Management of mid-urethral tape complications: a retrospective study.

BACKGROUND/PURPOSE OF THE STUDY: Following mid-urethral tape insertion, for stress urinary incontinence (SUI), a proportion of women experience complications such as voiding dysfunction or tape erosion which fail to respond to conservative management approaches. These women thus require further surgical treatment. Our objective was to describe the outcomes of the surgical management of complications in these women. METHODS: This retrospective study describes the results obtained following the surgical management of mid-urethral tape complications. Twenty-nine consecutive women who required mid-urethral tape lysis, loosening or excision for tape-related complications in the period 2007-2017 were included. Primary outcomes were improvement in voiding dysfunction and resolution of pain, while secondary outcomes were evaluation of the recurrence of stress urinary incontinence and patient satisfaction. Patient outcomes were measured using the Patient Global Impression of Improvement questionnaire. RESULTS: There were 1459 mid-urethral tape procedures performed in the study period. Twenty-nine women (1.99%) who had revision surgery for tape complication were identified. Interventions included tape loosening or lysis in 19 women and tape excision in ten women. Twenty-three of the 29 patients reported a significant improvement in their symptoms postoperatively. Two women had a recurrence of SUI in the tape excision cohort; all patients following tape loosening or lysis remained continent. CONCLUSIONS: Tape revision surgery is a safe and effective treatment for mid-urethral tape complications with the majority of women maintaining continence following revision. Early intervention and proactive management of complications, by the appropriate specialist, will improve outcomes.

Management of complications arising from the use of mesh for stress urinary incontinence-International Urogynecology Association Research and Development Committee opinion.

INTRODUCTION AND HYPOTHESIS: Management of pain or mesh exposure complications after stress incontinence surgery has become a new issue over the last 20 years with the introduction of mesh techniques to treat stress incontinence. There is much debate regarding the incidence of complications and how best to treat them. METHODS: A working subcommittee from the International Urogynecology Association (IUGA) Research and Development (R&D) Committee was formed. An initial document was drafted based on a literature review. The review focused on complications of vaginal mesh inserted for stress incontinence. After evaluation by the entire IUGA R&D Committee revisions were made. The final document represents the IUGA R&D Committee Opinion. RESULTS: The R&D Committee Opinion reviews the literature on the management of complications arising from the use of mesh for stress urinary incontinence. The review concentrated on the assessment and treatment of pain and exposure. CONCLUSIONS: Complications after surgery for stress incontinence using mesh may not be common occurrences for individual surgeons. Complications may be difficult to manage and outcomes are variable. Specialist centres and a multidisciplinary approach may optimise treatment and reporting of outcomes.

Interventions to reduce morbidity from vault hematoma following vaginal hysterectomy: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: A frequent complication following vaginal hysterectomy is the formation of vaginal vault hematoma. The objective of our systematic review was to assess the impact of various interventions in reducing the incidence of vault hematoma or postoperative febrile morbidity following vaginal hysterectomy. METHODS: We carried out a systematic search of Cochrane, MEDLINE, Embase, CINAHL, HTA database, PROSPERO, meta-Register of Controlled Trials (mRCT), PubMed, CENTRAL, Google Scholar, conference abstracts, and a hand search of journals from inception until September 2018. Our search strategy included interventions in women undergoing vaginal hysterectomy with modified vault closure with inclusion of peritoneal edges, vaginal vault drainage, or vaginal packing to reduce the incidence of clinically significant vault hematomas. Two independent reviewers (SR and AD) extracted data using a structured proforma. Meta-analysis was carried out using RevMan 5.3 software. RESULTS: We identified two studies on modified vaginal vault closure incorporating peritoneal edges that reported a significant reduction in vault hematoma incidence. Meta-analysis of two randomized trials on vaginal drains showed no difference in postoperative febrile morbidity secondary to vault hematoma [risk ratio (RR) 0.8, 95% confidence intervals (CI) 0.43-1.50]. Similar results were seen on meta-analysis of four randomized trials on the use of vaginal packing (RR 0.8, 95% CI 0.43-1.50). CONCLUSIONS: Inclusion of peritoneal edges in vaginal vault closure may reduce the incidence of vault hematoma. The routine use of vaginal vault drainage and/or packing has not shown to reduce vault hematoma incidence or postoperative febrile morbidity. We recommend a change of practice to include peritoneal edges in vault closure based on the evidence available in our systematic review.

Reproducibility of the transvaginal sonographic assessment of bladder wall thickness.

