Diagnosis and Therapy of Female Urinary Incontinence. Guideline of the DGGG, OEGGG and SGGG (S2k Level, AWMF Registry No. 015/091, January 2022)

Abstract

Aim This completely revised interdisciplinary S2k-guideline on the diagnosis, therapy, and follow-up care of female patients with urinary incontinence (AWMF registry number: 015-091) was published in December 2021. This guideline combines and summarizes earlier guidelines such as “Female stress urinary incontinence,” “Female urge incontinence” and “Use of Ultrasonography in Urogynecological Diagnostics” for the first time. The guideline was coordinated by the German Society for Gynecology and Obstetrics (Deutsche Gesellschaft für Gynäkologie und Geburtshilfe, DGGG) and the Working Group for Urogynecology and Plastic Pelvic Floor Reconstruction (Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V., AGUB).

Methods This S2k-guideline was developed using a structured consensus process involving representative members from different medical specialties and was commissioned by the Guidelines Commission of the DGGG, OEGGG and SGGG. The guideline is based on the current version of the guideline “Urinary Incontinence in Adults” published by the European Association of Urology (EAU). Country-specific items associated with the respective healthcare systems in Germany, Austria and Switzerland were also incorporated.

Recommendations The short version of this guideline consists of recommendations and statements on the surgical treatment of female patients with stress urinary incontinence and urge incontinence. Specific solutions for the diagnostic workup and treatment of uncomplicated and complicated urinary incontinence are discussed. The diagnostics and surgical treatment of iatrogenic urogenital fistula are presented.

Key words

guideline - urinary incontinence - stress urinary incontinence - urge urinary incontinence - surgical therapy - suburethral sling - colposuspension - urogenital fistula

I  Guideline Information

Guidelines program of the DGGG, OEGGG and SGGG

For information on the guidelines program, please refer to the end of the guideline.

Citation format

Diagnosis and Therapy of Female Urinary Incontinence. Guideline of the DGGG, OEGGG and SGGG (S2k Level, AWMF Registry No. 015/091, January 2022). Part 2 with Recommendations on Interventional/Surgical Therapy of Overactive Bladder, Surgical Treatment of Stress Urinary Incontinence and Diagnosis and Therapy of Iatrogenic Urogenital Fistula. Geburtsh Frauenheilk 2023. doi:10.1055/a-1967-1888

Guideline documents

The complete long version in German and a slide version of this guideline as well as a list of the conflicts of interest of all the authors are available on the homepage of the AWMF: http://www.awmf.org/leitlinien/detail/ll/015-091.html

Guideline authors

See [Tables 1] and [2].

Table 1 Lead and/or coordinating guideline author.

Author	AWMF professional society
Prof. Dr. med. Christl Reisenauer	German Society for Gynecology and Obstetrics (Deutsche Gesellschaft für Gynäkologie und Geburtshilfe [DGGG])
Priv. Doz. Dr. med. habil. Gert Naumann	Deutsche Gesellschaft für Gynäkologie und Geburtshilfe (DGGG)

Table 2 Contributing guideline authors.

