List of Abbreviations
CT — computed tomography
ICD-10 – International Classification of Diseases 10th Revision
MRI — magnetic resonance imaging
US — ultrasound
Terms and Definitions
Vesicovaginal fistula – an abnormal communication between the urinary bladder and the vagina.
Urethrovaginal fistula – an abnormal communication between the urethra and the vagina.
Vesicouterine fistula – an abnormal communication between the urinary bladder and the uterine cavity or cervical canal.
Ureteral fistulae – abnormal communications between the ureter and the vagina/intestine.
Fistuloplasty – surgery to close a urogenital fistula (vesicovaginal, urethrovaginal, vesicouterine, ureterovaginal).
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Fistula – an abnormal communication (tract) formed between two adjacent hollow organs or between hollow organs and the external skin.
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
Urogenital fistulae are the consequence of complications from obstetric procedures or surgical interventions, radiation therapy, oncological diseases, and genitourinary trauma. In addition, the formation of enterourogenital fistulae can be caused by tumor or inflammatory diseases of the pelvic organs.
It is widely believed that urogenital fistulas as a complication of pelvic surgery are the result of direct trauma to the lower urinary tract during surgery, often performed for emergency indications, since the surgeon's haste and inattentiveness increase the risk of lower urinary tract injury. Hysterectomy is the most common cause of urogenital fistulas. In most cases, fistulas form as a result of injuries caused by altered anatomy of the pelvic organs or adhesions between the bladder and the uterus or cervix, for example, due to previous surgeries in this area, endometriosis, and infectious complications [1].
Urethrovaginal fistulas usually result from injuries to the urethra during obstetric or vaginal procedures. Urethral injury can occur, for example, during anterior colporrhaphy, removal of vaginal cysts, paraurethral cysts, or urethral diverticula [2].
Vesicouterine fistulas are most commonly caused by bladder injury during lower uterine segment cesarean section.
Ureterovaginal fistulas are more frequently formed after radical surgeries for malignant lesions of the uterine cervix and body, hysterectomy for large uterine myomas, and ovarian surgery. Ureteral injury may also occur as a result of thermal damage during laparoscopic procedures involving coagulation or ligation [2]. Intraoperative diagnosis of urinary system injury is achieved in only half of the cases [3].
1.3 Epidemiology of the Disease or Condition
According to 15 European studies, including Russian ones, which investigated the causes of fistulas in 2,055 female patients, 1,710 (83.2%) had a surgical etiology [4]. In African countries, by contrast, out of 10,398 fistulas, only 459 (4.4%) were of surgical etiology, while the rest were obstetric [5]. Open hysterectomy accounted for 46.2% of fistula cases, hysterectomy via any approach was the etiological factor in 62.7% of all fistulas, and 75.4% of the 1,710 fistula cases resulted from surgical intervention [4]. Some cases were associated with other types of pelvic surgery (12.7%), usually oncological. According to the same data, radiotherapy is the cause of urogenital fistulas in 13% of patients.
Urogenital fistulas in women are a pressing issue in Russia. Several decades ago, iatrogenic injuries were the main cause of their occurrence. In 2020, a systematic analysis of PubMed and eLibrary database articles was conducted, containing information on the etiology, surgical techniques, and postoperative outcomes of treatment for urogenital fistulas in women. The results were compared with European data. Sixteen articles over a 20-year period meeting the inclusion criteria were selected. Iatrogenic injury caused fistula formation in 40.54% (373/920) of cases. The majority were post-radiation fistulas at 58.91% (542/920). A total of 84.02% (773/920) of the fistulas were successfully cured. The proportion of recovered patients with post-radiation fistulas was 75.83% (411/542). Comparing surgical techniques was difficult, as in most cases the choice was determined by the operating surgeon's preference [6].
1.4 Features of Coding the Disease or Condition
N82 Noninflammatory disorders of vagina and cervix, not elsewhere classified
N82.0 Vesicovaginal fistula
N82.1 Other female genital tract-bladder fistulas (cervicovesical, ureterovaginal, urethrovaginal, uteroureteral, uterovesical)
N82.9 Female genital tract fistula, unspecified
N36.0 Urethral fistula
N32.1 Vesicocolic fistula
N32.2 Bladder fistula, not elsewhere classified
1.5 Classification of the disease or condition
A unified classification still does not exist due to the wide variety of this pathology. The system proposed by Professor Kan is most frequently used in our country.
