Mid-urethral sling operations for stress urinary incontinence in women.

BACKGROUND: Urinary incontinence is a very common and debilitating problem affecting about 50% of women at some point in their lives. Stress urinary incontinence (SUI) is a predominant cause in 30% to 80% of these women imposing significant health and economic burden on society and the women affected. Mid-urethral sling (MUS) operations are a recognised minimally invasive surgical treatment for SUI. MUS involves the passage of a small strip of tape through either the retropubic or obturator space, with entry or exit points at the lower abdomen or groin, respectively. This review does not include single-incision slings. OBJECTIVES: To assess the clinical effects of mid-urethral sling (MUS) operations for the treatment of SUI, urodynamic stress incontinence (USI) or mixed urinary incontinence (MUI) in women. SEARCH METHODS: We searched: Cochrane Incontinence Specialised Register (including: CENTRAL, MEDLINE, MEDLINE In-Process, ClinicalTrials.gov) (searched 26 June 2014); Embase Classic (January 1947 to Week 25 2014); WHO ICTRP (searched 30 June 2014); reference lists. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials amongst women with SUI, USI or MUI, in which both trial arms involve a MUS operation. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the methodological quality of potentially eligible studies and extracted data from included trials. MAIN RESULTS: We included 81 trials that evaluated 12,113 women. We assessed the quality of evidence for outcomes using the GRADE assessment tool; the quality of most outcomes was moderate, mainly due to risk of bias or imprecision.Fifty-five trials with data contributed by 8652 women compared the use of the transobturator route (TOR) and retropubic route (RPR). There is moderate quality evidence that in the short term (up to one year) the rate of subjective cure of TOR and RPR are similar (RR 0.98, 95% CI 0.96 to 1.00; 36 trials, 5514 women; moderate quality evidence) ranging from 62% to 98% in the TOR group, and from 71% to 97% in the RPR group. Short-term objective cure was similar in the TOR and RPR groups (RR 0.98, 95% CI 0.96 to 1.00; 40 trials, 6145 women). Fewer trials reported medium-term (one to five years) and longer-term (over five years) data, but subjective cure was similar between the groups (RR 0.97, 95% CI 0.87 to 1.09; 5 trials, 683 women; low quality evidence; and RR 0.95, 95% CI 0.80 to 1.12; 4 trials, 714 women; moderate quality evidence, respectively). In the long term, subjective cure rates ranged from 43% to 92% in the TOR group, and from 51% to 88% in the RPR group.MUS procedures performed using the RPR had higher morbidity when compared to TOR, though the overall rate of adverse events remained low. The rate of bladder perforation was lower after TOR (0.6% versus 4.5%; RR 0.13, 95% CI 0.08 to 0.20; 40 trials, 6372 women; moderate quality evidence). Major vascular/visceral injury, mean operating time, operative blood loss and length of hospital stay were lower with TOR.Postoperative voiding dysfunction was less frequent following TOR (RR 0.53, 95% CI 0.43 to 0.65; 37 trials, 6200 women; moderate quality