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Surgical Treatment of Female Stress Urinary Incontinence (SUI): AUA/SUFU Guideline
Using AUA Guidelines
This AUA guideline is provided free of use to the general public for academic and research purposes. However, any person or company accessing AUA guidelines for promotional or commercial use must obtain a licensed copy. To obtain the licensable copy of this guideline, please contact Keith Price at kprice@auanet.org.
(Published 2017; Amended 2023)
To cite this guideline:
Kobashi KC, Vasavada S, Bloschichak A, et al. Updates to surgical treatment of female stress urinary incontinence (SUI): AUA/SUFU guideline (2023). J Urol. 2023;209(6):1091-1098.
SUI Unabridged [pdf]
Algorithm associated with this Guideline [pdf]
SUI Amendment Summary [pdf]
Citation: Kobashi KC, Albo ME, Dmochowski RR et al: Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline. J Urol 2017; 198: 875.
Panel Members
Kathleen C. Kobashi, MD; Michael E. Albo, MD; Roger R. Dmochowski, MD; David A. Ginsberg, MD; Howard B. Goldman, MD; Alexander Gomelsky, MD; Stephen R. Kraus, MD, Jaspreet S. Sandhu, MD; Tracy Shepler; Jonathan R. Treadwell, PhD; Sandip Vasavada, MD; Gary E. Lemack, MD
Amendment
Kathleen C. Kobashi, MD; Sandip Vasavada, MD; Aaron Bloschichak, MPH; Linnea Hermanson, MA; Janice Kaczmarek, MS; Rena Malik, MD
SUMMARY
Purpose
Stress urinary incontinence (SUI) is a common problem experienced by many women. SUI can have a significant negative impact on the quality of life (QOL) of not only those who suffer from the condition, but also potentially on those friends and family members whose lives and activities may also be limited.
Methodology
A comprehensive search of the literature was performed by ECRI Institute. This search included articles published between January 1, 2005 and December 31, 2015. In 2023, the SUI guideline was updated through the American Urological Association (AUA) amendment process in which newly published literature is reviewed and integrated into previously published guidelines in an effort to maintain currency. The amendment allowed for the incorporation of additional literature released since the initial publication of this guideline in 2017. For this update, the methodology team searched for studies published between January 1, 2016, and February 28, 2022.
GUIDELINE STATEMENTS
Patient Evaluation
- In the initial evaluation of patients with SUI desiring to undergo surgical intervention, clinicians should include the following components: (Clinical Principle)
- History, including assessment of bother
- Physical examination, including a pelvic examination
- Objective demonstration of SUI with a comfortably full bladder (any method)
- Assessment of post-void residual urine (any method)
- Urinalysis
- Clinicians should perform additional evaluations in patients being considered for surgical intervention who have the following conditions: (Expert Opinion)
- Inability to make definitive diagnosis based on symptoms and initial evaluation
- Inability to demonstrate SUI
- Known or suspected neurogenic lower urinary tract dysfunction
- Abnormal urinalysis, such as unexplained hematuria or pyuria
- Urgency-predominant mixed urinary incontinence (MUI)
- Elevated post-void residual per clinician judgment
- High grade pelvic organ prolapse (POP-Q stage 3 or higher) if SUI is not demonstrated with pelvic organ prolapse reduction
- Evidence of significant voiding dysfunction
- Clinicians may perform additional evaluations in patients with the following conditions: (Expert Opinion)
- Concomitant overactive bladder symptoms
- Failure of prior anti-incontinence surgery
- Prior pelvic prolapse surgery
Cystoscopy and Urodynamics Testing
- Clinicians should not perform cystoscopy in index patients for the evaluation of SUI unless there is a concern for urinary tract abnormalities. (Clinical Principle)
- Clinicians may omit urodynamic testing for the index patient desiring treatment when SUI is clearly demonstrated. (Conditional Recommendation; Evidence Level: Grade B)
- Clinicians may perform urodynamic testing in non-index patients. (Expert Opinion)
Patient Counseling
- In patients wishing to undergo treatment for SUI, the degree of bother that their symptoms are causing them should be considered in their decision for therapy. (Expert Opinion)
- In patients with SUI or stress-predominant MUI who wish to undergo treatment, clinicians should counsel regarding the availability of the following treatment options: (Clinical Principle)
- Observation
- Pelvic floor muscle training (± biofeedback)
- Other non-surgical options (e.g., continence pessary)
- Surgical intervention
- Clinicians should counsel patients on potential complications specific to the treatment options. (Clinical Principle)