The classification presented by D. V. Kan describes the following types of fistulas:
• Vesicovaginal fistulas.
• Vesicouterine fistulas.
• Vesicoappendiceal fistulas.
• Urethrovaginal fistulas.
• Ureterovaginal fistulas.
• Ureterouterine fistulas.
• Combined, or ureterovesicovaginal fistulas.
• Associated fistulas, or involvement of the urogenital organs and bowel.
This classification is based on the localization of the fistula and the organs involved in the pathological process, and is widely used in clinical practice in our country.
Many other classifications of urogenital fistulas based on anatomical landmarks and etiological factors are described in the literature.
The Goh classification includes localization, fistula size, and the condition of the tissues and ureters [7].
Localization:
• Type 1 distal edge of the fistula >3.5 cm from the meatus
• Type 2 distal edge 2.5–3.5 cm
• Type 3 distal edge 1.5–2.5 cm
• Type 4 distal edge <1.5 cm
Size:
• (A) <1.5 cm
• (B) 1.5–3 cm
• (C) >3 cm
Tissues and ureters:
I no/moderate fibrosis around the fistula or vagina, and/or vaginal length >6 cm or normal
II moderate or severe fibrosis around the fistula and/or vagina and/or reduced vaginal length
III special types, e.g., peripheral fistula, involvement of ureteric orifices
The Waaldijk classification is presented below and is based on localization, fistula size, and the degree of involvement of the urethral sphincter mechanism [8].
Type or size of fistula | Subcategory | Description Fistula not involving the urethral closing mechanisms |
|---|---|---|
Type I | Fistula without (sub)total urethral involvement | |
Type II A | a | Without circumferential defect* |
b | With circumferential defect | |
Fistula with (sub)total urethral involvement | ||
Type II B | a | Without circumferential defect* |
b | With circumferential defect | |
Type III | Miscellaneous, e.g., ureteral and other complex fistulas | |
Small | <2 cm | |
Neuter | 2–3 cm | |
Large | 4–5 cm | |
Extensive | 6 or more cm |
The World Health Organization classification is based on the expected complexity of the surgery and has prognostic significance.
1.6 Clinical presentation of the disease or condition
The clinical presentation of the disease depends on the type of fistula and its size.
Urogenital fistulas in women manifest as constant involuntary urine leakage outside the urethra. As a rule, patients lack spontaneous urination, especially in cases of extensive defects. In some situations, urination may persist, partially or completely. In cases with a pronounced tissue defect, such as obstetric or radiation fistulas, the clinical picture is unquestionable. However, in pinprick gynecological fistulas, the clinical picture is less typical, and the fistula tract is quite small, which complicates its visualization and diagnostics.
Clinical manifestations of urethrovaginal fistulas depend on the size and localization of the fistulas. When the fistula opening is located in the distal section, urinary continence is preserved, but during urination, urine escapes through the fistula opening. When the fistula is located in the middle or proximal section, urine leaks constantly.
Female patients with vesicouterine fistulas after a cesarean section may remain "dry" due to the high location of the fistula—at the level of the uterine isthmus—and complain of cyclic hematuria or menouria. In other cases, patients present with symptoms of watery vaginal discharge or transient urinary incontinence associated with changes in body position.
Ureterovaginal fistulas are characterized by constant urine leakage combined with normal urination. Sometimes the disease debuts with acute obstructive pyelonephritis or pain on the affected side without signs of urinary tract infection. After the fistula forms, patients note the disappearance of pain and normalization of body temperature. In most cases, ureterovaginal fistulas impair renal function.
When intestinal fistulas develop, symptoms of urine discharge from the rectum occur. Hematuria, fecosuria, and pneumaturia may also be present. A vesicorectal fistula may also be accompanied by local pain, and recurrent or chronic urinary tract infections.
2. Diagnostics, medical indications and contraindications for diagnostic methods
Criteria for establishing the diagnosis of urogenital fistula based on pathognomonic data:
Presence of a pathological tract (passage) between the urinary tract and the genitalia, intestines, or skin,
Confirmation that urine is leaking from a site other than the urethra,
Visualization of the fistula tract during physical examination or using instrumental and diagnostic imaging methods,
2.1 Complaints and Anamnesis
If a urogenital fistula is suspected and a standard speculum examination fails to visualize the fistula tract, additional diagnostic methods are employed before deciding on the appropriate management strategy.