evidence). Overall rates of groin pain were higher in the TOR group (6.4% versus 1.3%; RR 4.12, 95% CI 2.71 to 6.27; 18 trials, 3221 women; moderate quality evidence) whereas suprapubic pain was lower in the TOR group (0.8% versus 2.9%; RR 0.29, 95% CI 0.11 to 0.78); both being of short duration. The overall rate of vaginal tape erosion/exposure/extrusion was low in both groups: 24/1000 instances with TOR compared with 21/1000 for RPR (RR 1.13, 95% CI 0.78 to 1.65; 31 trials, 4743 women; moderate quality evidence). There were only limited data to inform the need for repeat incontinence surgery in the long term, but it was more likely in the TOR group than in the RPR group (RR 8.79, 95% CI 3.36 to 23.00; 4 trials, 695 women; low quality evidence).A retropubic bottom-to-top route was more effective than top-to-bottom route for subjective cure (RR 1.10, 95% CI 1.01 to 1.19; 3 trials, 477 women; moderate quality evidence). It incurred significantly less voiding dysfunction, and led to fewer bladder perforations and vaginal tape erosions.Short-and medium-term subjective cure rates between transobturator tapes passed using a medial-to-lateral as opposed to a lateral-to-medial approach were similar (RR 1.00, 95% CI 0.96 to 1.06; 6 trials, 759 women; moderate quality evidence, and RR 1.06, 95% CI 0.91 to 1.23; 2 trials, 235 women; moderate quality evidence). There was moderate quality evidence that voiding dysfunction was more frequent in the medial-to-lateral group (RR 1.74, 95% CI 1.06 to 2.88; 8 trials, 1121 women; moderate quality evidence), but vaginal perforation was less frequent in the medial-to-lateral route (RR 0.25, 95% CI 0.12 to 0.53; 3 trials, 541 women). Due to the very low quality of the evidence, it is unclear whether the lower rates of vaginal epithelial perforation affected vaginal tape erosion (RR 0.42, 95% CI 0.16 to 1.09; 7 trials, 1087 women; very low quality evidence). AUTHORS' CONCLUSIONS: Mid-urethral sling operations have been the most extensively researched surgical treatment for stress urinary incontinence (SUI) in women and have a good safety profile. Irrespective of the routes traversed, they are highly effective in the short and medium term, and accruing evidence demonstrates their effectiveness in the long term. This review illustrates their positive impact on improving the quality of life of women with SUI. However, a brief economic commentary (BEC) identified three studies suggesting that transobturator may be more cost-effective compared with retropubic. Fewer adverse events occur with employment of a transobturator approach with the exception of groin pain. When comparing transobturator techniques of a medial-to-lateral versus a lateral-to-medial insertion, there is no evidence to support the use of one approach over the other. However, a bottom-to-top route was more effective than top-to-bottom route for retropubic tapes.A salient point illustrated throughout this review is the need for reporting of longer-term outcome data from the numerous existing trials. This would substantially increase the evidence base and provide clarification regarding uncertainties about long-term effectiveness and adverse event profile.