- Prior to selecting midurethral synthetic sling procedures for the surgical treatment of SUI in women, clinicians must discuss the specific risks and benefits of mesh as well as the alternatives to a mesh sling. (Clinical Principle)
Treatment
- In patients with SUI or stress-predominant MUI, clinicians may offer the following non-surgical treatment options: (Expert Opinion)
- Continence pessary
- Vaginal inserts
- Pelvic floor muscle exercises (PFME) ± biofeedback
- Clinicians should counsel index patients considering surgery for SUI regarding the efficacy and safety of each of their options, which may include the following: (Strong Recommendation; Evidence Level: Grade A)
- Midurethral sling (retropubic, transobturator, or single-incision sling)
- Autologous fascia pubovaginal sling
- Burch colposuspension
- Bulking agents
- In index patients who select midurethral sling surgery, clinicians may offer a retropubic, transobturator, or single-incision sling. (Conditional Recommendation; Evidence Level: Grade A [retropubic/transobturator midurethral sling]/Grade B [single-incision sling])
- Clinicians should not place a mesh sling if the urethra is inadvertently injured at the time of planned midurethral sling procedure. (Clinical Principle)
- Clinicians should not offer stem cell therapy (SCT) for stress incontinent patients outside of investigative protocols. (Expert Opinion)
Special Cases
- In patients with SUI and a fixed, immobile urethra who wish to undergo treatment, clinicians may offer pubovaginal slings, retropubic midurethral slings, urethral bulking agents, or adjustable retropubic midurethral slings. (Expert Opinion)
- Clinicians should not utilize a synthetic midurethral sling in patients undergoing concomitant urethral diverticulectomy, repair of urethrovaginal fistula, or urethral mesh excision and stress incontinence surgery. (Clinical Principle)
- Clinicians should strongly consider avoiding the use of mesh in patients undergoing stress incontinence surgery who are at risk for poor wound healing (e.g., following radiation therapy, presence of significant scarring, poor tissue quality). (Expert Opinion)
- In patients undergoing concomitant surgery for pelvic prolapse repair and SUI, clinicians may perform any of the incontinence procedures (e.g., midurethral sling, pubovaginal sling, Burch colposuspension). (Conditional Recommendation; Evidence Level: Grade C)
- Clinicians may offer patients with SUI and concomitant neurologic disease affecting lower urinary tract function (neurogenic bladder) surgical treatment of SUI after appropriate evaluation and counseling have been performed. (Expert Opinion)
- Clinicians may offer synthetic midurethral slings, in addition to other sling types, to the following patient populations after appropriate evaluation and counseling have been performed: (Expert Opinion)
- Patients planning to bear children
- Diabetes
- Obesity
- Geriatric
Outcomes Assessment
- In women with severe outlet dysfunction or recurrent or persistent SUI after surgical intervention (e.g., surgical failure), clinicians may offer placement of an obstructing pubovaginal sling (PVS) or bladder neck closure with urinary drainage after counseling regarding the risks, benefits, and alternatives. (Expert Opinion)
- Clinicians or their designees should communicate with patients within the early postoperative period to assess if patients are having any significant voiding problems, pain, or other unanticipated events. If patients are experiencing any of these outcomes, they should be seen and examined. (Expert Opinion)
- Patients should be seen and examined by their clinicians or designees within six months post-operatively. Patients with unfavorable outcomes may require additional follow-up. (Expert Opinion)
- The subjective outcome of surgery as perceived by the patient should be assessed and documented.
- Patients should be asked about residual incontinence, ease of voiding/force of stream, recent urinary tract infection (UTI), pain, sexual function and new onset or worsened overactive bladder symptoms.
- A physical exam, including an examination of all surgical incision sites, should be performed to evaluate healing, tenderness, mesh extrusion (in the case of synthetic slings), and any other potential abnormalities.
- A post-void residual should be obtained.
INTRODUCTION
Purpose
As stated before, SUI is a common problem experienced by many women. The surgical options for the treatment of SUI continue to evolve; as such, this guideline and the associated algorithm aims to outline the currently available treatment techniques as well as the data associated with each treatment. It should be noted that some of the data included in the analysis involved techniques that are no longer commercially available for reasons not necessarily related to outcomes. Indeed, the Panel recognizes that this guideline will require continued literature review and updating as further knowledge regarding current and future options continues to develop.
