000/year (Europe) [6] (10% of cardiovascular mortality cases). | Nocturia – overactive bladder (OAB) – urge urinary incontinence (UUI) – detrusor overactivity (other types of disorders are less common) [7]. In 57–83% of patients, symptoms appear within 1 month after stroke, and 71–80% experience spontaneous recovery after 6 months. Persistence of incontinence correlates with an unfavorable prognosis [8]. | |||
Dementia: Alzheimer's disease (80%), vascular (10%), other etiology (10%). | 6.4% of adults aged >65 years [9]. | OAB-NDO-detrusor overactivity in 25% of lower urinary tract dysfunction in Alzheimer's disease, >25% in other types of dementia: Lewy body dementia, normal pressure hydrocephalus, Binswanger's disease, Nasu-Hakola disease, and Pick's disease [10]. In elderly patients with dementia, lower urinary tract dysfunction occurs 3 times more frequently than in patients without it [9]. | |||
Parkinsonism Idiopathic Parkinson's disease: 75-80% of parkinsonism cases Parkinsonism associated (in 18%) with multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration. Lewy body dementia. Secondary parkinsonism (2%) | The second most common neurodegenerative disease after Alzheimer's disease. The prevalence of idiopathic Parkinson's disease increases with age [11]. Multiple system atrophy is the most frequent cause of parkinsonism. | The incidence of lower urinary tract symptoms at disease onset is 30%, and at 5 years – 70%. Storage phase symptoms: nocturia (78%) OAB-NDO – detrusor overactivity [12]. OAB and detrusor overactivity develop in the early phase, while internal sphincter deficiency and impaired contractility appear as the disease progresses. Complications of neurogenic lower urinary tract dysfunction (infection) are among the main causes of mortality in multiple system atrophy [1212,13]. | |||
Brain tumors | 26.8/100,000/year in adults (>19 years) (17.9 benign, 8.9 malignant) [14]. | Urinary incontinence develops predominantly with localization in the frontal lobe (part of frontal lobe syndrome or isolated frontal lobe lesion) [15]. | |||
Cerebral palsy | Cerebral palsy: 3.1-3.6/1,000 in children aged 8 years [16]. | 62% of women and 58% of men with cerebral palsy suffer from urinary incontinence. Detrusor overactivity is present in 70%. Recurrent urinary tract infections (UTIs) and radiological abnormalities occur in >10% of cases [17]. | |||
Brain injury | 235/100,000 per year [18]. | Storage symptoms – 44%, voiding symptoms – 38%, urodynamic abnormalities – 60% [19]. | |||
Pathology and diseases from the caudal brainstem to the sacral spinal cord | |||||
Spinal cord injury (SCI) | The prevalence of spinal cord injury in developed countries ranges from 280 to 906 per 1 million [20]. | Neurogenic detrusor overactivity and DSD (up to 95%) and detrusor underactivity (up to 83%), depending on the level of the lesion [21]. | |||
Spina bifida | Spina bifida 3-4/10,000. Lumbar and lumbosacral forms are the most common (60%) [22]. | Bladder function is impaired in 96% of patients with spina bifida [23]. | |||
Hereditary spastic paraplegia | Prevalence 1,3-9/100,000 [37] | Lower urinary tract symptoms in 75% of cases, predominantly urgency and dysfunctional voiding. Neurogenic detrusor overactivity is detected in 81% of patients (of which 76% are combined with DSD) [37] | |||
Pathology and diseases of the peripheral nervous system | |||||
Degenerative diseases of the lumbar spine Intervertebral disc pathology Degenerative diseases Disc herniation Lumbar spinal stenosis | In men (5%) and women (3%) >35 years old with pain syndrome associated with intervertebral disc herniation. Incidence: approx. 5/100,000/year. More frequent in women aged >45 years. | Difficulty urinating and ancontractile detrusor in 26% [24]. Detrusor underactivity up to (83%) [21]. | |||
Iatrogenic pelvic nerve injuries | Rectal cancer. Cervical cancer (multimodal treatment, radiotherapy, and surgical interventions). Surgical treatment of endometriosis. | Following abdominoperineal resection: acute urinary retention in 50%. Following total mesorectal excision: voiding dysfunction in 10-30% [25]. | |||
Peripheral neuropathy Diabetes mellitus Other causes of peripheral neuropathy leading to urological symptoms: alcohol abuse, lumbosacral herpes zoster and genital herpes, Guillain-Barré syndrome, porphyria, sarcoidosis. | The worldwide prevalence of treated diabetes mellitus is 8.3% [26]. | Urgency/frequency +/- urinary incontinence. In the late stage, hyposensitive and underactive detrusor [27]. | |||
Myasthenia gravis | Prevalence: 20/100,000 [43] | Daytime urinary frequency, nocturia, urinary incontinence [43] | |||
Disseminated diseases of the central nervous system | |||||
Multiple sclerosis | Prevalence: 83/100,000 in Europe [44] | At the onset of multiple sclerosis, 10% of patients experience voiding dysfunction, and 75% of patients develop it after 10 years of multiple sclerosis [45]. Detrusor overactivity: 65% [45], 43% [46] DSD: 35% [45, 46]. Detrusor underactivity: 25% [45] | |||
Appendix G4. Questions recommended for clinical history taking [36]
History section | Parameters to evaluate |
Remote history (childhood – adolescence – adulthood) | Risk factors for hereditary or familial diseases In women: menarche (age); may indicate a metabolic disorder Obstetric history Presence of diabetes mellitus Diseases, e.g., multiple sclerosis, Parkinson's disease, encephalitis, syphilis Trauma and prior surgeries, especially involving the spinal cord and central nervous system |
Current history | Concomitant medications Lifestyle (smoking, alcohol, or substance use); urination, bowel, and sexual function Changes in quality of life |
Specific urological history | Onset of urological disease Reduction of symptom severity after urination; determining the extent of the neurological process in the absence of obstructive uropathy Changes in bladder sensation Initiation of urination (normal, triggered, reflexive, strained, Credé maneuver) Interruption of urination (normal, paradoxical, passive) Enuresis Character and type of urination (catheterization) Voiding diary: frequency of urination, voided volume, urinary incontinence, and urgency |
Sexual history | Genital pathology and symptoms of sexual dysfunction Genital sensitivity Specific andrological history: erectile function, impaired or absent orgasm, ejaculation Specific gynecological history: dyspareunia (impaired or deficient) orgasms |
History of large bowel dysfunction | Frequency of bowel movements and fecal incontinence Urge to defecate Characteristics of defecation Rectal sensitivity Initiation of defecation (digital rectal stimulation) |