American Urological Association - Surgical Treatment of Female Stress Urinary Incontinence (SUI): AUA/SUFU Guideline

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Surgical Treatment of Female Stress Urinary Incontinence (SUI): AUA/SUFU Guideline

AUA/SUFU Guideline: Published 2017

Stress urinary incontinence (SUI) is a common problem in the field of Female Urology. This guideline evaluates both the index patient, defined as an otherwise healthy female considering surgical therapy for the correction of SUI, as well as the non-index patient, which includes those with high-grade prolapse as well as geriatric patients. Topics covered include evaluation and patient counseling, minimally invasive surgery procedures, outcomes assessment, and overall bladder health.

Unabridged version of this Guideline [pdf]
Algorithm associated with this Guideline [pdf]
Presentation from the 2017 Annual Meeting [pdf]

Panel Members

Kathleen C. Kobashi, MD, FACS, FPMRS; Michael E. Albo, MD; Roger R. Dmochowski, MD; David A. Ginsberg, MD; Howard B. Goldman, MD; Alexander Gomelsky, MD; Stephen R. Kraus, MD, FACS; Jaspreet S. Sandhu, MD; Tracy Shepler; Jonathan R. Treadwell, PhD; Sandip Vasavada, MD; Gary E. Lemack, MD

Executive 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. 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.

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. 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 that 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. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate) or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions.

Guideline Statements

Patient Evaluation

  1. In the initial evaluation of patients with stress urinary incontinence desiring to undergo surgical intervention, physicians should include the following components: (Clinical Principle)
    • History, including assessment of bother
    • Physical examination, including a pelvic examination
    • Objective demonstration of stress urinary incontinence with a comfortably full bladder (any method)
    • Assessment of post-void residual urine (any method)
    • Urinalysis
  1. Physicians 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 stress urinary incontinence
    • Known or suspected neurogenic lower urinary tract dysfunction
    • Abnormal urinalysis, such as unexplained hematuria or pyuria
    • Urgency-predominant mixed urinary incontinence
    • Elevated post-void residual per clinician judgment
    • High grade pelvic organ prolapse (POP-Q stage 3 or higher) if stress urinary incontinence not demonstrated with pelvic organ prolapse reduction
    • Evidence of significant voiding dysfunction
  1. Physicians 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

  1. Physicians should not perform cystoscopy in index patients for the evaluation of stress urinary incontinence unless there is a concern for urinary tract abnormalities. (Clinical Principle)
  2. Physicians may omit urodynamic testing for the index patient desiring treatment when stress urinary incontinence is clearly demonstrated. (Conditional Recommendation; Evidence Level: Grade B)
  3. Physicians may perform urodynamic testing in non-index patients. (Expert Opinion)

Patient Counseling

  1. In patients wishing to undergo treatment for stress urinary incontinence, the degree of bother that their symptoms are causing them should be considered in their decision for therapy. (Expert Opinion)
  2. In patients with stress urinary incontinence or stress-predominant mixed urinary incontinence who wish to undergo treatment, physicians 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
  1. Physicians should counsel patients on potential complications specific to the treatment options. (Clinical Principle)
  2. Prior to selecting midurethral synthetic sling procedures for the surgical treatment of stress urinary incontinence in women, physicians must discuss the specific risks and benefits of mesh as well as the alternatives to a mesh sling. (Clinical principle)

Treatment

  1. In patients with stress urinary incontinence or stress-predominant mixed urinary incontinence, physicians may offer the following non-surgical treatment options: (Expert Opinion)
    • Continence pessary
    • Vaginal inserts
    • Pelvic floor muscle exercises
  2. In index patients considering surgery for stress urinary incontinence, physicians may offer the following options: (Strong Recommendation; Evidence Level: Grade A)
    • Midurethral sling (synthetic)
    • Autologous fascia pubovaginal sling
    • Burch colposuspension
    • Bulking agents
  3. In index patients who select midurethral sling surgery, physicians may offer either the retropubic or transobturator midurethral sling. (Moderate Recommendation; Evidence Level: Grade A)
  4. Physicians may offer single-incision slings to index patients undergoing midurethral sling surgery with the patient informed as to the immaturity of evidence regarding their efficacy and safety. (Conditional Recommendation; Evidence Level: Grade B)
  5. Physicians should not place a mesh sling if the urethra is inadvertently injured at the time of planned midurethral sling procedure. (Clinical Principle)
  6. Physicians should not offer stem cell therapy for stress incontinent patients outside of investigative protocols. (Expert Opinion)