Author Mandate holder	DGGG working group (AG)/AWMF/non-AWMF professional society/organization/association
PD Dr. med. Thomas Aigmüller	Austrian Urogynecology Working Group for Reconstructive Pelvic Floor Surgery (Österreichische Arbeitsgemeinschaft für Urogynäkologie und rekonstruktive Beckenbodenchirurgie [AUB])
Prof. Dr. med. Werner Bader	German Society of Ultrasound in Medicine and Biology (Deutsche Gesellschaft für Ultraschall in der Medizin [DEGUM])
Prof. Dr. med. Ricarda Bauer	German Society of Urology (Deutsche Gesellschaft für Urologie [DGU])
Dr. med. Kathrin Beilecke	Working Group for Urogynecology and Plastic Pelvic Floor Reconstruction of the DGGG (Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V. [AGUB] der DGGG)
PD Dr. med. Cornelia Betschart	Swiss Society of Gynecology and Obstetrics (Schweizerische Gesellschaft für Gynäkologie und Geburtshilfe [SGGG]) Swiss Working Group for Urogynecology and Pelvic Floor Pathology (Schweizer Arbeitsgemeinschaft Urogynäkologie und Beckenbodenpathologie [AUG])
Dr. med. Gunther Bruer	Federal Association of Gynecologists (Bundesverband der Frauenärzte)
Prof. Dr. med. Dr. phil. Thomas Bschleipfer	German Society for Urology (Deutsche Gesellschaft für Urologie [DGU])
PD Dr. med. Miriam Deniz	Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V. (AGUB) der DGGG
Dr. med. Thomas Fink	Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V. (AGUB) der DGGG
Prof. Dr. med. Boris Gabriel	Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V. (AGUB) der DGGG
Roswitha Gräble	Patient representative
Prof. Dr. med. Matthias Grothoff	Radiology expert
Prof. Dr. med. Axel Haferkamp	German Continence Society (Deutsche Kontinenz-Gesellschaft)
Prof. Dr. med. Christian Hampel	Deutsche Gesellschaft für Urologie (DGU)
Ulla Henscher	Gynecology, Obstetrics, Urology, Proctology Working Group of the German Association for Physiotherapy (Arbeitsgemeinschaft für Gynäkologie Geburtshilfe Urologie Proktologie [AG-GGUP] im Deutschen Verband für Physiotherapie [ZVK])
Prof. Dr. med. Markus Hübner	Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V. (AGUB) der DGGG
Dr. med. Hansjoerg Huemer	Schweizer Arbeitsgemeinschaft Urogynäkologie und Beckenbodenpathologie (AUG)
PD Dr. med. Jacek Kociszewski	Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V. (AGUB) der DGGG
Prof. Dr. med. Dr. h. c. Heinz Kölbl	Österreichische Arbeitsgemeinschaft für Urogynäkologie und rekonstruktive Beckenbodenchirurgie (AUB)
Dr. med. Dieter Kölle	Österreichische Arbeitsgemeinschaft für Urogynäkologie und rekonstruktive Beckenbodenchirurgie (AUB)
Dr. med. Stephan Kropshofer	Österreichische Arbeitsgemeinschaft für Urogynäkologie und rekonstruktive Beckenbodenchirurgie (AUB)
Prof. Dr. med. Annette Kuhn	Schweizer Arbeitsgemeinschaft Urogynäkologie und Beckenbodenpathologie (AUG)
PD Dr. med. Gert Naumann	Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V. (AGUB) der DGGG
Prof. Dr. med. Dr. phil. Matthias Oelke	Deutsche Gesellschaft für Urologie (DGU)
Prof. Dr. med. Ursula Peschers	Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V. (AGUB) der DGGG
Dr. med. Oliver Preyer	Österreichische Arbeitsgemeinschaft für Urogynäkologie und rekonstruktive Beckenbodenchirurgie (AUB)
Prof. Dr. med. Christl Reisenauer	Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V. (AGUB) der DGGG
Prof. Dr. med. Daniela Schultz-Lampel	Deutsche Gesellschaft für Urologie (DGU)
Prof. Dr. med. Karl Tamussino	Austrian Society for Gynecology and Obstetrics (Österreichische Gesellschaft für Gynäkologie und Geburtshilfe [OEGGG]) Österreichische Arbeitsgemeinschaft für Urogynäkologie und rekonstruktive Beckenbodenchirurgie (AUB)
Reina Tholen	Arbeitsgemeinschaft für Gynäkologie Geburtshilfe Urologie Proktologie (AG-GGUP) im Deutschen Verband für Physiotherapie (ZVK)
Prof. Dr. med. Ralf Tunn	Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V. (AGUB) der DGGG
Prof. Dr. med. Volker Viereck	Schweizer Arbeitsgemeinschaft Urogynäkologie und Beckenbodenpathologie (AUG)

The following professional societies/working groups/organizations/associations stated that they wished to contribute to the guideline text and participate in the consensus conference and nominated representatives to contribute and attend the conference ([Table 2]).

The guideline was moderated by Dr. Monika Nothacker (AWMF-certified guideline consultant/moderator).

II  Guideline Application

Purpose and objectives

The guideline “Female Urinary Incontinence” represents a summary of the current state of knowledge as well as a formal consensus of experts on diagnostics and therapeutic options and should serve as general orientation for physicians treating these patients.

Target areas of care

This guideline covers the whole range of diagnostics, treatment, and follow-up care of female patients with urinary incontinence and was developed for both outpatient and inpatient care. The information on diagnostics and treatment of urinary incontinence should be of interest both for chief physicians and medical specialists.

Target user groups/target audience

This guideline covers the treatment given to adult women and is aimed at all physicians and professionals involved in outpatient and/or inpatient care or the rehabilitation of female patients with urinary incontinence.

Adoption and period of validity

The validity of this guideline was confirmed by the executive boards/representatives of the participating medical professional societies/working groups/organizations/associations as well as by the boards of the DGGG, SGGG and OEGGG as well as by the DGGG/OEGGG/SGGG Guidelines Commission in December 2021 and was thereby approved in its entirety. This guideline is valid from 1 January 2022 through to 31 January 2024. Because of the contents of this guideline, this period of validity is only an estimate. The guideline can be reviewed and updated earlier if necessary. If the guideline still reflects the current state of knowledge, its period of validity can be extended.

III  Methodology

Basic principles

The method used to prepare this guideline was determined by the class to which this guideline was assigned. The AWMF Guidance Manual (version 1.0) has set out the respective rules and requirements for different classes of guidelines. Guidelines are differentiated into lowest (S1), intermediate (S2), and highest (S3) class. The lowest class is defined as consisting of a set of recommendations for action compiled by a non-representative group of experts. In 2004, the S2 class was divided into two subclasses: a systematic evidence-based subclass (S2e) and a structural consensus-based subclass (S2k). The highest S3 class combines both approaches.

This guideline was classified as: S2k

Grading of recommendations

The grading of evidence based on the systematic search, selection, evaluation, and synthesis of an evidence base which is then used to grade the recommendations is not envisaged for S2k guidelines. The various individual statements and recommendations are only differentiated by syntax, not by symbols ([Table 3]):

Table 3 Grading of recommendations (based on Lomotan et al., Qual Saf Health Care 2010).