Terminology and Definitions
The prevalence of SUI has been reported to be as high as 49%, depending on population and definition, and it can have a significant negative impact on an individual's QOL and on that of her family and friends.1-3 While many women choose surgical management for their SUI, the specific options for surgical treatment have evolved over time.4 The first AUA Female SUI Guideline Panel reviewed available literature up to 1994 while the literature search for the SUI Guideline Panel that directly preceded the present iteration concluded in June 2005.5 Indeed, the Panel recognized that given the rapidly changing landscape, this guideline would require ongoing literature review and continual updates to keep up with further developments in the management of SUI.
Index Patient
The index patient for this guideline, as in the previous SUI guideline iterations, is an otherwise healthy female who is considering surgical therapy for the correction of pure stress and/or stress-predominant MUI who has not undergone previous SUI surgery. Patients with low-grade pelvic organ prolapse were also considered to be index patients. However, while the stage of prolapse was often specified in more recent trials, it was not indicated in many of the earlier studies. Where evidence was available, the data is presented separately for index patients and non-index patients. The Panel recognizes that many women who seek surgical correction for SUI do not meet this definition of an index patient. In fact, most of the studies in the literature do not enroll patients based on this definition of an index patient. Therefore, the Panel felt it was also important to review the literature regarding patients undergoing surgery for SUI that did not meet this definition of an index patient.
Non-Index Patient
Non-index patients reviewed in this analysis include women with SUI and pelvic prolapse (stage 3 or 4), MUI (non-stress-predominant), incomplete emptying/elevated post-void residual (PVR) and/or other voiding dysfunction, prior surgical interventions for SUI, recurrent or persistent SUI, mesh complications, high body mass index (BMI), neurogenic lower urinary tract dysfunction and advanced age (geriatric). Finally, the Panel felt it was important to more fully understand the literature regarding the safety of mesh products used in the surgical treatment of SUI and, therefore, included studies of women who had undergone mesh procedures regardless of whether they were index or non-index patients. The Panel also acknowledges that persistent or recurrent SUI following any SUI treatment is not uncommon; however, there is a lack of robust data to substantiate any recommendation from the Panel regarding the management of these patients.
Definitions
SUI is the symptom of urinary leakage due to increased abdominal pressure, which can be caused by activities such as sneezing, coughing, exercise, lifting, and position change. Though the utility of urethral function assessment remains controversial, some clinicians utilize leak point pressure and others utilize urethral closure pressure. Intrinsic sphincter deficiency (ISD) is often defined as a leak point pressure of less than 60 cm H20 or a maximal urethral closure pressure of less than 20 cm H20, often in the face of minimal urethral mobility. Urgency urinary incontinence (UUI) is the symptom of urinary leakage that occurs in conjunction with the feeling of urgency and a sudden desire to urinate that cannot be deferred. Mixed incontinence refers to a combination of SUI and UUI.
METHODOLOGY
The systematic review utilized to inform this guideline was conducted by a methodology team at ECRI Institute. Determination of the guideline scope and review of the final systematic review to inform guideline statements was conducted in conjunction with the SUI Panel.
Panel Formation
The Surgical Treatment of Female Stress Urinary Incontinence Panel was created in 2014 by the American Urological Association Education and Research, Inc. (AUAER). The Practice Guidelines Committee (PGC) of the AUA selected the Panel Chair who in turn appointed the Vice Chair. In a collaborative process, additional panel members, including additional members of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) with specific expertise in this area, were then nominated and approved by the PGC. Panel members received no remuneration for their work.
The Surgical Treatment of Female Stress Urinary Incontinence Amendment Panel was created in 2022, by the AUA, to review new literature and update this guideline with up-to-date information. Panel members received no renumeration for their work.
Searches and Article Selection
A comprehensive search of the literature was performed by the ECRI Institute which included articles published between January 1, 2005 and December 31, 2015. Study designs included systematic reviews, randomized controlled trials (RCTs), controlled clinical trials (CCTs), and observational studies (diagnostic accuracy studies, cohort with and without comparison group, case-control, case series). Three methodologic research analysts reviewed the abstracts identified in the literature search; each article was screened by at least two of the three analysts. Articles that potentially fulfilled the outlined inclusion criteria and potentially answered one or more of the Key Questions specified by the Panel were retrieved in full text for review by the team. For all excluded studies, analysts recorded the reason for exclusion as well as whether the exclusion was based on abstract review or full-text review. To focus the analysis on the most relevant evidence, analysts only considered articles published in full after January 1, 2005 in the English language and reported SUI data for one or more of the Key Questions. An update abstract search was conducted through September 2016, which pulled in an additional 66 abstracts related to the Key Questions of interest.