Main diagnostic principles:
· Confirm that the discharge is urine,
· Confirm that urine leakage occurs outside the urethra,
· Determine the localization of the fistula.
· Exclude or confirm ureteral involvement.
It is recommended to clarify the following details during the medical history taking in all patients to verify the diagnosis of urogenital fistula [1], [9]:
o Details of previous pelvic surgeries
o Details of previous pelvic radiation therapy
o Obstetric history
o Nature of urine discharge from the genital tract
o Time of fistula onset
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: previous radiation therapy significantly reduces the probability of successful fistula closure. The time elapsed between the onset of the fistula (urine leakage) and surgery determines the condition of the tissues. The average interval between the onset of the fistula and the optimal time for fistuloplasty ranges from 1–2 months up to 6 months (for radiation fistulas) [9].
2.2 Physical Examination
All patients with suspected urogenital fistula are recommended to undergo a physical examination in the gynecological chair to verify the diagnosis [2].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: examination of patients with radiation fistulas can be extremely painful and should be performed appropriately in the gynecological chair [1]. The purpose of the examination is to visualize the fistula, assess its size, and evaluate the condition of the surrounding tissues [10].
It is recommended that female patients with suspected urogenital fistula undergo a bladder filling test with a colored liquid or intravenous contrast enhancement to visualize the fistula tract and determine its localization and size [11].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
2.3 Laboratory Diagnostics
Patients with urogenital fistulas are not recommended to undergo a complete (clinical) urinalysis or microbiological (culture) urine test for aerobic and facultatively anaerobic opportunistic microorganisms prior to fistuloplasty due to the low information value of the study [2].
GRC CLeE 5Grade of Recommendation C (Level of Evidence – 5)
2.4 Instrumental Diagnostics
It is recommended to perform cystoscopy in female patients with urogenital fistulas prior to surgical intervention to visualize the fistula, determine its relationship with the ureters, assess the condition of the tissues, and rule out the presence of foreign bodies in the bladder (calculi, sutures, etc.) [9].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comments: during cystoscopy, a decision may be made to stent the ureters, remove urinary stones, or take a biopsy sample. Cystoscopy can be performed with simultaneous intravenous administration of indigo carmine to visualize the ureteral orifices.
It is recommended to perform a renal ultrasound in female patients with suspected urogenital fistula to rule out upper urinary tract obstruction [12], [13], [14], [15].
GPP CLEL 4Level of Evidence Recommendation C (Level of Evidence – 4)
Comments: Ultrasound makes it possible to diagnose associated ureteral trauma. Dilation of the pelvicalyceal system indicates impaired urine outflow from the kidney and the secondary nature of the disease [13].
It is recommended that female patients with urogenital fistulas and suspected or confirmed associated ureteral trauma undergo computed tomography (CT) of the kidneys and upper urinary tracts with intravenous bolus contrast enhancement or magnetic resonance imaging (MRI) of the urinary system to clarify the diagnosis [12], [14], [16], [17].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: CT of the kidneys and upper urinary tracts with intravenous bolus contrast enhancement and delayed excretory phase reliably diagnoses urogenital fistulas and provides information on ureteral integrity and the presence of urinary extravasation. MRI, particularly in T2-weighted mode, also provides optimal diagnostic information regarding fistulas and may be preferred for uterine or vesicointestinal fistulas [16].
2.5 Other Procedures
It is recommended that patients with urogenital fistulas undergo cystography to assess bladder capacity and visualize the fistula, as well as fistulography and/or protovaginography (vaginography) when combined and complex fistulas are suspected, in order to verify them [2], [11].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: Cystography is not a particularly informative study for diagnosing pinprick vesicovaginal fistulas, as the dye test under direct visual control provides more information about the size and localization of the fistula tract. However, cystography can be very useful for diagnosing vesicouterine fistulas. Cystography is of major importance in diagnosing complex fistulas involving the bowel, bladder, and vagina [11]. To perform fistulography, a ureteral catheter can be used; if the fistula opening is sufficiently large, an indwelling urinary balloon catheter (Foley catheter) can be used, through which the contrast medium is injected. Fistulography is particularly informative in fistulas opening into an abscess cavity, when a probe or catheter fails to trace the entire fistula tract.
