List of Abbreviations
UB – urinary bladder
Ultrasound – ultrasound examination
UDS – comprehensive urodynamic study (A12.28.006 – Uroflowmetry + A12.28.007 Cystometry + A12.28.008 Intraurethral pressure profilometry + A05.19.001.001 Pelvic floor muscle electromyography + A12.28.005 Residual urine volume measurement)
BCG – Bacillus Calmette–Guérin
BC – bladder cancer
NMI – non-muscle-invasive
Terms and Definitions
Bladder diverticulum – is the herniation of the bladder mucosa through the muscular fibers of the bladder wall, forming a thin-walled pathological cavity communicating with the bladder via a narrow or wide neck and typically characterized by incomplete emptying during urination.
Comprehensive urodynamic study – is a method allowing the evaluation of the storage and voiding functions of the bladder, sphincter function, and muscles involved in urination, thereby identifying potential causes of existing disorders (A12.28.006 – Uroflowmetry + A12.28.007 Cystometry + A12.28.008 Intraurethral pressure profilometry + A05.19.001.001 Pelvic floor muscle electromyography + A12.28.005 Residual urine volume measurement).
Detrusor (of the bladder) – is the muscular coat of the bladder consisting of three interwoven layers forming a single muscle that expels urine.
Bladder diverticulectomy – surgery to excise a pathological blind-ending pouch followed by the restoration of the anatomical integrity of the organ.
Transurethral video-endoscopic bladder diverticulectomy is an endoscopic procedure that involves incising the neck of a bladder diverticulum to widen the communication between the bladder cavity and the diverticular cavity using an instrument passed through the urethra.
Infravesical obstruction (IVO) is a general term describing obstruction during urination, characterized by increased detrusor pressure and reduced urinary flow rate. IVO is diagnosed by simultaneously measuring the urinary flow rate and detrusor pressure.
Intradiverticular tumor is a urothelial neoplasm originating from the mucosa of a bladder diverticulum.
Uroflowmetry (urine flow rate measurement) is a non-invasive screening diagnostic method used to evaluate the functions of the urinary system—the urethral sphincter and the urinary bladder.
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Bladder diverticulum is a herniation of the bladder mucosa through the muscular fibers of the bladder wall, forming a thin-walled pathological cavity that communicates with the bladder via a narrow or wide neck and, as a rule, is characterized by incomplete emptying during urination [10].
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
The causes of bladder diverticulum are divided into congenital and acquired. Unlike the acquired form, which is almost always associated with infravesical obstruction or neurogenic bladder dysfunction, congenital bladder diverticulum arises due to hypoplasia of the muscular layer of the bladder wall [1, 2]. The mechanism of diverticulum formation involves the effect of increased intravesical pressure on the bladder wall due to an obstruction to urine outflow and/or dyscoordinated contractions of muscle fibers or, in the case of congenital pathology, the effect of normal intravesical pressure on a weakened muscular bladder wall. These changes lead to the protrusion of the bladder mucosa between muscle fibers, forming "indentations" in the bladder wall, which serve as an organic substrate for further growth and diverticulum formation [3, 4].
1.3 Epidemiology of the Disease or Condition
Bladder diverticula can occur in all age groups; however, in 90% of cases, a bladder diverticulum is diagnosed in adults. Furthermore, bladder diverticula are more common in men than in women, with a ratio of about 9 to 1 in both children and adults [3, 5]. Congenital bladder diverticula occur in 1.7%, being more frequent in children under 10 years of age [6].
1.4 Features of Coding the Disease or Condition
N32.3 - Bladder diverticulum
1.5 Classification of the disease or condition
The most common classification of bladder diverticula is the division into congenital and acquired types [1, 10]. Russian and foreign literature also mention false diverticula or pseudodiverticula of the bladder [5, 11, 17]. This division is based on histological data regarding the structure of the diverticulum wall; for example, true diverticula were previously considered congenital, containing all layers of the bladder wall, whereas false diverticula were considered acquired, consisting only of the bladder mucosa. However, large pathological and anatomical studies of specimens obtained after cystectomy in both children and adults demonstrate contradictory results, as some children have diverticula that contain no muscular layer in their wall structure, while some adults are found to have acquired diverticula containing a muscular layer within their wall [5, 19]. The scientific literature also classifies diverticula by size: small (up to 4 cm) and large (greater than 4 cm), which are most often symptomatic [17].