Special Cases

  1. In patients with stress urinary incontinence and a fixed, immobile urethra (often referred to as ‘intrinsic sphincter deficiency’) who wish to undergo treatment, physicians should offer pubovaginal slings, retropubic midurethral slings, or urethral bulking agents. (Expert Opinion)
  2. Physicians 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)
  3. Physicians 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)
  4. In patients undergoing concomitant surgery for pelvic prolapse repair and stress urinary incontinence, physicians may perform any of the incontinence procedures (e.g., midurethral sling, pubovaginal sling, Burch colposuspension). (Conditional Recommendation; Evidence Level: Grade C)
  5. Physicians may offer patients with stress urinary incontinence and concomitant neurologic disease affecting lower urinary tract function (neurogenic bladder) surgical treatment of stress urinary incontinence after appropriate evaluation and counseling have been performed. (Expert Opinion)
  6. Physicians 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

  1. Physicians 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)
  2. Patients should be seen and examined by their physicians 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, 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

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. 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.

Methodology

Systematic Review. A comprehensive search of the literature was performed by ECRI Institute. This search 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 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 that 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, TVT, ALIGN, Supris, Advantage, Lynx, Desara, I-STOP, TFS, transobturator TVT-O, Monarc, ALIGN TO, Obtryx, Aris, Prepubic, Adjustable Remeex); pubovaginal slings (PVS) (autologous, allograft, xenograft); artificial urinary sphincter; 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 Extraction and Data Management. 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.

Assessment of Quality. Because different Key Questions involved different types of evidence, analysts tailored the quality assessments as follows:

  • For systematic reviews, analysts rated quality based on the review authors’ ratings of the quality of their included studies (if review authors did not rate quality, analysts extrapolated a rating based on their description of study limitations). For diagnostic cohort studies, analysts used the QUADAS-2 instrument.1
  • 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 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.2
  • For patient factors predicting outcomes, analysts used the Quality in Prognostic Studies (QUIPS) tool.3
  • 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.4

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.5 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

 

Evidence Strength A

(High Certainty)

Evidence Strength B

(Moderate Certainty)

Evidence Strength C

(Low Certainty)

Strong Recommendation

 

(Net benefit or harm substantial)

Benefits > Risks/Burdens (or vice versa)

Net benefit (or net harm) is substantial

Applies to most patients in most circumstances and future research is unlikely to change confidence

Benefits > Risks/Burdens (or vice versa)

Net benefit (or net harm) is substantial

Applies to most patients in most circumstances but better evidence could change confidence

 

Benefits > Risks/Burdens (or vice versa)

Net benefit (or net harm) appears substantial

Applies to most patients in most circumstances but better evidence is likely to change confidence

(rarely used to support a Strong Recommendation)

Moderate Recommendation

 

(Net benefit or harm moderate)

Benefits > Risks/Burdens (or vice versa)

Net benefit (or net harm) is moderate

Applies to most patients in most circumstances and future research is unlikely to change confidence

Benefits > Risks/Burdens (or vice versa)

Net benefit (or net harm) is moderate

Applies to most patients in most circumstances but better evidence could change confidence

Benefits > Risks/Burdens (or vice versa)

Net benefit (or net harm) appears moderate

Applies to most patients in most circumstances but better evidence is likely to change confidence

Conditional Recommendation

 

(No apparent net benefit or harm)

Benefits = Risks/Burdens

Best action depends on individual patient circumstances

Future research unlikely to change confidence

Benefits = Risks/Burdens

Best action appears to depend on individual patient circumstances

Better evidence could change confidence

Balance between Benefits & Risks/Burdens unclear

Alternative strategies may be equally reasonable

Better evidence likely to change confidence

Clinical Principle

A statement about a component of clinical care that is widely agreed upon by urologists or other clinicians for which there may or may not be evidence in the medical literature

Expert Opinion

A statement, achieved by consensus of the Panel, that is based on members' clinical training, experience, knowledge, and judgment for which there is no evidence

Process. The Surgical Management of Female Stress Urinary Incontinence Panel was created in 2014 by the American Urological Association Education and Research, Inc. (AUA). 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. The AUA conducted a thorough peer review process. 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 (S&Q). It was then submitted to the AUA and SUFU Boards of Directors for final approval. Panel members received no remuneration for their work.