Description of binding character	Expression
Strong recommendation with highly binding character	must/must not
Regular recommendation with moderately binding character	should/should not
Open recommendation with limited binding character	may/may not

Statements

Expositions or explanations of specific facts, circumstances, or problems without any direct recommendations for action included in this guideline are referred to as “statements.” It is not possible to provide any information about the level of evidence for these statements.

Achieving consensus and level of consensus

At structured NIH-type consensus-based conferences (S2k/S3 level), authorized participants attending the session vote on draft statements and recommendations. The process is as follows. A recommendation is presented, its contents are discussed, proposed changes are put forward, and all proposed changes are voted on. If a consensus (> 75% of votes) is not achieved, there is another round of discussions, followed by a repeat vote. Finally, the extent of consensus is determined, based on the number of participants ([Table 4]).

Table 4 Level of consensus based on extent of agreement.

Symbol	Level of consensus	Extent of agreement in percent
+++	Strong consensus	> 95% of participants agree
++	Consensus	> 75 – 95% of participants agree
+	Majority agreement	> 50 – 75% of participants agree
–	No consensus	< 51% of participants agree

Expert consensus

As the term already indicates, this refers to consensus decisions taken specifically relating to recommendations/statements issued without a prior systematic search of the literature (S2k) or where evidence is lacking (S2e/S3). The term “expert consensus” (EC) used here is synonymous with terms used in other guidelines such as “good clinical practice” (GCP) or “clinical consensus point” (CCP). The strength of the recommendation is graded as previously described in the chapter Grading of recommendations but without the use of symbols; it is only expressed semantically (“must”/“must not” or “should”/“should not” or “may”/“may not”).

IV  Guideline

1  Interventional/surgical therapy of overactive bladder

Surgical treatment of OAB is indicated when conservative treatment and drug therapies have not resulted in the desired success even after adequate duration of conservative/drug therapy or therapy must be discontinued due to intolerable side effects.

1.1  Injection of onabotulinum toxin A into the bladder

Injections of onabotulinum toxin A into the bladder wall are an effective, minimally invasive, surgical therapy for treatment-resistant overactive bladder. They significantly reduce the number of episodes of incontinence and urge incontinence as well as the micturition frequency during the day and at night and lead to an overall improvement in the patientʼs quality of life.

Only onabotulinum toxin A has been approved worldwide for the surgical therapy of overactive bladder. The approved dosage is 100 units (U) of onabotulinum toxin A, which is first diluted in an NaCl solution before being injected endoscopically into the bladder wall (10 ml NaCl solution, 20 injections).

Consensus-based recommendation E6-01
Expert consensus	Level of consensus ++
Onabotulinum toxin A (100 U) injections should be offered to patients if conservative and oral drug therapy have not led to the desired success even after adequate duration of therapy (recommendation).

Consensus-based recommendation E6-02
Expert consensus	Level of consensus ++
Patients must be informed that the effect of onabotulinum toxin A will only persist for a limited time as well as about the post-intervention risk of urinary tract infections and residual urine, possibly requiring intermittent (self) catheterization (strong recommendation).

1.2  Electric neuromodulation

Sacral neuromodulation (SNM) or percutaneous tibial nerve stimulation (PTNS) are used to treat overactive bladder by amending the imbalance between the stimulating and inhibitory control systems of the bladder through directly or indirectly influencing the function of the afferent bladder nerves. The advantages and disadvantages of botulinum toxin injections and of sacral neuromodulation are listed in [Table 5].

Table 5 Advantages and disadvantages of botulinumtoxin A injections vs. sacral neuromodulation.

	Botulinumtoxin A	Sacral neuromodulation
For	simple and quick administration rapid onset of action no “surgical” intervention required	long-lasting effect (years) additional positive effect on fecal incontinence and sexual function disorders
Against	limited duration of action (months), therefore requires regular re-injections risk of residual urine, ISC, UTI	surgery (2 ×) test phase requires active cooperation on the part of the patient implant patient may have an aversion to the technology revision surgery requires long-term follow-up care can only be carried out in centers with the required expertise

Sacral neuromodulation (SNM)

Consensus-based recommendation E6-03
Expert consensus	Level of consensus ++
Sacral neuromodulation should be offered to female patients with overactive bladder if conservative and oral drug therapies have not led to the desired success even after adequate duration of therapy (recommendation).

Consensus-based recommendation E6-04
Expert consensus	Level of consensus ++
The sacral neurostimulator should be switched off during pregnancy and birth (recommendation).

Consensus-based recommendation E6-05
Expert consensus	Level of consensus +++
Sacral neuromodulation may be considered to treat female patients with overactive bladder and concurrent sexual dysfunction or fecal incontinence as it would simultaneously treat the other functional disturbances (open recommendation).

Posterior tibial nerve stimulation (PTNS)

Consensus-based recommendation E6-06
Expert consensus	Level of consensus ++
PTNS should be offered to female patients with overactive bladder as a treatment option if conservative and oral drug therapies have not led to the desired success even after adequate duration of therapy (recommendation).