1.6 Clinical presentation of the disease or condition
Bladder diverticula rarely cause pronounced symptoms and are most frequently discovered incidentally during evaluation for another unrelated condition, including urinary tract infections [10]. Because large bladder diverticula empty slowly or incompletely after urination, the resulting symptoms are often related to urine stasis within the diverticulum or compression of adjacent pelvic organs by the enlarged diverticulum [17].
Frequent symptoms include the sensation of incomplete bladder emptying, a feeling of heaviness in the lower abdomen, and two-stage urination in the presence of large bladder diverticula. However, these symptoms are non-specific and may be caused by prostate hyperplasia, urethral stricture, or other pathologies causing difficult urination. The most common early manifestation of congenital bladder diverticula is an acute urinary tract infection caused by urine stasis. Less common manifestations include hematuria, ureterohydronephrosis, abdominal discomfort, or a palpable abdominal mass [7, 8].
2. Diagnostics, medical indications and contraindications for diagnostic methods
Criteria for establishing the diagnosis/condition:
Heaviness in the lower abdomen, intermittent abdominal or lumbar pain, dysuria, two-stage urination, hematuria, and signs of a chronic or recurrent urinary tract infection [5].
A pathological cavity communicating with the bladder via an isthmus, often characterized by incomplete emptying or the presence of calculi and/or neoplasms according to imaging diagnostic methods [10, 12].
When a bladder diverticulum is suspected, differential diagnosis with various conditions of the urinary bladder, kidneys, and abdominal organs is mandatory. If lumbar pain is present, differential diagnosis is performed with nephrolithiasis, nephroptosis, ureteral stricture, and tumors of the bladder and upper urinary tract [10].
Bladder diverticula are often discovered incidentally during X-ray or ultrasound examinations and appear as a fluid-filled formation near the bladder. Examples of the differential diagnosis of such structures are provided below [9]:
- Anomalies of the uterus, ovaries, and fallopian tubes;
- Urachal cysts;
- Ureteral ectopia;
- Ureterocele;
- Müllerian cysts;
- Postoperative complications, for example, lymphocele.
2.1 Complaints and Anamnesis
The corresponding complaints and medical history are listed in section "1.6. Clinical Presentation".
2.2 Physical Examination
The corresponding physical examination findings are listed in section "1.6. Clinical Presentation".
2.3 Laboratory Diagnostics
It is recommended that all patients with suspected bladder diverticulum undergo a general (clinical) urine test and microscopic examination of the urine sediment for differential diagnosis and to rule out concomitant neoplasms [5, 18-23].
Level of Recommendations CLevel of Evidence 3Level of Recommendation C (Level of Evidence – 3)
Comments: no specific laboratory alterations have been described in the literature for bladder diverticula; urinalysis may reveal macro- and microhematuria, allowing for the suspicion of a bladder tumor or bladder stones [5, 18-23]. Most authors agree on the necessity of performing urine cytology, although databases for determining reference ranges have not yet been established [28].
All patients with suspected bladder diverticulum are recommended to undergo a general (clinical) blood test to rule out an acute inflammatory process [10].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
All patients with suspected bladder diverticulum are recommended to undergo a general biochemical blood test (assessment of blood creatinine levels, blood urea levels, blood albumin levels, blood potassium levels, blood sodium levels, and blood chloride levels) to evaluate renal function [11].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
2.4 Instrumental Diagnostics
Most frequently, a single imaging method is sufficient to diagnose a bladder diverticulum: bladder ultrasound (code A04.28.002.003), cystography (code A06.28.007), intravenous urography (code A06.28.002), contrast-enhanced computed tomography of the pelvic organs in men (code A06.21.003.003), contrast-enhanced computed tomography of the pelvic organs in women (code A06.20.002.003), and contrast-enhanced magnetic resonance urography (code A05.28.003.001). However, as part of the preoperative preparation for elective surgery, additional instrumental diagnostic methods may be required, such as ureteroscopy and urodynamic studies (UDS) [11].