Background

SUI is a common problem experienced by women. 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.6-8While many women choose surgical management for their SUI, the specific options for surgical treatment have evolved over time.9 The first AUA Female SUI Guidelines Panel reviewed available literature up to 1994 while the literature search for the SUI Guidelines Panel that directly preceded the present iteration concluded in June 2005.10 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 iterations of the SUI guidelines, is an otherwise healthy female who is considering surgical therapy for the correction of pure stress and/or stress-predominant mixed urinary incontinence (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 of SUI do not meet the definition of the index patient. In fact, most of the studies in the literature do not enroll patients based on this definition of the 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 the 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.

Patient Evaluation

Guideline Statement 1

In the initial evaluation of patients with stress urinary incontinence desiring to undergo surgical intervention, physicians should include the following components: (Clinical Principle)

  • Focused history, including assessment of bother
  • Focused physical examination, including a pelvic examination
  • Objective demonstration of stress urinary incontinence with a comfortably full bladder(any method)
  • Assessment of post-void residual urine (any method)
  • Urinalysis

Guideline Statements 1-3 Below


Guideline Statement 2

Physicians 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 stress urinary incontinence
  • Known or suspected neurogenic lower urinary tract dysfunction
  • Abnormal urinalysis, such as unexplained hematuria or pyuria
  • Urgency-predominant mixed urinary incontinence
  • Elevated post-void residual per clinician judgment
  • High grade pelvic organ prolapse (POP-Q stage 3 or higher) if stress urinary incontinence not demonstrated by pelvic organ prolapse reduction
  • Evidence of significant voiding dysfunction

Guideline Statements 1-3 Below


Guideline Statement 3

Physicians 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

Guideline Statements 1-3 Below


Discussion for Guideline Statements 1-3

The purpose of the diagnostic evaluation in the incontinent woman is to document, confirm, and characterize SUI; to assess the differential diagnosis and comorbidities; and to prognosticate and aid in the selection of treatment. The first goal of the diagnostic evaluation is to confirm the diagnosis of SUI and optimally characterize the incontinence. The literature search regarding the optimal evaluation for the index patient yielded two systematic reviews11,12 and four individual studies that addressed this issue.13-16The role of six variables was assessed: history, questionnaires/scales, stress test, Q-tip test, pad test, and urodynamics. Additional tests, including urinalysis, pelvic examination, prolapse assessment, cystoscopy, PVR volume, and voiding diary, yielded no additional meaningful evidence.

History. Holroyd-Leduc et al. performed a moderate-quality systematic review of various methods for diagnosing urinary incontinence during office assessment.11 A meta-analysis of 10 cohort studies with 2,657 patients found that the presence of coughing, sneezing, lifting, walking, or running as initiators of incontinence increased the likelihood of SUI as the cause of urinary leakage, while their absence decreased the likelihood of SUI. Thus, a woman with a positive clinical history had a 74% chance of having SUI, whereas a woman with a negative clinical history had a 34% chance of having SUI. Likewise, in a systematic review by Martin et al. that combined data from 15 cohort studies with 3,545 patients, a woman with a positive clinical history had a 73% chance of having SUI, whereas a woman with a negative clinical history had a 16% chance of having SUI.12 Thus, the evidence from two moderate-quality meta-analyses suggests that clinical history provides some diagnostic value for patients with signs/symptoms potentially caused by SUI; however, history alone, while helpful, does not definitively diagnose SUI in women.

Questionnaires. Eight questionnaires were assessed in the two systematic reviews for their ability to diagnose SUI.11,12 While most questionnaires showed small positive and negative likelihood ratios (LRs) for diagnosing or ruling out SUI, the limited number of studies for each questionnaire resulted in an overall strength of evidence of low. It is important to note that an assessment of bother, regardless of method or questionnaire, is paramount to the decision to operate in the index patient. Since SUI is a condition that impacts QOL (rather than quantity of life), the treatment decisions should be closely linked to the ability to improve bother caused by the symptoms. If bother is minimal, then strong consideration should be given to non-surgical management.