Protovaginography (vaginography) is another study using contrast media to fill the vagina, which is then obstructed by the balloon of a Foley catheter. Injecting the contrast medium into the vagina makes it possible to visualize its passage into the bladder or ureter. This method remains highly valuable for diagnosing combined fistulas—when the integrity of both the bladder and the ureter is simultaneously compromised [2].
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
Treatment of a urogenital fistula should consist of eliminating the pathological urinary tract passage, restoring urine outflow from the kidneys, and improving the patient's quality of life. When planning surgical treatment, the timing of the surgery must be strictly observed. It should not be forgotten that epithelialization is a prolonged process, and the success of fistuloplasty directly depends on tissue "readiness." If bladder or ureteral trauma is noticed during surgery, immediate surgical correction is always indicated if the patient's condition permits and urinary extravasation could cause significant damage. In all other cases, such injuries can be managed in two stages—that is, by bladder drainage or stenting of the injured ureter followed by reconstructive surgery.
3.1 Non-pharmacological therapy
In punctate urogenital fistulas, it is recommended to place a urethral catheter draining the upper urinary tract (urinary tract drainage via urethral catheter) or a ureteral stent (ureteral stenting), provided this stops urine leakage in order to promote fistula tract healing [11], [18].
GCR BLOE 3Grade of Recommendations B (Level of Evidence - 3)
Comments: Spontaneous closure of vesicovaginal fistulas with continuous urethral catheter drainage is rare. As a rule, this applies to small, so-called oblique fistulas. In some cases, prolonged ureteral drainage with a J-J ureteral stent can lead to the healing of a small defect. Bladder or ureteral drainage that does not stop urine leakage is impractical.
3.2 Pharmacotherapy
To date, there are no clear guidelines regarding the necessity of systemic antibacterial drugs for the prevention of urinary tract infections during the preoperative preparation period in patients with urogenital fistulas. Some authors suggest using broad-spectrum systemic antibacterial drugs, while others completely abandon antibiotic prophylaxis. During the period from diagnosis to surgery, it is necessary to ensure a normal quality of life for patients. Since the main symptom is involuntary urine leakage, wearing absorbent pads makes it possible to return to social life. Special attention should be paid to skin care in the vulva and perineal region, as "urinary" dermatitis frequently develops due to the toxic effect of urine on the skin. Sometimes local application of estrogens is advisable—their positive effect on tissues in postmenopausal women is empirically proven, although in patients with obstetric fistulas suffering from prolonged amenorrhea, their effect has not been proven. It is especially important to convince the patient of the necessity of high fluid intake—at least 2–3 liters per day. Most patients consciously restrict fluid intake in an attempt to reduce the amount of urine produced. However, a high concentration of salts and waste products adversely affects not only the tissues of the perineum and vagina, but also promotes the formation of urinary stones at the edges of the fistula. Ensuring adequate diuresis is the basis of preoperative preparation.
In the preoperative period, it is not recommended to prescribe antibacterial therapy for the prevention of urinary tract infections in female patients with urogenital fistulas [19], [20].
GCR ALOE 2Grade of Recommendations A (Level of Evidence - 2) Comments: the prescription of systemic antibacterial drugs is advisable only in the presence of urinary extravasation and urinoma formation. In patients with secondary (obstructive) acute pyelonephritis, antibacterial therapy is recommended to be initiated only after the obstruction is relieved and adequate urine outflow from the kidney is restored [21]. Prophylactic use of systemic antibacterial drugs does not improve the efficacy of fistuloplasty [20].
3.3 Surgical Treatment
There is no consensus in the literature regarding the optimal timing for fistuloplasty. The term "early fistuloplasty" used in various studies most commonly defines early intervention as occurring sooner than 3 months [22], [23].
Although relatively few studies have reported outcomes for both early and late fistuloplasty, overall, the efficacy of fistuloplasty did not differ significantly [21].
It is recommended to perform surgeries to repair urogenital fistulas (fistuloplasty) in female patients after the resolution of local inflammation and necrosis, and for radiation therapy-related fistulas, no earlier than 6 months after their onset to restore the integrity of the urinary system [24], [25], [26].