OBJECTIVE: To assess whether transvaginal sonographic measurements of bladder wall thickness (BWT) have adequate reproducibility to detect differences in BWT potentially indicative of detrusor overactivity in women with overactive bladder. STUDY DESIGN: Three reproducibility studies were undertaken to assess (A) total measurement error, (B) intra-observer variability and (C) inter-observer measurement in the interpretation of scans. Women recruited to the Bladder Ultrasound Study underwent a transvaginal ultrasound scan to obtain a measurement of BWT. When a second observer was available, women who agreed to have two transvaginal scans by different operators were recruited into study A. For study B the first observer reassessed a sample of the recorded images at a later date whilst for study C, a random selection of BWT images were read by a second assessor. Analytical variability, percentage of variability attributable to measurement error, within-person variation and the smallest real difference detectable were estimated. RESULTS: One hundred and twenty-one women took part: 27 had repeat scans, 37 had scans re-read by the same observer, and 57 had scans read by two observers. In study A, 39% of the total variability in measurements was explained by measurement error (the remainder to within person change); the standard deviation (SD) of measurement error was 0.76mm and the smallest detectable clinical difference was 2.1mm. The SD of measurement error from scan interpretation was 0.42mm within observers (study B) and 0.35mm between observers (studyC). CONCLUSION: The high levels of measurement error for a small measurement of BWT means it is unlikely Transvaginal ultrasound measurements have insufficient reliability and reproducibility to be an accurate diagnostic test.

Digital rectal examination in the evaluation of rectovaginal septal defects.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the diagnostic potential of digital rectal examination in the identification of a true rectocele. METHODS: This is a retrospective observational study utilising 187 archived data sets of women presenting with lower urinary tract symptoms and/or pelvic organ prolapse between August 2012 and November 2013. Evaluation included a standardised interview, ICS-POPQ, rectal examination and 4D translabial ultrasound. The main outcome measure was the diagnosis of rectocele by digital rectal palpation on Valsalva manoeuvre. This diagnosis correlated with the sonographic diagnosis of rectocele to determine agreement between digital examination and ultrasound findings. RESULTS: Complete data sets were available for 180 participants. On imaging, the mean position of the rectal ampulla was 11.07 (-36.3 to 44.3) mm below the symphysis pubis; 42.8% (77) had a rectocele of a depth of ≥10 mm. On palpation, a rectocele was detected in 60 women (33%). Agreement between palpation and imaging was observed in 77%; the kappa was 0.52 (CI 0.39-0.65). On receiver operator characteristic analysis, the area under the curve was 0.854 for the relationship between rectocele pocket depth and the detection of rectocele on palpation. CONCLUSION: Moderate agreement was found between digital rectal examination for rectocele and translabial ultrasound findings of a "true rectocele". Digital rectal examination may be used to identify these defects in clinical practice. Extending the clinical examination of prolapse to include rectal examination to palpate defects in the rectovaginal septum may reduce the need for defecatory proctograms for the assessment of obstructive defecation and may help triage patients in the management of posterior compartment prolapse.

Effectiveness of BTX-A and neuromodulation in treating OAB with or without detrusor overactivity: a systematic review.

INTRODUCTION AND HYPOTHESIS: Patients with refractory overactive bladder (OAB) pose a therapeutic challenge. Guidelines such as those from the National Institute for Health and Care Excellence recommend invasive treatments such as botulinum toxin-A ((BTX-A), sacral neural stimulation (SNS) etc. only if there is detrusor overactivity (DO) on urodynamics. METHODS: Our aim was to systematically evaluate evidence based on the presence or absence of DO in relation to differences in effectiveness and complications related to invasive treatment in patients with refractory OAB. We carried out a systematic search of Cochrane, MEDLINE, Embase, CINAHL, LILACS, meta-Register of Controlled Trials (mRCT), CENTRAL, and Google Scholar databases from inception until April 2016. Abstracts presented at IUGA, ICS and EAU conferences (until April 2016) were included and journals that were hand searched. RESULTS: We found five studies (two prospective cohort studies and subgroup analyses of two randomized controlled trials (RCTs) and one cohort study for BTX-A, one multicenter prospective cohort study for percutaneous tibial nerve stimulation (PTNS) and three (one RCT and two cohort studies) for SNS. The outcomes in patients without (n = 77) or with (n = 135) DO were similar in the context of urodynamic findings, bladder diaries, quality of life (QoL) questionnaires, etc. when treated with BTX-A [odds ratio (OR) 1.52, 95% confidence interval (CI) 0.40-5.77] or SNS (50 patients without and 81 with DO; OR1.37, CI 0.76-2.48). Outcomes for PTNS (based on a single study) seem to be better in patients without DO. CONCLUSION: The limited evidence suggests that urodynamic diagnosis of DO does not alter patient reported outcomes for invasive treatments such as BTX-A and SNS. Noninferiority RCTs powered to evaluate the role of DO in predicting treatment response are required.

Testing and Treating Women after Unsuccessful Conservative Treatments for Overactive Bladder or Mixed Urinary Incontinence: A Model-Based Economic Evaluation Based on the BUS Study.