Included interventions: Included interventions were limited to those that were FDA-approved with adequate robust data. Injectable bulking agents (Macroplastique, Coaptite, Contigen [collagen], silicone, Durasphere [carbon coated zirconium beads]); retropubic bladder neck suspensions (Burch colposuspension); midurethral slings(MUS) (retropubic [SPARC, tension-free vaginal tape (TVT), ALIGN, Supris, Advantage, Lynx, Desara, I-STOP, TFS], transobturator [tension-free vaginal tape-obturator (TVT-O), Monarc, ALIGN TO, Obtryx, Aris], Prepubic, Adjustable [Remeex]); pubovaginal slings (PVS) (autologous, allograft, xenograft); artificial urinary sphincter (AUS); single incision (Altis, MiniArc, Ajust, Solyx, SIMS, TVT-Secure)
Excluded interventions: Laparoscopic colposuspension*, Obtape, ProteGen, Gore-Tex, bone-anchor, multifilament, In-Fast, anterior vaginal wall sling, Renessa, stem cell/tissue engineering, adjustable continence therapy, Bulkamid, MMK (Marshall-Marchetti-Krantz), needle suspensions (Stamey, Pereyra, Raz, Gittes), anterior colporrhaphy, Kelly plication.
*While the Panel acknowledges that a minimally invasive Burch colposuspension may be utilized by some individuals, neither laparoscopic nor robotic Burch colposuspension, specifically, were included due to the lack of sufficient data regarding these approaches in the literature.
Included comparisons: Any comparisons of two or more of the included interventions was incorporated, though not all comparisons within a given category (e.g., comparisons of two bulking agents, or comparisons of two retropubic midurethral slings [RMUS]) were included. Additionally, analysts compared bottom-up versus top-down RMUS, as well as outside-in versus inside-out transobturator midurethral slings (TMUS).
The following outcomes are included in this review: QOL questionnaires (symptom, QOL, sexual function, satisfaction, expectation, bother), voiding diaries, stress test, pad test, urodynamics, surgical complications/adverse events, need for retreatment, UITN-based criteria, and complications (e.g., erosion, extrusion, retention, voiding dysfunction, perforation, dyspareunia, obstruction, exposure, de novo urgency, recurrent urinary tract infection [UTI], bleeding, pain, neuropathy, neurovascular or visceral injury, hematoma, infection, hernia, seroma, slow stream). Many studies reported rates of “success” or “failure,” which was defined differently by different studies. Generally, outcomes were based on a set of variables such as stress tests, patient reports, and the need for retreatment.
Of the 450 publications retrieved for full review, 256 were excluded. The most common reasons for exclusion were RCTs that were a part of already included systematic reviews to avoid duplication.
Data Abstraction
Information from each included article was extracted by one of three analysts using standard extraction forms. The team lead developed the forms and trained the extractors. The lead reviewed the work of the other extractors and searched for inconsistencies and missing information in the extracted data.
Risk of Bias Assessment
Because different Key Questions involved different types of evidence, analysts tailored the quality assessments as follows:
- For systematic reviews, analysts rated the quality based on the review authors’ ratings of the quality of their included studies (if review authors did not rate the quality, analysts extrapolated a rating based on their description of study limitations). For diagnostic cohort studies, analysts used the QUADAS-2 instrument.6
- In reviewing effectiveness, analysts judged the quality of systematic reviews and RCTs using the same processes as previously discussed.
- For complications, analysts divided the evidence into comparative data (comprising of systematic reviews and RCTs) and non-comparative data (comprising individual groups from RCTs and non-randomized studies).
- For comparative data, analysts used the same processes as previously discussed. For non-comparative data, analysts considered three items: prospective design, consecutive enrollment, and objective measurement of outcome. If all three were clearly true, the study was high quality; if just one was false or unclear, the study was moderate quality. If two or three were false or unclear, the study was low quality.
- In reviewing contraindications for MUS and indications for injectables, analysts did not assess quality because those questions involve patient enrollment criteria.
- In reviewing preoperative cystoscopy, analysts identified no studies on the effect of preoperative cystoscopy, so no quality assessment was necessary.
- For urodynamics, analysts judged the quality of randomized trials using the Cochrane risk-of-bias instrument.7
- For patient factors predicting outcomes, analysts used the Quality in Prognostic Studies (QUIPS) tool.8
- In reviewing outcomes instruments, analysts did not assess quality since it is not clear what would constitute a high quality study of instruments utilized to assess such outcomes.
- In reviewing length of follow-up, analysts judged quality solely on the basis of the percentage of enrolled patients who provided data during follow-up. Studies for which all follow up time points had 85%+ completion were deemed high quality; studies for which any follow up time point had 60% or less completion were deemed low quality; all others were deemed moderate quality.