Stress test. Two moderate-quality systematic reviews and one additional study evaluated stress tests for diagnosis of SUI using urodynamic evaluations as the reference standard. While stress tests were performed under different protocols (e.g. retrograde filling with 200 mL saline; 20 minutes after catheterization for PVR volume), a positive stress test had a high sensitivity and specificity for detecting SUI on urodynamics. Similar results were obtained in a single study that combined the supine and standing stress test.17However, since this combined test was evaluated in only one study, the strength of evidence supporting it is low. Additionally, in a secondary analysis of an RCT by Albo et al., the sensitivity and specificity of the supine empty bladder stress test to predict ISD were 49% and 60%, respectively, suggesting that the supine stress test did not identify ISD.13

Q-tip test. Holroyd-Leduc et al. included two studies with a total of 253 patients that evaluated the Q-tip test, with one study using a cutoff angle of 20° and the other 35°.11  Both studies used urodynamic tests as the reference standard and the pooled positive LR was very small, suggesting that a positive test is unlikely to aid in the diagnosis of SUI. Intuitively, this makes sense, since SUI may exist without urethral hypermobility and vice versa. Thus, moderate strength evidence suggests that a positive Q-tip test has little value for diagnosis of SUI, and this test cannot be recommended by the panel to diagnose SUI. However, it can provide some potentially useful information regarding the degree of urethral mobility.

Pad test. The review by Holroyd-Leduc et al. included one study with 105 patients (Versi et al.)18 that compared the 48-hour pad test to a reference standard of urodynamic findings. Women with a positive pad test had an 81% chance of having SUI, whereas women with a negative pad test had a 13% chance of having SUI. In this study, however, all patients had either SUI or no incontinence. Thus, the authors concluded that “the pad test confirms an incontinence problem, but its role in distinguishing the type of incontinence cannot be commented on.”

Martin et al. included two studies in their analysis.12 One of these was the Versi study, while the study by Jorgensen et al.19 compared the one-hour pad test to a reference standard of urodynamic findings. The latter study showed a high sensitivity (94%) but low specificity (44%) for diagnosing SUI. These results correspond to women with a positive pad test having a 69% chance of having SUI, and women with a negative pad test having a 15% chance of having SUI. Since each test was evaluated by only one small study, the strength of evidence for both tests is low, and importantly, though a pad test may confirm the presence of incontinence, it does not distinguish the specific type of incontinence.

After performing a history and physical  examination, including a pelvic examination with a comfortably full bladder, the diagnosis of SUI may be fairly straightforward in the index patient. The sine-qua-non for a definitive diagnosis is a positive stress test, or witnessing of involuntary urine loss from the urethral meatus coincident with increased abdominal pressure, such as occurs with coughing and Valsalva maneuver. If leakage is not witnessed in the supine position, the test may be repeated in the standing position to facilitate the diagnosis. Once the increase in abdominal pressure has subsided, flow through the urethra should subside as well. Rarely, one may witness urine loss after an increase in intra-abdominal pressure has subsided. In this scenario, the incontinence may be, at least in part, due to an involuntary detrusor contraction (stress-induced detrusor overactivity).

The Panel felt that physicians should obtain the following details from the history, bladder diary, questionnaires, and/or pad testing.

  • Characterization of incontinence (stress, urgency, mixed, continuous, without sensory awareness)
  • Chronicity of symptoms
  • Frequency, bother, and severity of incontinence episodes
  • Patient’s expectations of treatment (patient-centered goals)
  • Pad or protection use
  • Concomitant urinary tract symptoms (e.g., urgency, frequency, nocturia, dysuria, hematuria, slow flow, hesitancy, incomplete emptying)
  • Concomitant pelvic symptoms (e.g., pelvic pain, pressure, bulging, dyspareunia)
  • Concomitant gastrointestinal symptoms (e.g., constipation, diarrhea, splinting to defecate)
  • Obstetric history (e.g., gravity, parity, method of delivery)
  • Previous treatments for incontinence (e.g., behavioral therapy, Kegel exercises/pelvic floor muscle training, pharmacotherapy, surgery)
  • Previous pelvic surgeries
  • Past medical history (e.g., hypertension, diabetes, history of pelvic radiation)
  • Current and past medications
  • Fluid, alcohol, and caffeine intake
  • Menopausal status 

Additionally, the physical examination of the index or non-index patient should include the following components:

  • Focused abdominal examination
  • Evaluation of urethral mobility (any method)
  • Supine and/or standing stress test with comfortably full bladder
  • Assessment of pelvic prolapse (any method)
  • Assessment of vaginal atrophy/estrogenization status
  • Focused neurologic examination 

Diagnostic evaluations that should be performed in the index or non-index patient include the following:

  • Urinalysis
  • PVR

The presence of microscopic hematuria may warrant additional evaluation with upper tract imaging and cystoscopy. The assessment of PVR may alert the physician to the potential for incomplete bladder emptying. Several points deserve mention. First, the reliability of a single elevated PVR value for predicting emptying dysfunction remains in question, just as a single low PVR value does not rule out the presence of incomplete emptying. Second, the threshold value of a significant PVR is similarly undefined. Finally, a persistently elevated PVR does not characterize the cause of impaired emptying, but rather indicates the need for further evaluation. Additionally, an elevated PVR in the presence of SUI may impact patient counseling regarding surgical interventions and patient expectations. Elevated PVR may be an indication of hypocontractility of the bladder and may put a patient at risk for retention after treatment for SUI. Consideration of the relationship between incomplete bladder emptying and UTI should be considered, and a urinalysis with culture as indicated should be obtained in patients with elevated PVR in the face of symptoms of a UTI.

The second goal of a diagnostic evaluation in a woman with SUI is to assess the differential diagnosis of incontinence and evaluate the impact of coexisting conditions. The differential diagnosis of SUI includes other causes of urethral incontinence, such as overflow incontinence (a clinical diagnosis) and detrusor overactivity incontinence, low bladder compliance, and stress-induced detrusor overactivity (urodynamic diagnoses). Other anatomic findings such as pelvic organ prolapse and number and location of ureteral orifices can be diagnosed by physical examination and cystoscopy, respectively. Similarly, additional functional conditions, such as urethral obstruction and impaired or absent contractility, can be identified via urodynamics testing, including cystometry, non-invasive uroflow, pressure-flow study, and PVR assessment. Urinary incontinence may also occur due to a urethral diverticulum, a urinary fistula, or an ectopic ureter. These entities are often suspected on the basis of history and examination, but generally require cystoscopy and other urinary tract imaging for confirmation.

Certain coexistent conditions may influence surgical technique, impact the outcomes of treatment, and influence the nuances of patient counseling. For example, a patient with MUI who has a large PVR volume and detrusor underactivity might be counseled that her urgency symptoms may persist and that there is a potential for urinary retention following surgical treatment of SUI. Furthermore, surgical technique might be tailored based on some anatomic features and the presence of concomitant urinary urgency and UUI.

The third goal of the diagnostic evaluation is to aid in prognosis and selection of treatment. There are few facts and many opinions about predicting the outcome of surgery based on the conditions described above. However few clinicians would disagree that operations for SUI should be confined to those who have demonstrable SUI, including occult SUI demonstrable only after reduction of pelvic organ prolapse. Nevertheless, an understanding of the specific concomitant conditions facilitates individualized treatment planning and informed consent. It also provides the surgeon information with which to formulate a sense regarding potential outcome and possible complications such as incomplete bladder emptying, persistent, worsened, or de novo urgency/UUI, and recurrent sphincteric incontinence. Urodynamic evaluation may be of assistance in elucidating complex presentations of incontinence.

Additional evaluation should also be performed in women with suspected neurogenic etiology for their incontinence or in women with evidence of dysfunctional voiding. Women who present with persistent or recurrent SUI after previous definitive surgical intervention may also benefit from additional evaluation. Likewise, in select patients with symptomatic SUI in whom SUI cannot be demonstrated, additional evaluation may be beneficial. It must be mentioned that the need for further evaluation of any given patient depends upon a number of additional factors, including the physician’s degree of certainty and comfort regarding the accuracy of the diagnosis, the degree of bother the symptoms are causing the patient, the impact that further studies will have on diagnosis, and treatment risks, options, and likely outcomes. The desire and willingness of the patient to undergo further studies should also be taken into consideration.

Cystoscopy & Urodynamics Testing

Guideline Statement 4

Physicians should not perform cystoscopy in index patients for the evaluation of stress urinary incontinence unless there is a concern for urinary tract abnormalities. (Clinical Principle)

Discussion


Guideline Statement 5

Physicians may omit urodynamic testing for the index patient desiring treatment when stress urinary incontinence is clearly demonstrated. (Conditional Recommendation; Evidence Level: Grade B)

Discussion


Guideline Statement 6

Physicians may perform urodynamic testing in non-index patients. (Expert Opinion)

Discussion


Patient Counseling

Guideline Statement 7

In patients wishing to undergo treatment for stress urinary incontinence, the degree of bother that their symptoms are causing them should be considered in their decision for therapy. (Expert Opinion)