OBJECTIVE: To compare the cost-effectiveness of bladder ultrasonography, clinical history, and urodynamic testing in guiding treatment decisions in a secondary care setting for women failing first line conservative treatment for overactive bladder or urgency-predominant mixed urinary incontinence. DESIGN: Model-based economic evaluation from a UK National Health Service (NHS) perspective using data from the Bladder Ultrasound Study (BUS) and secondary sources. METHODS: Cost-effectiveness analysis using a decision tree and a 5-year time horizon based on the outcomes of cost per woman successfully treated and cost per Quality-Adjusted Life-Year (QALY). Deterministic and probabilistic sensitivity analyses, and a value of information analysis are also undertaken. RESULTS: Bladder ultrasonography is more costly and less effective test-treat strategy than clinical history and urodynamics. Treatment on the basis of clinical history alone has an incremental cost-effectiveness ratio (ICER) of £491,100 per woman successfully treated and an ICER of £60,200 per QALY compared with the treatment of all women on the basis of urodynamics. Restricting the use of urodynamics to women with a clinical history of mixed urinary incontinence only is the optimal test-treat strategy on cost-effectiveness grounds with ICERs of £19,500 per woman successfully treated and £12,700 per QALY compared with the treatment of all women based upon urodynamics. Conclusions remained robust to sensitivity analyses, but subject to large uncertainties. CONCLUSIONS: Treatment based upon urodynamics can be seen as a cost-effective strategy, and particularly when targeted at women with clinical history of mixed urinary incontinence only. Further research is needed to resolve current decision uncertainty.

Bladder ultrasonography for diagnosing detrusor overactivity: test accuracy study and economic evaluation.

BACKGROUND: Urodynamics (UDS) has been considered the gold standard test for detrusor overactivity (DO) in women with an overactive bladder (OAB). Bladder ultrasonography to measure bladder wall thickness (BWT) is less invasive and has been proposed as an alternative test. OBJECTIVES: To estimate the reliability, reproducibility, accuracy and acceptability of BWT in women with OAB, measured by ultrasonography, in the diagnosis of DO; to explore the role of UDS and its impact on treatment outcomes; and to conduct an economic evaluation of alternative care pathways. DESIGN: A cross-sectional test accuracy study. SETTING: 22 UK hospitals. PARTICIPANTS: 687 women with OAB. METHODS: BWT was measured using transvaginal ultrasonography, and DO was assessed using UDS, which was performed blind to ultrasonographic findings. Intraobserver and interobserver reproducibility were assessed by repeated measurements from scans in 37 and 57 women, respectively, and by repeated scans in 27 women. Sensitivity and specificity were computed at pre-specified thresholds. The smallest real differences detectable of BWT were estimated using one-way analysis of variance. The pain and acceptability of both tests were evaluated by a questionnaire. Patient symptoms were measured before testing and after 6 and 12 months using the International Consultation on Incontinence modular Questionnaire Overactive Bladder (short form) (ICIQ-OAB) questionnaire and a global impression of improvement elicited at 12 months. Interventions and patient outcomes were analysed according to urodynamic diagnoses and BWT measurements. A decision-analytic model compared the cost-effectiveness of care strategies using UDS, ultrasonography or clinical history, estimating the cost per woman successfully treated and the cost per quality-adjusted life-year (QALY). RESULTS: BWT showed very low sensitivity and specificity at all pre-specified cut-off points, and there was no evidence of discrimination at any threshold (p = 0.25). Extensive sensitivity and subgroup analyses did not alter the interpretation of these findings. The smallest detectable difference in BWT was estimated to be 2 mm. Pain levels following both tests appeared relatively low. The proportion of women who found the test 'totally acceptable' was significantly higher with ultrasonography than UDS (81% vs. 56%; p < 0.001). Overall, subsequent treatment was highly associated with urodynamic diagnosis (p < 0.0001). There was no evidence that BWT had any relationship with the global impression of improvement responses at 20 months (p = 0.4). Bladder ultrasonography was more costly and less effective than the other strategies. The incremental cost-effectiveness ratio (ICER) of basing treatment on the primary clinical presentation compared with UDS was £491,500 per woman successfully treated and £60,200 per QALY. Performing a UDS in those women with a clinical history of mixed urinary incontinence had an ICER of £19,500 per woman successfully treated and £12,700 per QALY compared with the provision of urodynamic to all women. For DO cases detected, UDS was the most cost-effective strategy. CONCLUSION: There was no evidence that BWT had any relationship with DO, regardless of the cut-off point, nor any relationship to symptoms as measured by the ICIQ-OAB. Bladder ultrasonography has no diagnostic or prognostic value as a test in this condition. Furthermore, despite its greater acceptability, BWT measurement was not sufficiently reliable or reproducible. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46820623. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 7. See the NIHR Journals Library website for further project information.

Urodynamics Before Surgery for Stress Urinary Incontinence.

Following three noninferiority randomised controlled trials from different countries showing exactly the same results, it is time to translate this evidence into practice. In women undergoing primary surgery for pure stress urinary incontinence or stress-predominant mixed urinary incontinence without voiding difficulties, careful office evaluation including uroflowmetry and postvoid residual urine can replace invasive investigations such as cystometry, saving patients from embarrassment and a risk of urinary infection.