Determination of Evidence Strength
The categorization of evidence strength is conceptually distinct from the quality of individual studies. Evidence strength refers to the body of evidence available for a particular question and includes not only individual study quality but consideration of study design, consistency of findings across studies, adequacy of sample sizes, and generalizability of samples, settings, and treatments for the purposes of the guideline. The AUA categorizes body of evidence strength as Grade A (well-conducted and highly-generalizable RCTs or exceptionally strong observational studies with consistent findings), Grade B (RCTs with some weaknesses of procedure or generalizability or moderately strong observational studies with consistent findings), or Grade C (RCTs with serious deficiencies of procedure or generalizability or extremely small sample sizes or observational studies that are inconsistent, have small sample sizes, or have other problems that potentially confound interpretation of data). By definition, Grade A evidence is evidence about which the Panel has a high level of certainty, Grade B evidence is evidence about which the Panel has a moderate level of certainty, and Grade C evidence is evidence about which the Panel has a low level of certainty.9
AUA Nomenclature: Linking Statement Type to Evidence Strength
The AUA nomenclature system explicitly links statement type to body of evidence strength, level of certainty, magnitude of benefit or risk/burdens, and the Panel’s judgment regarding the balance between benefits and risks/burdens (Table 1). Strong Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is substantial. Moderate Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is moderate. Conditional Recommendations are non-directive statements used when the evidence indicates that there is no apparent net benefit or harm or when the balance between benefits and risks/burden is unclear. All three statement types may be supported by any body of evidence strength grade. Body of evidence strength Grade A in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances and that future research is unlikely to change confidence. Body of evidence strength Grade B in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances but that better evidence could change confidence. Body of evidence strength Grade C in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances but that better evidence is likely to change confidence. Body of evidence strength Grade C is only rarely used in support of a Strong Recommendation. Conditional Recommendations also can be supported by any evidence strength. When body of evidence strength is Grade A, the statement indicates that benefits and risks/burdens appear balanced, the best action depends on patient circumstances, and future research is unlikely to change confidence. When body of evidence strength Grade B is used, benefits and risks/burdens appear balanced, the best action also depends on individual patient circumstances and better evidence could change confidence. When body of evidence strength Grade C is used, there is uncertainty regarding the balance between benefits and risks/burdens, alternative strategies may be equally reasonable, and better evidence is likely to change confidence.
Where gaps in the evidence existed, the Panel provides guidance in the form of Clinical Principles or Expert Opinion with consensus achieved using a modified Delphi technique if differences of opinion emerged.10 A Clinical Principle is a statement for which there may or may not be evidence in the medical literature and that is widely agreed upon by urologists or other clinicians. Expert Opinion refers to a statement for which there is no evidence and that is achieved by consensus of the Panel.
Table 1: AUA Nomenclature Linking Statement Type to Level of Certainty, Magnitude of Benefit or Risk/Burden, and Body of Evidence Strength
Peer Review and Document Approval
The AUA conducted a thorough peer review process in October of 2016. The draft guidelines document was distributed to 93 peer reviewers, 41 of which submitted comments. The Panel reviewed and discussed all submitted comments and revised the draft as needed. Once finalized, the guideline was submitted for approval to the PGC and Science and Quality Council (SQC). It was then submitted to the AUA and SUFU Boards of Directors (BODs) for final approval.
In 2023, as a part of the amendment process, the AUA conducted a thorough peer review process. A call for peer reviewers was posted on November 2022 and the draft guideline document was distributed to 70 peer reviewers, 21 of which submitted comments. The Amendment Panel reviewed and discussed all submitted comments and revised the draft as needed. Once finalized, the guideline was submitted for approval to the PGC and SQC. It was then submitted to AUA BODs for final approval. Panel members received no renumeration for their work.