Mid-urethral sling operations for stress urinary incontinence in women.

BACKGROUND: Urinary incontinence is a very common and debilitating problem affecting about 50% of women at some point in their lives. Stress urinary incontinence (SUI) is a contributory or predominant cause in 30% to 80% of these women. Mid-urethral sling (MUS) operations are a recognised minimally invasive surgical treatment for SUI. MUS involves the passage of a small strip of tape through either the retropubic or obturator space, with entry or exit points at the lower abdomen or groin, respectively. This review does not include single incision slings. OBJECTIVES: To assess the clinical effects of mid-urethral sling (MUS) operations for the treatment of stress urinary incontinence (SUI), urodynamic stress incontinence (USI) or mixed urinary incontinence (MUI) in women. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from CENTRAL, MEDLINE, MEDLINE in process, ClinicalTrials.gov and handsearching of journals and conference proceedings (searched 26 June 2014), Embase and Embase Classic (January 1947 to Week 25 2014), WHO ICTRP (searched on 30 June 2014) and the reference lists of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials amongst women with SUI, USI or MUI, in which both trial arms involve a MUS operation. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the methodological quality of potentially eligible studies and extracted data from the included trials. MAIN RESULTS: We included 81 trials that evaluated 12,113 women. We assessed the quality of evidence for outcomes using the GRADE assessment tool; the quality of most outcomes was moderate, mainly due to risk of bias or imprecision.Fifty-five trials with data contributed by 8652 women compared the use of the transobturator route (TOR) and retropubic route (RPR). There is moderate quality evidence that in the short term (up to one year) the rate of subjective cure of TOR and RPR are similar (RR 0.98, 95% CI 0.96 to 1.00; 36 trials, 5514 women; moderate quality evidence) ranging from 62% to 98% in the TOR group, and from 71% to 97% in the RPR group. Short-term objective cure was similar in the TOR and RPR groups (RR 0.98, 95% CI 0.96 to 1.00; 40 trials, 6145 women). Fewer trials reported medium-term (one to five years) and longer-term (over five years) data, but subjective cure was similar between the groups (RR 0.97, 95% CI 0.87 to 1.09; 5 trials, 683 women; low quality evidence; and RR 0.95, 95% CI 0.80 to 1.12; 4 trials, 714 women; moderate quality evidence, respectively). In the long term, subjective cure rates ranged from 43% to 92% in the TOR group, and from 51% to 88% in the RPR group.MUS procedures performed using the RPR had higher morbidity when compared to TOR, though the overall rate of adverse events remained low. The rate of bladder perforation was lower after TOR (0.6% versus 4.5%; RR 0.13, 95% CI 0.08 to 0.20; 40 trials, 6372 women; moderate quality evidence). Major vascular/visceral injury, mean operating time, operative blood loss and length of hospital stay were lower with TOR.Postoperative voiding dysfunction was less frequent following TOR (RR 0.53, 95% CI 0.43 to 0.65; 37 trials, 6200 women; moderate quality evidence). Overall rates of groin pain were higher in the TOR group (6.4% versus 1.3%; RR 4.12, 95% CI 2.71 to 6.27; 18 trials, 3221 women; moderate quality evidence) whereas suprapubic pain was lower in the TOR group (0.8% versus 2.9%; RR 0.29, 95% CI 0.11 to 0.78); both being of short duration. The overall rate of vaginal tape erosion/exposure/extrusion was low in both groups: 24/1000 instances with TOR compared with 21/1000 for RPR (RR 1.13, 95% CI 0.78 to 1.65; 31 trials, 4743 women; moderate quality evidence). There were only limited data to inform the need for repeat incontinence surgery in the long term, but it was more likely in the TOR group than in the RPR group (RR 8.79, 95% CI 3.36 to 23.00; 4 trials, 695 women; low quality evidence).A retropubic bottom-to-top route was more effective than top-to-bottom route for subjective cure (RR 1.10, 95% CI 1.01 to 1.19; 3 trials, 477 women; moderate quality evidence). It incurred significantly less voiding dysfunction, and led to fewer bladder perforations and vaginal tape erosions.Short-and medium-term subjective cure rates between transobturator tapes passed using a medial-to-lateral as opposed to a lateral-to-medial approach were similar (RR 1.00, 95% CI 0.96 to 1.06; 6 trials, 759 women; moderate quality evidence, and RR 1.06, 95% CI 0.91 to 1.23; 2 trials, 235 women; moderate quality evidence). There was moderate quality evidence that voiding dysfunction was more frequent in the medial-to-lateral group (RR 1.74, 95% CI 1.06 to 2.88; 8 trials, 1121 women; moderate quality evidence), but vaginal perforation was less frequent in the medial-to-lateral route (RR 0.25, 95% CI 0.12 to 0.53; 3 trials, 541 women). Due to the very low quality of the evidence, it is unclear whether the lower rates of vaginal epithelial perforation affected vaginal tape erosion (RR 0.42, 95% CI 0.16 to 1.09; 7 trials, 1087 women; very low quality evidence). AUTHORS' CONCLUSIONS: Mid-urethral sling operations have been the most extensively researched surgical treatment for stress urinary incontinence (SUI) in women and have a good safety profile. Irrespective of the routes traversed, they are highly effective in the short and medium term, and accruing evidence demonstrates their effectiveness in the long term. This review illustrates their positive impact on improving the quality of life of women with SUI. With the exception of groin pain, fewer adverse events occur with employment of a transobturator approach. When comparing transobturator techniques of a medial-to-lateral versus a lateral-to-medial insertion, there is no evidence to support the use of one approach over the other. However, a bottom-to-top route was more effective than top-to-bottom route for retropubic tapes.A salient point illustrated throughout this review is the need for reporting of longer-term outcome data from the numerous existing trials. This would substantially increase the evidence base and provide clarification regarding uncertainties about long-term effectiveness and adverse event profile.