Consensus-based recommendation E6-07
Expert consensus	Level of consensus +++
The option to offer PTNS also to patients with overactive bladder and concurrent sexual dysfunction or fecal incontinence may be considered (open recommendation).

1.3  Bladder augmentation/urinary diversion

The now widespread use of onabotulinum toxin injections into the bladder wall and the increasing use of sacral neuromodulation have meant that significantly fewer bladder augmentations or urinary diversions have been indicated in recent years.

Consensus-based recommendation E6-08
Expert consensus	Level of consensus ++
Bladder augmentation or urinary diversion to treat female patients with overactive bladder may be offered in selected cases if other treatment methods have failed (open recommendation).

Consensus-based recommendation E6-09
Expert consensus	Level of consensus +++
Detrusor myectomy to treat urinary incontinence must not be offered to patients (strong recommendation).

1.4  Surgical apical fixation to treat overactive bladder

Consensus-based recommendation E6-10
Expert consensus	Level of consensus +++
Because the data is still insufficient, surgical apical fixation to treat overactive bladder should only be carried out in cases with grade 0 – 1 apical prolapse (according to the POP-Q classification system) in the context of prospective studies (recommendation).

2  Surgical therapy of stress urinary incontinence

Surgical therapy to treat stress urinary incontinence should only be considered after having exhausted conservative treatment options.

2.1  Surgical therapy of uncomplicated stress urinary incontinence

Uncomplicated stress urinary incontinence is present if the patient does not have a previous history of incontinence surgery, has no neurological symptoms and no symptomatic pelvic organ/uterine prolapse and the patient does not wish to bear children. Complicated stress urinary incontinence is present if women meet one or more of the above-listed criteria.

Open and laparoscopic colposuspension

Laparoscopic colposuspension has shown to have the same high level of effectiveness to heal stress urinary incontinence as open colposuspension for up to two years postoperatively.

Open and laparoscopic colposuspension versus suburethral tape

Systematic Cochrane reviews found no difference in continence levels or improvements in incontinence between open or laparoscopic colposuspension and suburethral tape procedures.

Consensus-based statement S7-01
Expert consensus	Level of consensus +++
In cases with uncomplicated stress urinary incontinence, colposuspension results in similar objective and subjective success rates as suburethral tension-free tape.

Consensus-based statement S7-02
Expert consensus	Level of consensus ++
Colposuspension is associated with a higher long-term risk of posterior compartment prolapse compared to suburethral tension-free tape.

Consensus-based statement S7-03
Expert consensus	Level of consensus ++
Laparoscopic colposuspension is less invasive than open colposuspension and results in similar continence rates with shorter convalescence times.

Consensus-based statement S7-04
Expert consensus	Level of consensus +++
Colposuspension can elevate and stabilize the bladder neck in cases with significant bladder neck descent and greater rotation of the urethra, significant funneling or lateral defect.

Fascial sling

Consensus-based statement S7-05
Expert consensus	Level of consensus +++
Autologous fascial sling (AFS) procedures to treat female stress incontinence have similar subjective and objective success rates as synthetic suburethral tape. Synthetic tapes have lower complication rates and require a shorter operating time.

Consensus-based statement S7-06
Expert consensus	Level of consensus +++
Autologous fascial sling procedures at the bladder neck may be considered in patients with hypotonic urethra, a high risk of tape erosion or following failure of a suburethral tape procedure.

Tension-free suburethral tape

Long-term outcomes of mid-urethral tape procedures

Consensus-based statement S7-07
Expert consensus	Level of consensus +++
Long-term data have shown long-lasting success rates for suburethral tape procedures with a follow-up (FU) of 10 years and more.

Consensus-based statement S7-08
Expert consensus	Level of consensus +++
The retropubic and transobturator implantation techniques for suburethral tapes are comparable with respect to their 5-year effectivity rate.

Consensus-based statement S7-09
Expert consensus	Level of consensus +++
Retropubic suburethral tapes have been shown to have a higher objective healing rate over a follow-up period of 8 years.

Consensus-based statement S7-10
Expert consensus	Level of consensus +++
The retropubic tape technique is associated with a higher risk of bladder perforation and bladder voiding disorders compared to the transobturator technique.

Consensus-based statement S7-11
Expert consensus	Level of consensus +++
Pain in the groin/inner thigh area and vaginal sulcus perforation are more common after placement of a transobturator tape.

Urinary stress incontinence surgery for special patient groups

Obese female patients

Studies of retropubic and transobturator tape procedures performed in normal-weight and overweight women have found them to be similarly effective.

Studies have confirmed that losing weight has a positive effect on reducing the incidence of incontinence events.

Consensus-based statement S7-12
Expert consensus	Level of consensus +++
Obese patients can also benefit from urinary incontinence procedures.

Older female patients (> 65 years)

Consensus-based statement S7-13
Expert consensus	Level of consensus +++
Good success rates and low complication rates can also be achieved in older patients following suburethral tape procedures; however, the risk of surgical failure appears to increase with increasing age.

