76. Panel members were selected by the chair. Q-tip test. Ford et al.20 performed a meta-analysis that included 10 trials with a total of 1,463 women with SUI or MUI with stress- predominant symptoms that compared the outside-in and inside-out TMUS. Treatment related complications included minor events such as pain/bruising at the biopsy and injection sites. Adverse events were different with vaginal perforation occurring more frequently with the outside-in approach and voiding dysfunction occurring more frequently with the inside-out approach. There were fewer and less robust studies with medium term (1-5 years) and long-term (>5 years) follow-up with subjective cure rates ranging from 43-92% for TMUS and 51-88% for RMUS. Athanasopoulos A, Gyftopoulos K and McGuire EJ: Efficacy and preoperative prognostic factors of autologous fascia rectus sling for treatment of female stress urinary incontinence. The guideline text may include information or recommendations about certain drug uses ('off label') that are not approved by the Food and Drug Administration (FDA), or about medications or substances not subject to the FDA approval process. Additionally, the physical examination of the index or non-index patient should include the following components: Diagnostic evaluations that should be performed in the index or non-index patient include the following: The presence of microscopic hematuria may warrant additional evaluation with upper tract imaging and cystoscopy. 56. The multi-incision sling procedure can be performed using three incisions, in two ways: with one vaginal incision and two lower abdominal incisions, called retropubic; or with one vaginal incision and two groin/thigh incisions, called transobturator. The guideline’s main aim is to help women choose which management option for urinary incontinence (UI) and pelvic organ prolapse (POP) is right for them, with a clear focus on the woman’s choice. 1) Stress Incontinence – is an involuntary loss of urine due to an increased intra-abdominal pressure during coughing, sneezing, laughing or other physical activities that increase intra-abdominal pressure. The common types of urinary incontinence in older people are stress incontinence and urge incontinence. However, the recommendations in these guidelines formulated by different organisations and countries are inconsistent. What are the pros and cons of using a mesh sling in my particular case? The weakened sphincter muscle is not able to stop the flow of urine under normal circumstances and when there is an increase in abdominal pressure. Retreatment tends to be the norm for bulking agent therapy, and determination of absolute outcomes accordingly becomes challenging. Int Urogynecol J Pelvic Floor Dysfunct 2015;26:213. 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. (Moderate Recommendation; Evidence Level: Grade A). Conditional Recommendations also can be supported by any evidence strength. While stress tests were performed under different protocols (e.g. Results: The AUA (American Urological Association) and SUFU (Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction) have formulated an evidence-based guideline focused on the surgical treatment of female stress urinary incontinence in both index and non-index patients. While they did not show any differences in subjective or objective cure rates, the confidence intervals were too large to rule out a significant difference. Rarely, one may witness urine loss after an increase in intra-abdominal pressure has subsided. How likely is it that my repair could be successfully performed without using a mesh sling? 28. Treating physicians must take into account variations in resources, and patient tolerances, needs, and preferences. Most studies comparing the top-down to the bottom-up technique demonstrated equivalence or were inconclusive. However, long-term comparisons are relatively lacking. That being said, robust long-term data are lacking, and the data from increasing follow up appear to be demonstrating a lack of durability of TMUS versus RMUS. The urethra or bladder neck is supported with either stitches alone or with tissue surgically removed from other parts of the body such as the abdominal wall or leg (fascial sling), with tissue from another person (donor tissue) or with material such as surgical mesh (mesh sling). 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. (Expert Opinion). Generally, outcomes were based on a set of variables such as stress tests, patient reports, and the need for retreatment. For diagnostic cohort studies, analysts used the QUADAS-2 instrument. 24. If mesh erosion occurs through the vaginal tissue, it is possible that men may experience penile irritation and/or pain during sexual intercourse. 