Women's perspective: intra-detrusor botox versus sacral neuromodulation for overactive bladder symptoms after unsuccessful anticholinergic treatment.

INTRODUCTION AND HYPOTHESIS: Comprehension of women's perspective and reasons for their choice between intra-detrusor botox (botox) and sacral neuromodulation (SNM) after failed anticholinergic treatment for overactive bladder syndrome (OAB) have not been evaluated and reported in the literature. Our voluntary service evaluation survey aimed to determine reasons behind individual patient choice. METHODS: All women were counseled in detail regarding the two treatment options available after failed anticholinergic treatment as per the hospital trust policy. Once the decision-making process was completed, they were asked to highlight one or more of the 12 questions within the survey that influenced their decision-making process. RESULTS: Fifty patients, with a mean age of 61.66 years (range 38-82 years) participated in our voluntary survey. Seventy-four per cent chose Botox and 26% chose SNM. In the botox group 54.05% disliked the thought of a foreign body in the back with SNM; 45.94% quoted shorter waiting times and 43.24% said that the quicker onset of benefit (within 3-5 days) with botox compared with SNM (up to 2 weeks) helped to influence their decision towards botox. In the SNM group 61.53% were averse to the potential need for botox to be repeated at variable intervals; 46.15% chose SNM to avoid the risk of urinary retention associated with botox. CONCLUSION: The botox group seemed more likely to need quicker results with easy access to the treatment modality, whilst the SNM group seemed keener to focus on a more permanent option with a known interval for the repeat procedure. The difference in patient choice was found to be statistically significant.

Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women.

BACKGROUND: Stress urinary incontinence (SUI) is a common condition affecting up to 30% of women. Minimally invasive synthetic suburethral sling operations are among the latest forms of procedures introduced to treat SUI. OBJECTIVES: To assess the effects of minimally invasive synthetic suburethral sling operations for treatment of SUI, urodynamic stress incontinence (USI) or mixed urinary incontinence (MUI) in women. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Register (searched 20 March 2008), MEDLINE (January 1950 to April 2008), EMBASE (January 1988 to April 2008), CINAHL (January 1982 to April 2008), AMED (January 1985 to April 2008), the UK National Research Register, ClinicalTrials.gov, and reference lists of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials amongst women with SUI, USI or symptoms of stress or mixed urinary incontinence, in which at least one trial arm involved a minimally invasive synthetic suburethral sling operations. DATA COLLECTION AND ANALYSIS: Two review authors assessed the methodological quality of potentially eligible studies and independently extracted data from the included trials. MAIN RESULTS: Sixty two trials involving 7101 women were included. The quality of evidence was moderate for most trials. Minimally invasive synthetic suburethral sling operations appeared to be as effective as traditional suburethral slings ( trials, n = 599, Risk Ratio (RR) 1.03, 95% Confidence Interval (CI) 0.94 to 1.13) but with shorter operating time and less post-operative voiding dysfunction and de novo urgency symptoms.Minimally invasive synthetic suburethral sling operations appeared to be as effective as open retropubic colposuspension (subjective cure rate at 12 months RR 0.96, 95% CI 0.90 to 1.03; at 5 years RR 0.91, 95% CI 0.74 to 1.12) with fewer perioperative complications, less postoperative voiding dysfunction, shorter operative time and hospital stay but significantly more bladder perforations (6% versus 1%, RR 4.24, 95% CI 1.71 to 10.52).There was conflicting evidence about the effectiveness of minimally invasive synthetic suburethral sling operations compared to laparoscopic colposuspension in the short term (objective cure, RR 1.15, 95% CI 1.06 to 1.24; subjective cure RR 1.11, 95% CI 0.99 to 1.24). Minimally invasive synthetic suburethral sling operations had significantly less de novo urgency and urgency incontinence, shorter operating time, hospital stay and time to return to daily activities.A retropubic bottom-to-top route was more effective than top-to-bottom route (RR 1.10, 95% CI 1.01 to 1.20; RR 1.06, 95% CI 1.01 to 1.11) and incurred significantly less voiding dysfunction, bladder perforations and tape erosions.Monofilament tapes had significantly higher objective cure rates (RR 1.15, 95% CI 1.02 to 1.30) compared to multifilament tapes and fewer tape erosions (1.3% versus 6% RR 0.25, 95% CI 0.06 to 1.00).The obturator route was less favourable than the retropubic route in objective cure (84% versus 88%; RR 0.96, 95% CI 0.93 to 0.99; 17 trials, n = 2434), although there was no difference in subjective cure rates. However, there was less voiding dysfunction, blood loss, bladder perforation (0.3% versus 5.5%, RR 0.14, 95% CI 0.07 to 0.26) and shorter operating time with the obturator route. AUTHORS' CONCLUSIONS: The current evidence base suggests that minimally invasive synthetic suburethral sling operations are as effective as traditional suburethral slings, open retropubic colposuspension and laparoscopic colposuspension in the short term but with less postoperative complications. Women were less likely to be continent after operations performed via the obturator (rather than retropubic) route, but they had fewer complications. Most of the trials had short term follow up and the quality of the evidence was variable.