It is recommended that all patients with suspected bladder diverticulum undergo a bladder ultrasound with post-void residual urine measurement (code A04.28.002.005) and a kidney ultrasound (code A04.28.001) to establish the diagnosis, perform differential diagnosis with other pathological conditions, and assess the condition of the renal parenchyma and pelvicalyceal system [10, 11].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: Ultrasound allows obtaining information on the presence of a urinary bladder diverticulum, its location, the isolated capacity of the diverticulum, the volume of post-void residual urine, and also makes it possible to diagnose comorbid conditions, such as bladder tumors or bladder stones, as well as to assess the state of the pelvicalyceal system.
In all patients with suspected urinary bladder diverticulum in whom ultrasound examination failed to confirm or exclude the presence of a diverticulum, cystography (code A06.28.007), intravenous urography (code A06.28.002), contrast-enhanced computed tomography of the pelvic organs in men (code A06.21.003.003), and contrast-enhanced computed tomography of the pelvic organs in women (code A06.20.002.003) are recommended to establish the diagnosis and perform differential diagnosis with other pathological conditions [10, 24].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comments: ultrasound does not always reliably determine whether an anechoic mass in the pelvic cavity is a urinary bladder diverticulum; in such cases, the use of additional diagnostic imaging methods is considered appropriate. According to radiologists' experience, the sensitivity of computed tomography in detecting intradiverticular tumors reaches 82–94%, and the sensitivity in determining extravesical extension is 71–86% [24]. The sensitivity of excretory urography in the diagnosis of urinary bladder diverticula and intradiverticular tumors does not exceed 50% [18, 21].
It is recommended that all patients with suspected urinary bladder diverticulum undergo cystoscopy to confirm the diagnosis and rule out a diverticular tumor [23].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
It is recommended that all patients with suspected urinary bladder diverticulum scheduled for surgical treatment undergo urodynamic study (UDS) to obtain data on the functional state of the urinary bladder [11].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comments: UDS is necessary to determine the contractility of the urinary bladder and cystometric capacity. Uroflowmetry allows assessing the degree of bladder outlet obstruction, which facilitates differential diagnosis.
2.5 Other Procedures
There is no data on other diagnostic study methods for suspected urinary bladder diverticulum.
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
For urinary bladder diverticula, conservative and surgical (laparoscopic, endoscopic) treatment can be used. Indications for the treatment of urinary bladder diverticula include:
- chronic/recurrent urinary tract infection;
- bladder stones/diverticular stones;
- tumor of the bladder/diverticulum.
Malignant neoplasms of a urinary bladder diverticulum pose a particular danger due to the lack of a well-developed muscular wall in the diverticulum structure, which leads to a higher risk of tumor growth spreading beyond the urinary bladder [12].
3.1 Conservative Treatment
Patients with minor or absent symptoms and without concomitant aggravating circumstances (stones, bladder tumor) may be offered monitoring and observation. However, such patients must be informed about the potential increased risk of developing bladder tumors and stones. The duration of follow-up and visit schedule are selected individually; the examination consists of taking complaints and medical history, physical examination, complete urinalysis and urine cytology, as well as cystoscopy. For patients with contraindications to surgical treatment or in cases of surgical treatment failure, clean intermittent self-catheterization may be offered.
It is recommended to offer follow-up by a urologist (appointment (examination, consultation) with a urologist) to patients with no symptoms associated with the urinary bladder diverticulum and/or in whom surgery is contraindicated, in order to monitor the course of the disease [13].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
3.2 Surgical Treatment
Surgical treatment of a urinary bladder diverticulum—bladder diverticulectomy—is almost always performed on an elective basis. Currently available methods include open and video-endoscopic (endoscopic, laparoscopic, extraperitoneoscopic) interventions [10, 12-16].