GCR CLEL 4Grade of Recommendation C (Level of Evidence - 4)
Comments: The timing of surgery is the most critical factor in the treatment of patients with urogenital fistulas. The main objective of the waiting period is to allow necrotic tissues to regenerate and local inflammation to resolve. This is particularly important in radiation-induced fistulas, where the preparatory period takes from 6 to 12 months. In surgical and obstetric fistulas, it is advisable to wait from 1.5 to 3 months, although some authors suggest performing surgery as soon as the fistula is cleared of necrotic tissue. In general, the time required to prepare patients for reconstructive surgery is determined based on the absence of significant proliferative and inflammatory processes in the tissues surrounding the fistula.
As the first stage of surgical treatment for patients with urogenital fistulas, it is recommended to remove necrotic tissue (necrectomy), postoperative sutures (ligatures), and urinary stones from the vagina and urinary bladder in order to eliminate inflammation [25], [27], [28].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comments: the removal of foreign bodies and necrotic tissue eliminates inflammation and shapes the fistula, which in turn creates the conditions for successful fistuloplasty [27].
It is recommended to perform urinary bladder drainage with prolonged urinary diversion in female patients with a fistula size not exceeding a few millimeters (pinpoint fistula) in order to achieve healing of the fistula tract [29].
Level of Recommendations CLevel of Evidence 3Level of Recommendation C (Level of Evidence – 3)
Comments: fulguration of the fistula tract enables conservative treatment of small-diameter fistulas (up to 4 mm) in female patients in whom epithelialization of the fistula tract is not complete.
It is recommended to perform vaginal fistuloplasty in patients with vesicovaginal fistulas in order to restore normal anatomy [18].
LeveL of Recommendation BGrade of Evidence 3LeveL of Recommendation B (Grade of Evidence - 3)
Comments: the vaginal approach in the surgical treatment of urogenital fistulas is the most minimally invasive and effective [30].
It is recommended to perform transabdominal fistuloplasty in patients with vesicovaginal fistulas and concomitant ureteral injuries in order to eliminate the fistula and simultaneously repair the ureteral injury [18].
LeveL of Recommendation BGrade of Evidence 3LeveL of Recommendation B (Grade of Evidence - 3)
Comments: transabdominal fistuloplasty can be performed via either a laparotomic or laparoscopic approach, including robot-assisted [31]. An indication for choosing the abdominal approach in fistula surgery is also a high location of the fistula. Cystoscopy and ureteral catheterization must be performed prior to surgery. During cystoscopy, a ureteral catheter or an indwelling balloon urethral catheter for drainage (Foley catheter) is inserted into the fistula tract and brought out through the vagina. Catheterization of the fistula helps to identify it during surgery.
It is recommended to perform transabdominal fistuloplasty in female patients with vesicovaginal fistulas and reduced bladder capacity in order to eliminate the fistula and simultaneously perform bladder augmentation [18], [28].
LeveL of Recommendation BGrade of Evidence 3LeveL of Recommendation B (Grade of Evidence - 3)
Comments: transabdominal fistuloplasty can be performed via either a laparotomic or laparoscopic approach, including robot-assisted [31]. Bladder augmentation is generally performed using the ileum.
It is recommended to perform vaginal fistuloplasty in female patients with urethrovaginal fistulas in order to restore normal anatomy [18].
LeveL of Recommendation BGrade of Evidence 3LeveL of Recommendation B (Grade of Evidence - 3)
Comments: Surgeries for the closure of urethrovaginal fistulas are performed exclusively via the vaginal approach. Due to tissue deficiency caused by the urethral wall defect, extensive tissue dissection is not performed. Following a circumscribing incision, the tissues of the vagina and urethra are mobilized. Stress urinary incontinence is the most common complication following urethrovaginal fistula reconstruction. Urinary incontinence is also more frequent after obstetric fistulas when the sphincter mechanism is involved, especially in the presence of tissue destruction. Urinary incontinence is diagnosed in half of female patients with urethrovaginal fistulas. It typically occurs when fistulas are localized in the proximal urethra or upon destruction of the bladder neck [9].
It is recommended for female patients with complex and recurrent fistulas to use tissue interposition during fistuloplasty to achieve airtight closure of the fistula [32].
GCR CLEL 4Grade of Recommendation C (Level of Evidence - 4)
Comments: In the presence of a complex fistula, standard vaginal surgery should be modified. Numerous techniques for the interposition of various tissue flaps have been described, which allow for the creation of an additional layer when there is tissue deficiency for closing the fistula tract.