Groin abscess secondary to trans obturator tape erosion: case report and literature review.

AIMS: To report a case of groin abscess secondary to trans obturator tape erosion and review the literature on the incidence, predisposing factors, symptoms and management of tape erosion. METHODS: The clinical history, operative details, postoperative symptoms, findings and management of this case are reported. A thorough literature review of midurethral tape erosions and, in particular, transobturator tape erosions was performed. RESULTS: A 46-year-old woman with urodynamic stress incontinence underwent trans obturator tape insertion. Eight weeks later she developed vaginal discharge and was subsequently diagnosed with a left lateral vaginal wall tape erosion. The eroded section was excised under general anaesthetic. Two weeks later she presented with a large right sided groin abscess which required incision, drainage and debridement of necrotic areas of gracillis and adductor muscles. Short term results following trans obturator tape insertion report excellent efficacy rates (90-96% after 1 year), however there is a lack of long term data on safety and efficacy. Current literature on transobturator tape erosion is scanty and reported rates range from 1.9-7% depending on the tape inserted. Tape erosion commonly presents with vaginal discharge, bleeding or dyspareunia and several methods of management have been reported including conservative management, excision of the eroded section or removal of the entire tape. CONCLUSIONS: Groin abscess following tape erosion is a serious complication resulting in further surgery and months of morbidity for the woman. Prompt management of tape erosion is essential to minimise such complications and more data is required on the long term efficacy and safety of transobturator tapes.

Female sterilisation: a cohort controlled comparative study of ESSURE versus laparoscopic sterilisation.