GUIDELINE STATEMENTS
Patient Evaluation
Guideline Statement 1
In the initial evaluation of patients with SUI desiring to undergo surgical intervention, clinicians should include the following components: (Clinical Principle)
- Focused history, including assessment of bother
- Focused physical examination, including a pelvic examination
- Objective demonstration of SUI with a comfortably full bladder (any method)
- Assessment of post-void residual urine (any method)
- Urinalysis
Guideline Statement 2
Clinicians should perform additional evaluations in patients being considered for surgical intervention who have the following conditions: (Expert Opinion)
- Inability to make definitive diagnosis based on symptoms and initial evaluation
- Inability to demonstrate SUI
- Known or suspected neurogenic lower urinary tract dysfunction
- Abnormal urinalysis, such as unexplained hematuria or pyuria
- Urgency-predominant MUI
- Elevated post-void residual per clinician judgment
- High grade pelvic organ prolapse (POP-Q stage 3 or higher) if SUI is not demonstrated by pelvic organ prolapse reduction
- Evidence of significant voiding dysfunction
Guideline Statement 3
Clinicians may perform additional evaluations in patients with the following conditions: (Expert Opinion)
- Concomitant overactive bladder symptoms
- Failure of prior anti-incontinence surgery
- Prior pelvic prolapse surgery
Cystoscopy & Urodynamics Testing
Guideline Statement 4
Clinicians should not perform cystoscopy in index patients for the evaluation of SUI unless there is a concern for urinary tract abnormalities. (Clinical Principle)
Guideline Statement 5
Clinicians may omit urodynamic testing for the index patient desiring treatment when SUI is clearly demonstrated. (Conditional Recommendation; Evidence Level: Grade B)
Guideline Statement 6
Clinicians may perform urodynamic testing in non-index patients. (Expert Opinion)
Patient Counseling
Guideline Statement 7
In patients wishing to undergo treatment for SUI, the degree of bother that their symptoms are causing them should be considered in their decision for therapy. (Expert Opinion)
Guideline Statement 8
In patients with SUI or stress-predominant MUI who wish to undergo treatment, clinicians should counsel regarding the availability of the following treatment options: (Clinical Principle)
- Observation
- Pelvic floor muscle training (± biofeedback)
- Other non-surgical options (e.g., continence pessary)
- Surgical intervention
Guideline Statement 9
Clinicians should counsel patients on potential complications specific to the treatment options. (Clinical Principle)
Guideline Statement 10
Prior to selecting midurethral synthetic sling procedures for the surgical treatment of SUI in women, clinicians must discuss the specific risks and benefits of mesh as well as the alternatives to a mesh sling. (Clinical Principle)
Treatment
Guideline Statement 11
In patients with SUI or stress-predominant MUI, clinicians may offer the following non-surgical treatment options: (Expert Opinion)
- Continence pessary
- Vaginal inserts
- Pelvic floor muscle exercises (PFME) ± biofeedback
Guideline Statement 12
Clinicians should counsel index patients considering surgery for SUI regarding the efficacy and safety of each of their options, which may include the following: (Strong Recommendation; Evidence Level: Grade A)
- Midurethral sling (retropubic, transobturator, or single-incision sling)
- Autologous fascia pubovaginal sling
- Burch colposuspension
- Bulking agents
Guideline Statement 13
In index patients who select midurethral sling surgery, clinicians may offer a retropubic, transobturator, or single-incision sling. (Conditional Recommendation; Evidence Level: Grade A [retropubic/transobturator midurethral sling]/Grade B [single-incision sling])
Discussion for Statements 12 & 13
Guideline Statement 14
Clinicians should not place a mesh sling if the urethra is inadvertently injured at the time of planned midurethral sling procedure. (Clinical Principle)
Guideline Statement 15
Clinicians should not offer SCT for stress incontinent patients outside of investigative protocols. (Expert Opinion)
Special Cases
Guideline Statement 16
In patients with SUI and a fixed, immobile urethra who wish to undergo treatment, clinicians may offer pubovaginal slings, retropubic midurethral slings, urethral bulking agents, or adjustable retropubic midurethral slings. (Expert Opinion)
Guideline Statement 17
Clinicians should not utilize a synthetic midurethral sling in patients undergoing concomitant urethral diverticulectomy, repair of urethrovaginal fistula, or urethral mesh excision and stress incontinence surgery. (Clinical Principle)
Guideline Statement 18
Clinicians should strongly consider avoiding the use of mesh in patients undergoing stress incontinence surgery who are at risk for poor wound healing (e.g., following radiation therapy, presence of significant scarring, poor tissue quality). (Expert Opinion)
Guideline Statement 19
In patients undergoing concomitant surgery for pelvic prolapse repair and SUI, clinicians may perform any of the incontinence procedures (e.g., midurethral sling, pubovaginal sling, or Burch colposuspension). (Conditional Recommendation; Evidence Level: Grade C)
Guideline Statement 20
Clinicians may offer patients with SUI and concomitant neurologic disease affecting lower urinary tract function (neurogenic bladder) surgical treatment of SUI after appropriate evaluation and counseling have been performed. (Expert Opinion)
Guideline Statement 21
Clinicians may offer synthetic midurethral slings, in addition to other sling types, to the following patient populations after appropriate evaluation and counseling have been performed: (Expert Opinion)
- Patients planning to bear children
- Diabetes
- Obesity
- Geriatric
Outcomes Assessment
Guideline Statement 22
In women with severe outlet dysfunction or recurrent or persistent SUI after surgical intervention (e.g., surgical failure), clinicians may offer placement of an obstructing pubovaginal sling or bladder neck closure with urinary drainage after counseling regarding the risks, benefits, and alternatives. (Expert Opinion)
Guideline Statement 23
Clinicians or their designees should communicate with patients within the early postoperative period to assess if patients are having any significant voiding problems, pain, or other unanticipated events. If patients are experiencing any of these outcomes, they should be seen and examined. (Expert Opinion)
Guideline Statement 24
Patients should be seen and examined by their clinicians or designees within six months post-operatively. Patients with unfavorable outcomes may require additional follow-up. (Expert Opinion)
- The subjective outcome of surgery as perceived by the patient should be assessed and documented.