The Martius flap (or fibro-adipose labial flap) was first described in the literature in 1928. The use of the Martius flap in the reconstruction of rectovaginal, vesicovaginal, and urethrovaginal fistulas significantly increases the success rate of the surgery. A peritoneal flap is used in the surgery of high fistulas, which most of the time form as a complication after hysterectomy. Mobilization of the Martius flap in this case can be difficult and may lead to significant vaginal shortening.
The peritoneal flap also has an excellent blood supply and can be easily adapted for mobilization into the area of the fistula tract. Omental interposition is generally used in the abdominal approach for urogenital fistula surgery, however, this flap can also be used in transvaginal surgery in women who have recurrent fistulas and have previously undergone fistula closure procedures. The essence of the surgery is to form a flap from the omentum and transpose it into the area between the urinary bladder and the vaginal wall to create an additional layer. The use of a gluteal skin flap is mainly indicated for patients with radiation fistulas or significantly pronounced vaginal wall atrophy when other nearby tissues cannot be used [33].
Patients with ureterovaginal fistulas are recommended urinary tract stenting (ureteral stenting), if the ureter is patent, in order to promote fistula healing [24], [34].
GPP CLeE 5Strong recommendation grade C (level of evidence - 5)
Comments: If intraoperative ureteral injury is identified, an urgent consultation with a urologist is necessary to immediately restore the patency of the upper urinary tract and prevent the development of complications. At the same time, relative contraindications to the immediate restoration of the integrity and patency of the upper urinary tract include sepsis, hemodynamic instability, and the presence of coagulopathy in the patient. In case of intraoperative recognition of accidental ureteral ligation, the ligature must be removed immediately. If ureteral peristalsis is preserved upon examination of the ureter and the trauma appears minimal, it is possible to omit additional manipulations and limit management to active postoperative surveillance [34].
If revision of the ureter reveals a partial transection of its wall or if ischemic changes are suspected, placement of an internal ureteral stent is indicated [21], [35].
Regardless of the type of ureteral injury inflicted, urgent measures must be taken. If there is obstruction, as well as intraperitoneal or retroperitoneal urine leakage, measures for urinary diversion must be taken immediately. It is important to understand that the higher the degree of obstruction, the lower the probability of retrograde ureteral stenting. In cases where retrograde renal stenting is impossible, percutaneous nephrostomy must be performed immediately. Any delay in relieving the obstruction can lead to a decrease in renal function.
It is recommended to perform ureteral reimplantation in patients with ureterovaginal fistulas to restore urinary drainage from the kidney [36].
LeRR CLoE 4Level of recommendation confidence C (level of evidence – 4)
Comments: When ureteral injury is localized below the crossing with the common iliac vessels, ureteral reimplantation is technically very difficult to perform. In such a situation, Boari flap reimplantation or a psoas-hitch is performed. During this surgery, the urinary bladder is mobilized, and a flap is fashioned from its wall to substitute for the part of the ureter located distal to the injury site. Reimplantation is contraindicated in patients with a history of external beam radiation therapy to the pelvic organs, bladder cancer, and any conditions accompanied by thickening or hypertrophy of the bladder wall.
When the ureteral injury is localized below the crossing with the common iliac vessels, where its visualization is difficult, performing a ureteroureterostomy is usually too challenging. In this case, as well as in extensive injury to the pelvic ureter, performing reimplantation using one technique or another is indicated [37].
Patients with reduced bladder capacity and large fistula size are recommended intestinal urinary diversion to eliminate involuntary urine leakage [28], [38].
GPP CLeE 4Strong recommendation grade C (level of evidence - 4) Comments: intestinal urinary diversion may consist in the creation of a heterotopic or orthotopic intestinal urinary reservoir.
3.4. Diet therapy
Not provided
3.5. Pain management
Not applicable
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Methods of medical rehabilitation for patients with urogenital fistulas are not provided.
5. Prevention and Dispensary Observation
It is not recommended to perform ureteral catheterization in patients during genital surgeries for the purpose of preventing injury [1], [39].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
6. Organization of Medical Care
Indications for elective hospitalization:
1. Examination of the fistula under anesthesia for radiation fistulas
2. Surgical treatment of urogenital fistulas
3. Removal of urinary tract drains and catheters;
Indications for emergency hospitalization:
1. urinary tract urodynamic impairment requiring surgical treatment;
Indications for discharging the patient from the hospital:
1. closure of the urogenital fistula;
2. absence of upper urinary tract urodynamic impairment.