Single-incision sling (“mini sling”)

Single-incision sling procedures have been shown to have a similarly high stress urinary incontinence healing rate as retropubic or transobturator tapes for up to 12 months postoperatively. This equivalence has not yet been demonstrated for longer follow-up periods.

Consensus-based statement S7-14
Expert consensus	Level of consensus +++
There is no evidence that the outcomes of single-incision sling procedures are equivalent to those of conventional suburethral tapes for follow-up periods of more than 12 months.

Consensus-based statement S7-15
Expert consensus	Level of consensus +++
Immediate postoperative pain in the thigh area is lower after single-incision tape procedures compared to transobturator tape procedures.

Consensus-based statement S7-16
Expert consensus	Level of consensus +++
There are no long-term data showing that other side effects or complications following single-incision tape procedures are rarer or more common than after placement of other suburethral tapes.

Consensus-based statement S7-17
Expert consensus	Level of consensus ++
Sexual function appears to improve more after single-incision tape procedures than after other suburethral tape procedures.

Adjustable slings

Consensus-based statement S7-18
Expert consensus	Level of consensus ++
There is no evidence showing that an adjustable sling offers superior outcomes to a standard sling.

Consensus-based statement S7-19
Expert consensus	Level of consensus ++
We do not recommend implanting an adjustable sling to treat uncomplicated stress urinary incontinence.

Bulking agents

Clinical experience has shown that this procedure is particularly suitable for female patients with hypotonic or immobile (frozen) urethra, e.g., following colposuspension, for whom a suburethral tape procedure is not a suitable surgical option.

Consensus-based statement S7-20
Expert consensus	Level of consensus +++
A single transurethral submucosal injection of a bulking agent may result in short-term improvement or healing (for up to 12 months) in female patients with stress urinary incontinence.

Consensus-based statement S7-21
Expert consensus	Level of consensus +++
Bulking agents are not as effective to heal stress urinary incontinence as colposuspension, autologous fascial sling or suburethral tape procedures.

Consensus-based statement S7-22
Expert consensus	Level of consensus +++
Bulking agents have the lowest surgery-related morbidity rates of all invasive treatment options.

Consensus-based recommendation E7-01
Expert consensus	Level of consensus +++
Bulking agents may be offered to female patients with stress urinary incontinence after the patient has been informed about their lower effectivity compared to suburethral tape procedures and the potential necessity of having a repeat injection (open recommendation).

Consensus-based recommendation E7-02
Expert consensus	Level of consensus ++
Because of the low morbidity rate, bulking agents may be especially offered to female patients with a higher surgical risk (open recommendation).

2.2  Surgical therapy of complicated stress urinary incontinence (recurrent incontinence)

The failure rate after incontinence surgery varies greatly and depends on the definition of surgical failure. Failure may occur immediately postoperatively (persistent incontinence) or years after the operation (recurrent incontinence).

Consensus-based statement S7-23
Expert consensus	Level of consensus ++
Most operative procedures carried out in cases with recurrence are less likely to have a promising outcome.

Artificial urethral sphincter (AUS)

Consensus-based statement S7-24
Expert consensus	Level of consensus +++
The implantation of an artificial urethral sphincter may improve or heal stress urinary incontinence caused by urethral insufficiency.

Consensus-based statement S7-25
Expert consensus	Level of consensus +++
Complications, mechanical failure and explantation are relatively common after implantation of an artificial urethral sphincter.

Consensus-based statement S7-26
Expert consensus	Level of consensus +++
Explantation rates are higher in geriatric patients and after surgical colposuspension or pelvic radiotherapy.

2.3  Surgical therapy of stress urinary incontinence in women with mixed urinary incontinence

Consensus-based statement S7-27
Expert consensus	Level of consensus +++
Women with mixed urinary incontinence are less likely to experience healing of their incontinence following a procedure than women who only have stress urinary incontinence.

Consensus-based statement S7-28
Expert consensus	Level of consensus ++
The development of urge symptoms after surgery for stress urinary incontinence cannot be predicted with any certainty.

2.4  Surgical therapy of urinary incontinence in women with urogenital prolapse

There is a clear association between incontinence and urogenital prolapse. Based on current studies, it is difficult to judge whether concurrent prolapse and incontinence surgery reduces the incidence of de novo stress urinary incontinence. Studies in which suburethral tapes were placed have shown better results compared to other surgical incontinence procedures. The patientʼs individual circumstances clearly play an important role when planning surgery. It is important to be aware that, although more women are continent postoperatively if they have undergone combined surgery, the risk of requiring repeat surgery is higher.

Women with both prolapse and manifest stress urinary incontinence

Consensus-based statement S7-29
Expert consensus	Level of consensus ++
Women with stress urinary incontinence and prolapse have a higher healing rate of stress urinary incontinence following concurrent surgery for prolapse and incontinence.

Consensus-based statement S7-30
Expert consensus	Level of consensus +++
Combined prolapse surgery and incontinence procedures have more side effects than prolapse surgery performed alone.