- Patients should be asked about residual incontinence, ease of voiding/force of stream, recent UTI, pain, sexual function and new onset or worsened overactive bladder symptoms.
- A physical exam, including an examination of all surgical incision sites, should be performed to evaluate healing, tenderness, mesh extrusion (in the case of synthetic slings), and any other potential abnormalities.
- A post-void residual should be obtained.
- A standardized questionnaire (e.g., PGI-I) may be considered.
FUTURE DIRECTIONS
Educational Opportunities
Continued emphasis on outcomes reporting has placed more focus on the importance of patient literacy in the informed consent process and the perioperative preparation schema. It is generally accepted that appropriate informed consent relies on adequate patient information and instruction. It is also clear that the complexity of functional urologic conditions such as female SUI provide unique and significant hurdles to patient understanding and appropriate determination of risk/benefit related to interventions for these conditions. Increased reliance on non-paper-based informational resources has evolved given the understanding that adult education requires repetitive delivery of information in discreet and discernable informatics groupings. Audiovisual content shows improvement in patient education, recall and informed consent that may be appropriate for women with SUI.127, 128 The use of validated questions such as “How confident are you filling out forms by yourself?”129 or expanded use of tests of functional health literacy in adults (TOFHLA) may expedite literacy assessments in unique individuals.
Improving and honing a clinician’s ability to provide valuable and comprehensible education for patients regarding their condition and therapeutic options are of clear importance in accomplishing successful treatment. Patients who understand their condition and the rationale behind their treatment are more satisfied with their outcomes.130 Accordingly, the development of ancillary tools that can supplement and move toward more effective and successful communication between patients and their surgeons would be of significant worth. Similarly, overcoming obstacles that result in disparities in healthcare, such as socioeconomic, language, and access barriers would provide great value to many.
Therapeutic Opportunities
In considering new treatments, stem cell injection for the indication of SUI represents possibly one of the most compelling emerging therapies. Stem cell use for the treatment of SUI has been proposed for more than ten years.130-134 Different stem cell populations have been evaluated for this indication. The six cell types include embryonic, muscle-derived (satellite cells), bone marrow-derived,135 mesenchymal, adipose, urinary, and human umbilical cord blood types. Human amniotic fluid stem cells (hAFSCs) have also been proposed.136, 137
Autologous muscle-derived cells (AMDSC) have been evaluated for intrasphincteric injection for SUI.138 The primary outcome was the incidence and severity of adverse events. Treatment related complications included minor events such as pain/bruising at the biopsy and injection sites. A higher percentage of patients receiving high doses (in terms of cell numbers) experienced a 50% or greater reduction in pad weight, had a 50% or greater reduction in diary-reported stress leaks and had zero to one leak during a 3-day period at final follow-up.
Stem cell use for the indication of SUI continues to evolve. Current evidence is limited by a lack of active comparator arms and outcomes limitations. Additionally, the optimal cell type, injection method, and final administration characteristics for cell transfer (inclusive of volume of viable cells) remain areas for improvement and study.
It is anticipated that as materials science advances, the use of nanoparticulate technology expands, and improved understanding of wound healing evolves, other therapies will arise for SUI. These therapies will need to be carefully vetted and assessed for safety and efficacy, and it is hoped that enhanced collaboration between regulatory, academic, and patient outcomes groups will provide continued improvement in interventions for SUI.