3.2.1 Diverticulectomy
Bladder diverticulectomy is the only radical treatment method for a urinary bladder diverticulum. It can be performed via open, laparoscopic, or retroperitoneoscopic approaches [12].
Indications for bladder diverticulectomy include:
- voiding dysfunction due to compression of the bladder neck by a large urinary bladder diverticulum;
- unilateral or bilateral hydronephrosis due to compression of the upper urinary tract by the diverticulum (lower 1/3 and intramural part of the ureter, ureteral orifice);
- diverticulitis/acute cystitis refractory to conservative antibiotic therapy;
- stones within the cavity of the urinary bladder diverticulum;
- neoplasms in the area of the urinary bladder diverticulum;
- surgical treatment of concurrent bladder outlet obstruction [10, 15, 16, 21, 17].
Prior to surgery, a standard preoperative workup is performed, as well as additional diagnostic measures if required by the patient's medical history.
All patients with indications for surgical treatment of a urinary bladder diverticulum are recommended to undergo bladder diverticulectomy (A16.28.028 Bladder diverticulectomy) to eliminate symptoms associated with the diverticulum [10, 17].
Level of Recommendations CLevel of Evidence 3Level of Recommendation C (Level of Evidence – 3)
Comments: both open, laparoscopic, and retroperitoneoscopic approaches allow achieving good functional outcomes; however, given the appropriate technical equipment, video-endoscopic methods should be preferred as they are associated with a shorter hospital stay and lower analgesic requirements, despite an increase in average operative time [14]. Robotic surgery yields results comparable to laparoscopic techniques, with an average hospital stay of 2.4 days [15, 16].
3.2.2 Transurethral incision of the diverticular neck
Video-assisted endoscopic bladder diverticulectomy aims to create a wide communication between the bladder cavity and the diverticulum cavity, thereby stopping residual urine from pooling in the diverticulum and eliminating and/or reducing the risk of complications [12].
Patients with symptoms are recommended to undergo video-assisted endoscopic bladder diverticulectomy (code A16.28.028.001) to treat complications associated with the urinary bladder diverticulum [17].
Level of Recommendations CLevel of Evidence 3Level of Recommendation C (Level of Evidence – 3)
Comments: Video-assisted endoscopic bladder diverticulectomy (or i.e. transurethral incision of the diverticulum neck) is a minimally invasive and effective surgery that is well suited both for somatically compromised patients and for patients to whom video-assisted endoscopic bladder diverticulectomy can be offered as an alternative to open and laparoscopic procedures without negative consequences for subsequent radical treatment if the disease course so requires [10].
3.3 Treatment of diverticular tumors
See the clinical guidelines of the Russian Ministry of Health "Bladder Cancer".
4. Medical Rehabilitation and Sanatorium-Resort Treatment
No specific recommendation is required.
5. Prevention and Dispensary Observation
It is recommended to provide follow-up by a urologist (appointment (examination, consultation) with a urologist) for patients with no symptoms associated with the urinary bladder diverticulum and/or in whom surgery is contraindicated, in order to monitor the disease course [10].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to perform a complete (clinical) urinalysis and microscopic examination of the urine sediment in patients under surveillance for a urinary bladder diverticulum [10].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: the duration of follow-up and the visit schedule must be determined individually for each patient.
6. Organization of Medical Care
Indications for planned hospitalization:
1) instrumentally confirmed urinary bladder diverticulum complicated by symptoms, stones, or a tumor, requiring surgical treatment.
Indications for emergency hospitalization:
1) acute cystitis, diverticulitis refractory to conservative treatment.
Indications for patient discharge from a medical organization:
1) Absence of the need for inpatient monitoring and treatment after the performed surgery.
2) Absence of purulent-septic complications after the surgical intervention.
3) Absence of thromboembolic complications after the surgical intervention.
4) Restoration of adequate urination achieved, post-void residual urine volume reduced or eliminated.