7. Additional Information
The presence of risk factors in patients with urogenital fistulas (smoking, diabetes mellitus, radiation exposure) can lead to disease recurrence.
A fistula size greater than 3 cm and prior vaginal surgeries increase the risk of disease recurrence [10].
Following fistuloplasty, 48% of female patients who suffered from urethrovaginal fistulas experience urinary incontinence [9].
The use of tissue flaps in the surgical treatment of radiation fistulas reduces the likelihood of recurrence [24].
Criteria for Evaluating the Quality of Medical Care
No. | Quality criterion | Performance |
|---|---|---|
1. | A physical examination of the patient was performed for the purpose of diagnosis verification | yes/no |
2. | A renal ultrasound was performed to rule out upper urinary tract obstruction | yes/no |
3. | Fistuloplasty was performed with restoration of the integrity of the urinary system | yes/no |
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Appendix A1. Working Group Composition
Dmitry Yu. Pushkar – MD, Professor, Academician of the Russian Academy of Sciences, Head of the Department of Urology, A.I. Evdokimov Moscow State University of Medicine and Dentistry. Chief Freelance Urologist of the Russian Ministry of Health.
Leila V. Adamyan – Academician of the Russian Academy of Sciences, MD, Professor, Deputy Director of the V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Ministry of Health of the Russian Federation, Honored Scientist of Russia, Head of the Department of Reproductive Medicine and Surgery, A.I. Evdokimov Moscow State University of Medicine and Dentistry of the Russian Ministry of Health, Chief Specialist of the Ministry of Health of the Russian Federation in Obstetrics and Gynecology, member of the Society for Reproductive Medicine and Surgery, the Russian Association of Endoscopic Gynecologists, the Russian Association for Endometriosis, and the Russian Society of Obstetricians and Gynecologists.
Gevorg R. Kasyan — Doctor of Medical Sciences, Professor at the Department of Urology, A.I. Evdokimov Moscow State University of Medicine and Dentistry.
Conflict of interest: All Working Group members have confirmed the absence of financial support / conflicts of interest that need to be disclosed.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines: specialists with higher medical education in the following specialties:
1. Urology
2. Obstetrics and gynecology.
3. Surgery
In these clinical guidelines, all data are ranked by level of reliability (evidence) depending on the quantity and quality of studies on the issue.
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 review of randomized clinical trials with meta-analysis |
2 | Individual studies with reference standard 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 reports |
5 | Rationale based solely on mechanism of action or expert opinion |
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 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 |
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 evaluated criteria of effectiveness (outcomes) are important, all studies have high or satisfactory methodological quality, and their conclusions regarding the outcomes of interest are consistent) |
B | Conditional recommendation (not all evaluated criteria of effectiveness (outcomes) are important, not all studies have high or satisfactory methodological quality, and/or their conclusions regarding the outcomes of interest are inconsistent) |
C | Weak recommendation (lack of adequate quality evidence (all evaluated criteria of effectiveness (outcomes) are unimportant, all studies have low methodological quality and their conclusions regarding the outcomes of interest are inconsistent) |
Appendix A3. Reference Materials
References to regulatory acts
Order of the Russian Ministry of Health No. 907n dated November 12, 2012, "On Approval of the Rules for the Provision of Medical Care to the Adult Population Profile 'Urology'."
Order of the Ministry of Health of the Russian Federation No. 1130n dated October 20, 2020, "On Approval of the Rules for the Provision of Medical Care Profile 'Obstetrics and Gynecology'"
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
Urogenital fistulas may result from complications of obstetric and surgical interventions, radiation therapy, oncological diseases, and injuries of the urogenital organs. The same factors can cause the formation of enterourogenital fistulas, along with inflammatory bowel diseases. It is important to remember that most such fistulas form as a result of altered pelvic anatomy due to ovarian tumors, adhesions between the bladder and the uterus or cervix caused by previous surgeries in this area, endometriosis, and infectious complications. Naturally, surgical technique details are also of great importance. Treatment of urogenital fistulas is predominantly surgical. The success rate of fistula closure exceeds 90%; however, for radiation fistulas and fistulas larger than 3 cm, it is significantly lower.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
No.