17. Patients should be aware that with any intervention there is a risk of continued symptoms of SUI immediately after the procedure or recurrent SUI at a later time that may require further intervention. 16. What surgical or non-surgical treatment options are available and what do you recommend to treat my SUI? Ford et al.20 found more major vascular or visceral injuries, bladder or urethral perforations, voiding dysfunction, and suprapubic pain with the RMUS, while groin pain, repeat incontinence surgery between one and five years, and repeat incontinence surgery after more than five years were more likely to occur with the TMUS. If the patient expresses minimal subjective bother due to the SUI, then strong consideration should be given to conservative, non–surgical therapy. Bjelic-Radisic V, Dorfer M, Tamussino K et al: The Incontinence Outcome Questionnaire: an instrument for assessing patient-reported outcomes after surgery for stress urinary incontinence. Though clearly this communication can be in person, there is no evidence that a phone discussion cannot provide the same information.70 Recent evidence would suggest that verbal communication potentially supplemented by live internet-based communication (tele-medicine) of wounds can suffice for follow up evaluation in uncomplicated post-operative scenarios and can identify surgical complications expeditiously when present.71 If patients are having voiding dysfunction, a decrease in the force of their urinary stream, unexpected pain, recurrent UTI, new onset dyspareunia, or other unanticipated symptoms, they should be evaluated in person by the physician or his/her designee. Validated QOL and incontinence severity measures were assessed by Fan et al.35 in seven RCTs that compared RMUS (TVT) and TMUS (TVT-O). In July 2018, the Government announced a period of ‘high vigilance restriction’ on the use of a group of procedures to treat stress urinary incontinence and pelvic organ prolapse, in England. The SISTEr trial compared the Burch colposuspension with the autologous fascial PVS. If I have a complication related to the mesh sling, how likely is it that the complication can be resolved? In one study, data regarding four specific adverse events favored TMUS over SIS: less vaginal mesh exposure, less mesh perforation into the bladder or urethra, greater need for repeat SUI surgery, and greater need for any other additional or new surgical procedure. Single incision synthetic sling (SIS). 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. Urology 2011; 78: 1034. The meta-analysis by Ford et al.20 also demonstrated a significantly higher rate of repeat incontinence surgery within five years in the TMUS group. Four additional RCTs of moderate and high quality were consistent with the conclusion of equivalence between the two approaches.39,48-51. Additionally, analysts compared bottom-up versus top-down RMUS, as well as outside-in versus inside-out transobturator midurethral slings (TMUS). Wadie BS and Elhefnawy AS: TVT versus TOT, 2-year prospective randomized study. 14. ce happens when physical movement or activity — such as coughing, sneezing, running or heavy lifting — puts pressure (stress) For more educational resources, patient brochures and algorithms, click Tools and Resources on the left sidebar (desktop computers only). Urodynamic evaluation may be of assistance in elucidating complex presentations of incontinence. (Clinical principle). While exposure can be identified visually during a half-speculum exam palpation of the anterior vaginal wall may also identify mesh exposure that is not easily visible. Foote54 and Schellart et al.55 also found less pain with the MiniArc SIS versus the TMUS and inconclusive results for other adverse events. 51. 70. Data suggested effectiveness and need for retreatment favoring the fascial sling over the Burch colposuspension (66% versus 49%). 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. A prospective randomized controlled study. (Expert Opinion). However, if these patients elect surgical therapy, intraoperative cystoscopy should be performed with certain surgical procedures (e.g., midurethral or pubovaginal fascial slings) to confirm the integrity of the lower urinary tract and the absence of foreign body within the bladder or urethra. The subjective outcome of surgery as perceived by the patient should be assessed and documented. While most other adverse events outcomes were inconclusive due to wide confidence intervals, de novo urgency or UUI were equivalent between the two procedures. The clinical practice guidelines on urinary incontinence were released in April 2018 by the European Association of Urology. An update abstract search was conducted through September 2016, which pulled in an additional 66 abstracts related to the key questions of interest. 