Continent women with prolapse

Consensus-based statement S7-31
Expert consensus	Level of consensus +++
Continent women with prolapse are at risk of suffering from urinary incontinence postoperatively.

Consensus-based statement S7-32
Expert consensus	Level of consensus ++
An additional prophylactic continence procedure may reduce the risk of postoperative urinary incontinence.

Consensus-based statement S7-33
Expert consensus	Level of consensus +++
An additional prophylactic continence procedure increases the risk of complications (particularly of overcorrection).

Women with prolapse and overactive bladder

Consensus-based statement S7-34
Expert consensus	Level of consensus +++
There is evidence that prolapse surgery may improve the symptoms of overactive bladder.

2.5  Summary

Recommendations for surgical therapy for uncomplicated female stress urinary incontinence

Consensus-based recommendation E7-03
Expert consensus	Level of consensus ++
Suburethral (retropubic or transobturator) tape placement must be offered to women with uncomplicated stress urinary incontinence as the primary surgical therapeutic option (strong recommendation).

Consensus-based recommendation E7-04
Expert consensus	Level of consensus +++
Open or laparoscopic colposuspension or autologous fascial sling procedures must be offered to women with stress urinary incontinence if suburethral (retropubic or transobturator) tape placement has been ruled out. Colposuspension may also be appropriate in cases with concurrent traction cystocele or if a laparoscopic/open approach was already selected for other reasons (strong recommendation).

Consensus-based recommendation E7-05
Expert consensus	Level of consensus +++
Laparoscopic colposuspension should be chosen (if the surgeon has the required expertise) in preference to open colposuspension. It is associated with a shorter hospital stay than open procedures and is equally effective (recommendation).

Consensus-based recommendation E7-06
Expert consensus	Level of consensus +++
Female patients who are offered colposuspension must be informed about the longer operating time and convalescence time, the longer stay in hospital and the higher risk of postoperative bladder voiding disorders and urogenital prolapse (particularly rectoceles) (strong recommendation).

Consensus-based recommendation E7-07
Expert consensus	Level of consensus ++
Female patients with stress urinary incontinence who are offered placement of a retropubic sling must be informed about the higher perioperative risk of complications compared to placement of a transobturator sling (strong recommendation).

Consensus-based recommendation E7-08
Expert consensus	Level of consensus ++
Female patients with stress urinary incontinence who are offered placement of a transobturator sling must be informed about the higher long-term risk of dyspareunia and pain (strong recommendation).

Consensus-based recommendation E7-09
Expert consensus	Level of consensus ++
Autologous fascial sling procedures performed by experienced surgeons may have a higher success rate than Burch colposuspension. Female patients with stress urinary incontinence who are treated with autologous fascial sling must be informed about the high risk of intraoperative complications, particularly of postoperative bladder voiding disorders and postoperative urinary tract infections along with the potential necessity of intermittent self-catheterization; it is important to ensure that they are both capable of doing so and will agree to do so (open recommendation).

Consensus-based recommendation E7-10
Expert consensus	Level of consensus +++
Intraoperative urethrocystoscopy must be carried out during every placement of a retropubic suburethral tape and, if any difficulties occur, during placement of a suburethral transobturator tape (strong recommendation).

Consensus-based recommendation E7-11
Expert consensus	Level of consensus +++
Female patients with stress urinary incontinence who are offered a mini sling (single-incision tape) should be informed that this procedure could be less effective than placement of a standard suburethral sling and that it is not yet clear whether this procedure is effective for more than one year (recommendation).

Consensus-based recommendation E7-12
Expert consensus	Level of consensus +++
Periurethral bulking agents may be offered to women who want to have a very low risk procedure and who understand that repeat injections may be necessary (open recommendation).

Recommendations for the surgical therapy of complicated female stress urinary incontinence

Consensus-based recommendation E7-13
Expert consensus	Level of consensus +++
The surgical therapy for complicated stress urinary incontinence should be chosen based on the patientʼs individual circumstances and condition after carrying out urodynamic and imaging (ultrasound) investigations (recommendation).

Consensus-based recommendation E7-14
Expert consensus	Level of consensus +++
Female patients must be informed that the surgical success of a repeat procedure is lower than that of primary therapy, both in terms of a lower benefit and a higher risk of complications (strong recommendation).

Consensus-based recommendation E7-15
Expert consensus	Level of consensus +++
In principle, all procedures which are used in primary therapy can be used to treat complicated stress urinary incontinence. It should be assessed whether repeat placement of a suburethral tape, colposuspension or fascial sling procedure or AUS implantation would be advisable (recommendation).

Consensus-based recommendation E7-16
Expert consensus	Level of consensus +++
Implantation of an AUS should be carried out in specialized centers (recommendation).

Consensus-based recommendation E7-17
Expert consensus	Level of consensus +++
The symptom subjectively experienced by the patient as the main symptom should be treated primarily in cases with mixed urinary incontinence (recommendation).

Consensus-based recommendation E7-18
Expert consensus	Level of consensus +++
Women must be informed that surgical procedures are less likely to be successful to treat mixed urinary incontinence than to treat cases who only have stress urinary incontinence and that a single therapeutic measure may not be sufficient to treat mixed urinary incontinence (strong recommendation).