Laser and magnetic/electrical stimulation therapy are emerging therapies for the treatment of SUI. However, evidence to date is inconsistent and of poor quality. The Panel acknowledges that these therapies exist and may offer some benefit in index SUI patients seeking non-surgical treatment. However, given the limitations in rigorous evidence-based data supporting their use and FDA advisory warning against the use of energy-based devices for “vaginal rejuvenation”, patients should be extensively counseled on the immaturity of the data.
Two systematic reviews and one comparative study139-141 evaluated the safety and efficacy of Er:YAG and CO2 lasers on women with SUI. Studies included in the systematic reviews were limited by unclear or observational study design, lack of a control/comparator arms, short-term follow-up, poor methodological quality, and inconsistent results, thus limiting the applicability of the results.
Three meta-analyses comparing magnetic stimulation to sham or placebo142-144 were reviewed. The analysis of Hou et al.143 suffered from significant heterogeneity and serious risk of bias in many of the studies included. Sun et al142 found improvements in QOL and success rates; however, confidence intervals were wide and there was a lack of consistency in stimulation protocols. Despite these limitations, all meta-analyses concluded that magnetic stimulation appears to be safe and may be effective in reducing SUI.
A Cochrane review145 on electrical stimulation (ES) provided the most robust evidence on ES. This most recent review included 51 studies (n= 3781) that compared non-implanted ES to various other interventions (e.g., PFME, vaginal cones, sham) or no intervention. The current evidence base indicated that ES is probably more effective than no active or sham treatment, but it is not possible to say whether ES is similar to PFME or other active treatments in effectiveness or not. Overall, the quality of the evidence was too low to provide reliable results. A meta-analysis of 9 RCTs (n=982) comparing ES to sham ES or no intervention146 also identified improvements in QOL, possibly attributed to an additional favorable outcome with urinary frequency but only short-term (<3 month) improvement in urinary leakage.
The Panel concludes that while laser or magnetic/ES therapy may provide some benefit compared to placebo it remains vital to counsel patients on the immaturity of the data. It appears current data does not suggest superiority of these new emerging technologies in comparison to established non-invasive therapies such as PFME.
Standardization of Outcomes
While technology continues to evolve and new innovative techniques emerge, accurate assessment of outcomes following medical intervention is paramount to optimizing one’s ability to offer the best treatments for our patients. The lack of standardization around outcomes evaluation, assessment tools, and the very definition of success in pelvic floor medicine has been a long-standing barrier to advancement of the field. Treatment of SUI is no exception to this predicament, and the state of the current literature unequivocally illustrates that little has changed over the years. Many individuals have acknowledged this quandary over the past several decades147, 148, and just as many individuals have attempted to unite researchers in the field to establish minimum standards regarding the instruments utilized to measure the results of our interventions and to determine how a favorable outcome should be defined.149, 150 Only when this consensus is reached will it be possible to accomplish meaningful comparison of outcomes from one center to another, foster collaborative learning from one another, and truly advance the field.
Tools and Resources
ABBREVIATIONS
AMDSC | Autologous muscle-derived cells |
AUA | American Urological Association |
AUAER | American Urological Association Education and Research, Inc. |
AUGS | American Urogynecologic Society |
AUS | Artificial urinary sphincter |
BOD | Board of Directors |
BMI | Body mass index |
CCT | Controlled clinical trials |
CIC | Clean intermittent catheterization |
C-NDL | Contasure needleless |
DLS | Dynamic lumbopelvic stabilization |
ES | Electrical stimulation |
hAFSCs | Human amniotic fluid stem cells |
ICIQ-UI SF | Incontinence questionnaire-urinary incontinence short form |
ISD | Intrinsic urinary sphincter |
MUI | Mixed urinary incontinence |
MUS | Mid-urethral sling |
OAB | Overactive bladder |
PAHG | Polyacrylamide hydrogel |
PFME | Pelvic floor muscle exercises |
PGC | Practice Guidelines Committee |
PGI-I | Patient global impression of improvement |
POP | Pelvic organ prolapse |
PVR | Post-void residual |
PVS | Pubovaginal sling |
QOL | Quality of life |
RCT | Randomized controlled trial |
RMUS | Retropubic mid-urethral sling |
RR | Relative risk |
SQC | Science & Quality Council |
SIS | Single incision sling |
SMUS | Synthetic mid-urethral sling |
SUFU | Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction |
SUI | Stress urinary incontinence |
TMUS | Transobturator mid-urethral sling |
TOFHLA | Tests of functional health literacy in adults |
TOT | Transobturator tape |
TVT | Tension-free vaginal tape |
ULR | Update literature review |
UTI | Urinary tract infection |
UUI | Urgency urinary incontinence |
VLPP | Valsalva leak point pressure |
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