Criteria for Evaluating the Quality of Medical Care
№ | Quality criteria | Performance assessment (yes/no) |
|---|---|---|
1. | Diagnosis, including differential diagnosis, performed using laboratory and imaging methods. | Yes/no |
2. | Microscopic examination of urine sediment and cystoscopy performed to rule out a diverticular and/or bladder tumor. | Yes/no |
3. | CMG was performed, or urine flow rate measurement (uroflowmetry) and bladder ultrasound with post-void residual urine determination as part of preoperative preparation to predict postoperative bladder function. | Yes/no |
4. | Bladder diverticulectomy was performed in patients with indications and absence of contraindications. | Yes/no |
5. | Bladder ultrasound with post-void residual urine determination and renal ultrasound were performed to establish the diagnosis and perform differential diagnosis with other pathological conditions. | Yes/no |
References
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Appendix A1. Working Group Composition
Popov Sergey Valerievich – MD, Professor, Honored Doctor of the Russian Federation, Chief Physician of St. Luke's Clinical Hospital of Saint Petersburg, Head of the Department of Surgery and Urology named after B.I. Miroshnikov of the Medical Institute of the St. Petersburg Medical and Social Institute, Professor of the Department of Urology at the S.M. Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation, member of the Russian Society of Urology, member of the Russian Society of Onkourology.
Guseynov Ruslan Guseynovich – PhD in Medicine, Deputy Chief Physician for Research at St. Luke's Clinical Hospital of Saint Petersburg, Associate Professor at the Department of Surgery and Urology named after B.I. Miroshnikov of the Medical Institute of the St. Petersburg Medical and Social Institute, member of the Russian Society of Urology, member of the Russian Society of Onkourology.
Beshtoev Akhmed Khatauovich – Researcher at St. Luke's Clinical Hospital of Saint Petersburg, member of the Russian Society of Urology.
Malyshev Egor Alekseevich – Researcher at St. Luke's Clinical Hospital of Saint Petersburg, member of the Russian Society of Urology.
Conflict of interest: the authors declare no conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines:
1. Urologists.
2. Oncologists.
3. General practitioners (internists).
4. General practice physicians (family medicine).
5. Surgeons.
6. Anesthesiologists-resuscitologists.
7. Radiologists.
8. Radiotherapists.
9. Pediatricians.
9. Pathologists.
Table 1. Scale for assessing the levels of evidence (LE) 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 standard control or individual randomized controlled trials and systematic reviews of studies of any design, except randomized controlled 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 assessing levels of evidence (LE) for methods of prevention, treatment, and medical rehabilitation, including those based on natural therapeutic factors (preventive, therapeutic, and rehabilitation interventions)
LoE | Definition |
|---|---|
1 | Systematic review of RCTs with meta-analysis |
2 | Individual RCTs and systematic reviews of studies of any design except RCTs, with 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 assessing grades of recommendation (GR) for methods of prevention, diagnostics, treatment, and medical rehabilitation, including those based on natural therapeutic factors (preventive, therapeutic, and rehabilitation 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
These clinical guidelines were developed taking into account the following regulatory legal documents:
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'."
Appendix B. Physician Action Algorithms
Figure 1. Diagnostic and treatment algorithm upon confirmation of the diagnosis of bladder diverticulum.
Appendix C. Patient Information
The patient is informed about the clinical presentation of the disease, various treatment methods, and their potential outcomes. The choice of treatment method should be made as a result of this discussion after the patient has had the opportunity to ask all questions of interest.
The patient must be informed about the possible clinical courses of the disease and the risks associated with the presence of a bladder diverticulum.
The patient should be informed about the symptoms and various complications of a bladder diverticulum, including secondary stone formation, development of bladder cancer, and chronic urinary tract infection.
The patient must be informed about the potential risks and consequences of both surgical treatment (transurethral incision of the bladder diverticulum neck, laparoscopic diverticulectomy, robot-assisted transperineal diverticulectomy, etc.) and active surveillance (perforation of the bladder wall, development of a neoplasm within the bladder diverticulum cavity).
Patients under follow-up must report changes in symptoms and their general condition to their attending urologist to prevent complications and make timely decisions regarding further management.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
None provided.