Recommendations for the surgical therapy of symptomatic stress urinary incontinence and prolapse

Consensus-based recommendation E7-19
Expert consensus	Level of consensus ++
A concurrent prolapse and incontinence procedure may be offered to patients. A two-stage approach is possible (open recommendation).

Recommendations for female patients with asymptomatic or masked stress urinary incontinence and prolapse

Consensus-based recommendation E7-20
Expert consensus	Level of consensus +++
Women must be informed about the risk of postoperative stress urinary incontinence following prolapse surgery (strong recommendation).

Consensus-based recommendation E7-21
Expert consensus	Level of consensus +++
Female patients must be informed that the benefit of an incontinence operation may involve the disadvantage of increased complications (strong recommendation).

Consensus-based recommendation E7-22
Expert consensus	Level of consensus +++
Surgical rectification of stress urinary incontinence should be carried out after the patient no longer wishes to have further children as subsequent pregnancy and childbirth factors may negatively affect the positive continence outcome of surgery (recommendation).

Consensus-based recommendation E7-23
Expert consensus	Level of consensus +++
The decision that surgical treatment is indicated and the choice of surgical procedure for women with stress urinary incontinence who still wish to have children should be made in a center by a surgeon with the appropriate expertise (recommendation).

[Fig. 1] shows the algorithm used for the diagnostic workup and for the conservative and surgical treatment of different forms of urinary incontinence.

Fig. 1 Flowchart for the diagnosis and therapy of female urinary incontinence. [rerif]

3  Iatrogenic urogenital fistula

3.1  Introduction

Most non-childbirth-related urogenital fistulas are of iatrogenic origin; causes include pelvic surgery, especially following hysterectomy, pessary therapy, and radiotherapy. The risk from a pelvic operation increases in proportion to the complexity of the procedure, the extent of the primary disease, and whether the patient has previously undergone radiotherapy. The majority of all urinary/urogenital fistulas reported in German-speaking areas are of iatrogenic origin. In contrast to emerging countries, childbirth-related fistulas or malignant urinary fistulas have become very rare in German-speaking countries.

3.2  Diagnostic workup

The cardinal symptom of urogenital fistula is uncontrollable loss of urine. Depending on the size or location of the fistula, urine loss may either be continuous or take the form of a sudden gush of urine which depends on the patientʼs position, and it typically manifests equally strongly by day and by night. This is what differentiates extra-urethral incontinence pathognomonically from stress urinary incontinence, which is usually more pronounced during the day compared to at night, and from incontinence after urinary diversion (e.g., ileal neobladder), which is more noticeable at night for reasons related to the parasympathetic nervous system.

The diagnostic examination for vesicovaginal fistula (VVF) includes: patientʼs prior medical history, speculum examination, endoscopic examinations (urethrocystoscopy, ureteroscopy), retrograde bladder filling, and adding dye to the solution if necessary (indigo carmine excretion test). Placement of a tampon in the vagina to identify staining may make it easier to obtain a diagnosis.

CT and MRI may offer additional information in complex cases (e.g., malignancy-related fistulas).

3.3  Management of vesicovaginal fistula

Conservative management

Smaller fistulas may heal spontaneously if conservative management is started early and includes adequate emptying of the bladder using a bladder catheter or ureteral stent. But conservative management should no longer be attempted if the fistula has already persisted for more than three months as the likelihood of spontaneous healing is minimal after three months because epithelialization of the fistula canal will have already set in.

Surgical management

Timing of surgery

Results from non-controlled case series indicate that there are no differences in the success rates following early or delayed closure of a VVF, although it should be noted that the definition of immediate and delayed closure was inconsistent across studies. The expert consensus is, however, that it is useful to avoid any time pressure to close the fistula and it is better to delay closure until the local inflammatory response has subsided. This is expected to take 8 – 12 weeks.

Consensus-based statement S8-01
Expert consensus	Level of consensus +++
The primary approach depends on the location of the fistula, the patientʼs habits, and the surgeonʼs preference/expertise.

Consensus-based recommendation E8-01
Expert consensus	Level of consensus +++
Conservative management of a vesicovaginal fistula detected early postoperatively (within the first 6 weeks) with continuous urinary diversion (for up to 12 weeks) may result in spontaneous healing (open recommendation).

Consensus-based recommendation E8-02
Expert consensus	Level of consensus +++
Conservative and surgical management of fistulas should be reserved for experienced surgeons/interdisciplinary centers which offer a wide range of therapies, allowing the appropriate treatment to be selected according to the individual needs of the patient (recommendation).

Consensus-based recommendation E8-03
Expert consensus	Level of consensus +++
The timing of surgical fistula closure must depend on the individual circumstances, i.e., when the wound edema, inflammation, tissue necrosis or infection has subsided (strong recommendation).

Consensus-based recommendation E8-04
Expert consensus	Level of consensus +++
Primary care for a fistula must include separation of the organs connected by the fistula, excision of the fistula canal/refreshing of the wound edges, and tension-free suturing, possibly with interposition of tissue, irrespective of the chosen approach. Tissue interposition must be done when closing a radiogenic fistula (strong recommendation).