OBJECTIVE: To compare patient satisfaction, discomfort, procedure time, success rate and adverse events of hysteroscopic (ESSURE, Conceptus Inc, San Carlos, USA) versus laparoscopic sterilisation. DESIGN: Cohort controlled comparative study. SETTING: The day surgery and outpatient unit of three large UK hospitals. POPULATION: Eighty-nine women requesting sterilisation were enrolled into the study. METHODS: A 2:1 ratio of ESSURE placement to laparoscopic sterilisation was undertaken. Laparoscopic sterilisation was carried out under general anaesthesia in the day surgery unit whereas all ESSURE procedures were carried out in a dedicated outpatient facility. All patients completed a self-assessment diary on days 7 and 90 post-operatively. Patient satisfaction, tolerance and discomfort were measured using an ordinal Likert style scale. Data were analysed using the chi(2) test for statistical significance. MAIN OUTCOME MEASURES: The primary outcome measure is patient satisfaction with ESSURE versus laparoscopic sterilisation. This included satisfaction with the decision to proceed with the relevant sterilisation method, recovery from the procedure and overall satisfaction following either ESSURE or laparoscopic sterilisation. Secondary outcome measures include successful completion of procedure, procedure time, tolerance, patient discomfort and post-operative adverse events. RESULTS: All women who underwent laparoscopic sterilisation had the procedure successfully completed whereas the overall bilateral device placement rate for ESSURE was 81%. Patient satisfaction with their decision to undergo either ESSURE or laparoscopic sterilisation was high with 94% of the ESSURE group being 'very' or 'somewhat' satisfied at 90 days post-procedure versus 80% in the laparoscopic sterilisation group. At 90 days post-procedure 100% of women in the ESSURE group were 'very satisfied' with their speed of recovery versus 80% in the laparoscopic sterilisation group. The procedure time (defined from the time of insertion of the hysteroscope or laparoscope to its removal) took significantly longer for ESSURE than laparoscopic sterilisation (mean = 13.2 vs 9.7 minutes, P= 0.045). However, the time required for insertion of a Verres needle and insufflation of the abdominal cavity is a necessary part of the laparoscopic sterilisation and had it been included would bring the procedures times more in line with each other. The mean time spent in hospital was significantly shorter for the ESSURE group than the laparoscopic group (188.7 vs 396.1 minutes, P < 0.005). Eighty-two percent of women in the ESSURE group described their tolerance of the procedure between 'good and excellent' compared with only 41% of the laparoscopic sterilisation group (P= 0.0002). Only 31% of the ESSURE group reported moderate or severe pain following the procedure compared with 63% of the laparoscopic sterilisation group (P= 0.08). Only 11% of patients had problems immediately post-operatively in the ESSURE group compared with 27% in the laparoscopy group. Finally, in the more medium term (three months post-operatively), patients still had an advantage in terms of post-procedure adverse events in the ESSURE group (21%vs 50%). CONCLUSIONS: This study provides evidence that ESSURE can be performed in the majority of women and, when successful, is associated with a greater overall patient satisfaction rate than laparoscopic sterilisation. Women also spend less time in hospital, have better tolerance of the procedure and describe less severe post-operative pain. However, the devices cannot be bilaterally placed in all cases and some women do not tolerate the procedure awake.

A comparison of outpatient hysteroscopy with saline infusion hysterosonography.

OBJECTIVES: To establish the accuracy of saline infusion hysterosonography in diagnosing uterine pathology when compared with outpatient hysteroscopy. DESIGN: Prospective, parallel, blinded comparative study. SETTING: Outpatient hysteroscopy clinic in a large university teaching hospital. POPULATION: All women referred for outpatient hysteroscopy in a 15-month period. INTERVENTIONS: Women underwent saline infusion hysterosonography followed by flexible hysteroscopy. The ultrasonographer was blinded to the hysteroscopy result and the gynaecologist was blinded to the saline infusion hysterosonography result. MAIN OUTCOME MEASURES: The relative success rates and pain scores for each procedure. The validity of saline infusion hysterosonography as a diagnostic test. RESULTS: One hundred and seventeen women entered the study; 70 women were premenopausal and 47 postmenopausal. In 27 women, one or both procedures could not be performed. Saline infusion hysterosonography failed in 20 women, on one occasion hysteroscopy failed and both investigations failed in six women. Ninety cases remained for direct comparison, with 78 cases of agreement on the uterine findings in both investigations. Twelve cases disagreed; in one case, an adhesion was seen, two cases with polyps and five with fibroids seen on ultrasound but not seen on hysteroscopy. There were four cases where polyps were identified on hysteroscopy but not on saline infusion hysterosonography. The median pain scores were 1.6 for saline infusion hysterosonography and 3.2 for hysteroscopy. CONCLUSIONS: Both saline infusion hysterosonography and hysteroscopy are well tolerated by women. Saline infusion hysterosonography has a high failure rate but has a lower pain score than hysteroscopy.