1 Evidence profile: urinary incontinence ICOPE guidelines – World Health Organization Background Urinary incontinence, the involuntary loss of urine, is a highly prevalent condition in older people aged 60 years and over (1). This detailed discussion should make clear to the patient the possible risks, benefits, and alternatives of MUS. Stress Urinary Incontinence (SUI) is the leaking of urine during activities that increase pressure inside the abdomen and push down on the bladder, such as coughing, sneezing, running, or heavy lifting. In this study, however, all patients had either SUI or no incontinence. 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), 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, Failure of prior anti-incontinence surgery, Pelvic floor muscle training (± biofeedback), Other non-surgical options (e.g., continence pessary), Physicians should not place a mesh sling if the urethra is inadvertently injured at the time of planned midurethral sling procedure. Additionally, in circumstances of preoperative concern related to postoperative voiding dysfunction (e.g. The Panel felt that physicians should obtain the following details from the history, bladder diary, questionnaires, and/or pad testing. Assessing risk of bias in included studies. Each member of the Panel provides an ongoing conflict of interest disclosure to the AUA. J Urol 2008; 179:1024. Whiting PF, Rutjes AW, Westwood ME et al: QUADAS-2: A revised tool for the quality assessment of diagnostic accuracy studies. Although most of these procedures have been available for some time, very little comparative data between these broad treatment categories exists to assist the physician in choosing a therapy. Any surgery for SUI may put you at risk for complications, including additional surgery. 79. Clinical guideline [CG171]Published: 11 September 2013Last updated: 05 November 2015. Stress Incontinence is urinary incontinence during physical activities that increase intra-abdominal pressure, such as coughing, sneezing, or lifting. In such cases, alternatives to synthetic mesh should be considered, although there is no direct evidence that patients are at increased risk of urethral perforation in these circumstances. (Conditional Recommendation; Evidence Level: Grade B). 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). Int Urogynecol J Pelvic Floor Dysfunct 2011;22:1241. However, it can provide some potentially useful information regarding the degree of urethral mobility. Overall, however, some early short-term data suggested equivalence in incontinence rates after surgery when comparing TMUS to RMUS in both index and non-index patients. 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. Ther Adv Urol 2015; 7: 22. Schweitzer KJ, Milani AL, Van Eijndhoven HW et al: Postoperative pain after adjustable single-incision or transobturator sling for incontinence: a randomized controlled trial. For patient factors predicting outcomes, analysts used the Quality in Prognostic Studies (QUIPS) tool. Ballester M, Bui C, Frobert JL et al: Four-year functional results of the suburethral sling procedure for stress urinary incontinence: a French prospective randomized multicentre study comparing the retropubic and transobturator routes. Holroyd-Leduc et al. Urology 2011; 77:1070. Richter HE, Albo ME, Zyczynski HM et al: Retropubic versus transobturator midurethral slings for stress incontinence. Informed patient decision-making is critical in this situation. World J Urol 2013; 31:645. Your appointment will likely include a: 1. Urology 2011;77:55. 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. Of the remaining seven trials, two found equivalence,41,44 four were inconclusive,43,45-47 and one43 indicated an advantage of RMUS. What Questions Should I Ask My Surgeon If I am Considering Surgery to Treat Stress Urinary Incontinence? Patients with unfavorable outcomes may require additional follow-up. This document was written by the Stress Urinary Incontinence Guideline Panel of the American Urological Association Education and Research, Inc., which was created in 2014. 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. Dissaranan C, Cruz MA, Couri BM et al: Stem cell therapy for incontinence: where are we now? 34. Mixed incontinence refers to a combination of SUI and UUI. Eur J Obstet Gynecol Reprod Biol 2011; 157:226. Schierlitz L, Dwyer PL, Rosamilia A et al: Three-year follow-up of tension-free vaginal tape compared with transobturator tape in women with stress urinary incontinence and intrinsic sphincter deficiency. In light of the elective nature of the surgery, the Panel suggests that in most instances, surgical treatment of SUI should be deferred until after child bearing is complete. (Clinical Principle), 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). 53.