3.4  Surgical fistula closure

Vaginal techniques

When using a vaginal approach, the classic technique of de-epithelialization/partial colpocleisis, e.g., the Latzko procedure or the more commonly used technique of dissection with closure of the fistula in layers, can be used to close vesicovaginal fistulas. There are currently no data comparing the outcomes of both techniques.

Abdominal procedure

An abdominal approach is indicated when fistulas are located high up in tissue and cannot be accessed via the vagina. A transvesical approach has the advantage that it is entirely extraperitoneal. A simple transperitoneal approach is used less often, although it is preferred by surgeons who use a laparoscopic approach. Many urologists prefer using a combined transperitoneal and transvesical approach.

Tisse interposition

Tissue flaps are often interposed to serve as an additional layer during VVF surgery. Although the evidence for this is limited, the expert consensus is that interposing tissue in certain situations (e.g., recurrence, irradiation, large fistulas, lack of perfusion) may improve the outcome.

3.5  Management of post-radiogenic fistula

The results of surgical fistula closure are worse for post-radiogenic fistulas compared to iatrogenic fistulas. Because of the radiation-related changes to tissue, temporary or even permanent urinary diversion and/or placement of an enterostomy may be unavoidable.

3.6  Management of ureteral fistula

Basic principles

Female patients with a high risk of ureteral injury should be operated on by experienced surgeons who are able to expose the ureter and recognize injuries. But many ureteral injuries are only detected postoperatively (e.g., thermal lesions), meaning that an appropriate diagnostic workup should be initiated if the clinical symptoms appear to point to ureteral injury.

Ureterovaginal fistula

The respective choice of ureteral reconstruction depends on the location and extent of the ureteral lesion and the chosen approach must depend on the individual circumstances.

3.7  Management of urethrovaginal fistula

Etiology

Although urethrovaginal fistulas are rare, most urethrovaginal fistulas in adults have an iatrogenic etiology. Causes of iatrogenic urethrovaginal fistula are surgical treatment of stress urinary incontinence using bulking agents or synthetic slings, the excision of urethral diverticula, and genital reconstruction. Radiotherapy and even conservative prolapse treatment using pessaries may lead to the formation of fistulas.

Diagnosis

A clinical vaginal examination which includes a standard three-swab test is often sufficient t diagnose the presence of a urethral fistula. Urethroscopy and cystoscopy may be carried out to evaluate the extent and location of the fistula. Micturating cystourethrogram (MCUG) or ultrasound may be useful if the diagnosis is more difficult. CT and MRI are not part of the standard diagnostic workup.

Surgical therapy

The choice of surgery depends on the size, location, and etiology of the fistula as well as the amount of tissue loss. Reconstruction must include identification of the fistula, creation of a layer between the vaginal wall and the ureteral wall, watertight closure of the ureteral wall, interposition of tissue where possible, and closure of the vaginal wall.

Vaginal approach

Consensus-based recommendation E8-05
Expert consensus	Level of consensus +++
Treatment of a urethrovaginal fistula must be carried out primarily using a vaginal approach (strong recommendation).

Flaps and neourethra

A vaginal Martius flap or pedicled labial skin flap may be used to cover the urethral suture and for tissue interposition. Labial skin may be used to cover a urethral defect or to form a neourethra.

Consensus-based recommendation E8-06
Expert consensus	Level of consensus +++
After closure of a vesicovaginal and a urethrovaginal fistula, continuous urinary diversion must be ensured for at least 7 days (strong recommendation).

Consensus-based recommendation E8-07
Expert consensus	Level of consensus +++
Ureteral fistula must be suspected if female patients exhibit fluid leakage or urinary stasis in the postoperative period following a pelvic procedure or if there are high creatinine levels in the drainage fluid/free fluid in the abdominal cavity (strong recommendation).

Consensus-based recommendation E8-08
Expert consensus	Level of consensus +++
Fistulas in the upper urinary tract should be primarily treated conservatively or with endoluminal techniques (recommendation).

Consensus-based recommendation E8-09
Expert consensus	Level of consensus +++
Female patients treated for ureteral injuries must be followed up very closely after removal of the ureteral stent to exclude ureteral stricture which could limit renal function (strong recommendation).

Consensus-based recommendation E8-10
Expert consensus	Level of consensus ++
Depending on the location and extent of the lesion, surgical therapy of the ureter must be done on an individualized basis if conservative treatment of ureteral leakage fails (strong recommendation).

The references are listed in the long version of the guideline (https://register.awmf.org/de/leitlinien/detail/015-091).

Conflict of Interest

The conflicts of interest of the authors are listed in the long version of the guideline (https://register.awmf.org/de/leitlinien/detail/015-091)./
Die Interessenkonflikte der Autoren sind in der Langfassung der Leitlinie (https://register.awmf.org/de/leitlinien/detail/015-091) aufgelistet.

Publication History

Received: 19 October 2022

Accepted after revision: 23 October 2022

Article published online:
20 January 2023