Discussion


Guideline Statement 8

In patients with stress urinary incontinence or stress-predominant mixed urinary incontinence who wish to undergo treatment, physicians 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

Discussion


Guideline Statement 9

Physicians should counsel patients on potential complications specific to the treatment options. (Clinical Principle)

Discussion


Guideline Statement 10

Prior to selecting midurethral synthetic sling procedures for the surgical treatment of stress urinary incontinence in women, physicians must discuss the specific risks and benefits of mesh as well as the alternatives to a mesh sling. (Clinical principle)

Discussion


Treatment

Guideline Statement 11

In patients with stress urinary incontinence or stress-predominant mixed urinary incontinence, physicians may offer the following non-surgical treatment options: (Expert Opinion)

  • Continence pessary
  • Vaginal inserts
  • Pelvic floor muscle exercises

Discussion


Guideline Statement 12

In index patients considering surgery for stress urinary incontinence, physicians may offer the following options: (Strong Recommendation; Evidence Level: Grade A)

  • Midurethral sling (synthetic)
  • Autologous fascia pubovaginal sling
  • Burch colposuspension
  • Bulking agents

Discussion


Guideline Statement 13

In index patients who select midurethral sling surgery, physicians may offer either the retropubic or transobturator midurethral sling. (Moderate Recommendation; Evidence Level: Grade A)

Discussion


Guideline Statement 14

Physicians may offer single-incision slings to index patients undergoing midurethral sling surgery with the patient informed as to the immaturity of evidence regarding their efficacy and safety. (Conditional Recommendation; Evidence Level: Grade B)

Discussion


Guideline Statement 15

Physicians should not place a mesh sling if the urethra is inadvertently injured at the time of planned midurethral sling procedure. (Clinical Principle)

Discussion


Guideline Statement 16

Physicians should not offer stem cell therapy for stress incontinent patients outside of investigative protocols. (Expert Opinion)

Discussion


Special Cases

Guideline Statement 17

In patients with stress urinary incontinence and a fixed, immobile urethra (often referred to as ‘intrinsic sphincter deficiency’) who wish to undergo treatment, physicians should offer pubovaginal slings, retropubic midurethral slings, or urethral bulking agents. (Expert Opinion)

Discussion


Guideline Statement 18

Physicians 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)

Discussion


Guideline Statement 19

Physicians 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)

Discussion


Guideline Statement 20

In patients undergoing concomitant surgery for pelvic prolapse repair and stress urinary incontinence, physicians may perform any of the incontinence procedures (e.g., midurethral sling, pubovaginal sling, Burch colposuspension). (Conditional Recommendation; Evidence Level: Grade C)

Discussion


Guideline Statement 21

Physicians may offer patients with stress urinary incontinence and concomitant neurologic disease affecting lower urinary tract function (neurogenic bladder) surgical treatment of stress urinary incontinence after appropriate evaluation and counseling have been performed. (Expert Opinion)

Discussion


Guideline Statement 22

Physicians 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

Discussion


Outcomes Assessment

Guideline Statement 23

Physicians 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)

Discussion


Guideline Statement 24

Patients should be seen and examined by their physicians 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, 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.

Discussion


Future Direction

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. Expanded use of tests of functional health literacy in adults (TOFHLA) may expedite literacy assessments in unique individuals. 

Improving and honing a physician’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.78 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.

The use of telemedicine in surgery is expanding rapidly and across multiple specialties within surgical disciplines. Telesurgery has been performed for the last several decades, but the use of telemedicine, from a standpoint of mentoring and consultation, has recently become more popular. Although not completely explored, some pelvic floor disorders would appear to be uniquely suited to teleconsultation and telefollow-up for purposes of managing chronic conditions, which these disorders represent.79

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.80-83 Different stem cell populations have been evaluated for this indication. The six cell types include embryonic, muscle-derived (satellite cells), bone marrow-derived,84 mesenchymal, adipose, urinary, and human umbilical cord blood types. Human amniotic fluid stem cells (hAFSCs) have also been proposed. 85,86

Autologous muscle-derived cells (AMDSC) have been evaluated for intrasphincteric injection for SUI.87 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 three-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.

Tools and Resources

Patient Resources

References

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For more educational resources, patient brochures and algorithms, click Tools and Resources on the left sidebar (desktop computers only).