What if there were no tapes?

It is possible that the controversy involving prostheses implanted into women with pelvic floor problems might result in the majority of, or even all such products being restricted, banned or withdrawn in certain jurisdictions. A clear distinction between "tapes" for urinary incontinence and "mesh" for prolapse has been made in the enquiries and subsequent rulings in Australia and New Zealand. Transvaginal "mesh" will be unavailable with the range of "tapes" much more restricted in those countries from January 2018. The Chair of the all-party parliamentary group on surgical mesh implants in the United Kingdom was reported as describing the New Zealand announcement as "hugely significant" and "it's precisely what we've been calling for the UK." The title of this article has changed from a hypothetical piece to a potential reality review. Where does that leave the clinicians treating stress urinary incontinence (SUI) and the large number of female sufferers? "Tapes" (synthetic midurethral slings-MUS) have become very popular over the last 20 years since their original development and introduction in Scandanavia. Evidence-based medicine has shown their advantages over previous surgeries, in terms of ease of use, safety and efficacy. This article outlines the options which countries potentially rejecting the use of tapes, must now resort to for women with SUI. Those countries considering such action need the note of caution that none of the options are as good as tapes.

Randomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 month results.

OBJECTIVE: The objective of the study was to evaluate objective and subjective outcomes of MiniArc and Monarc (American Medical Systems, Minnetonka, MN) midurethral sling (MUS) in women with stress incontinence at 12 months. STUDY DESIGN: A total of 225 women were randomized to receive MiniArc or Monarc. Women with intrinsic sphincter deficiency, previous MUS, or untreated detrusor overactivity were excluded. Objective cure was defined as negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with coughing or exercise on questionnaire. Validated questionnaires, together with urodynamic and clinical cough stress test, were used to evaluate the objective and subjective outcomes following surgery. Participants and clinicians were not masked to treatment allocation. Outcomes were compared with exact binomial tests (eg, Fisher exact test for dichotomous data) for categorical data and Student t tests or exact versions of Wilcoxon tests for numerical data as appropriate. RESULTS: There was no statistically significant difference in the subjective (92.2% vs 94.2%; P = .78; difference, 2.0%; 95% confidence interval, -2.7% to +6.7%) or objective (94.4% vs 96.7%; P = .50; difference, 2.3%; 95% confidence interval, -1.5% to +6.1%) cure rates between MiniArc and Monarc at 12 m, respectively, with a significant improvement in overactive bladder outcomes and incontinence impact from baseline in both arms. CONCLUSION: MiniArc outcomes are not inferior to Monarc MUS outcomes at 12 months' follow-up in women without intrinsic sphincter deficiency.

Which women develop urgency or urgency urinary incontinence following midurethral slings?

INTRODUCTION AND HYPOTHESIS: De novo urgency has a negative impact on women after midurethral sling (MUS). We aimed to identify risk factors for de novo urgency (dU) and urgency urinary incontinence (dUUI) following MUS, using multivariate analysis. METHODS: We investigated 358 consecutive women with only stress urinary incontinence (SUI) [or urodynamic stress incontinence (USI)] and 598 women with both SUI (or USI) and urgency (but not UUI) who underwent MUS with a mean follow-up of 50 months. Women who developed dU or dUUI at long-term follow-up were compared to those who did not. RESULTS: dU occurred in 27.7 % (99/358) and dUUI occurred in 13.7 % (82/598) of women at long-term follow-up after midurethral sling. Intrinsic sphincter deficiency {odds ratio (OR) dU 3.94 [95 % confidence interval (CI) 1.50-10.38]; OR dUUI 2.5 (1.31-4.80)}, previous stress incontinence surgery [sling: OR dU 3.69 (1.45-9.37); colposuspension: OR dUUI 2.5 (1.23-5.07)], previous prolapse surgery [OR dU 2.45 (1.18-5.10)], preexisting detrusor overactivity [OR dU 1.99 (1.15-3.48); OR dUUI 1.85 (1.31-2.60)] increased the risk, whereas performing concomitant apical prolapse surgery [OR dU 0.5 (0.41-0.81); OR dUUI 0.29 (0.087-0.97)] significantly decreased the risk. Women are more likely to not recommend surgery when they experienced dU (18.2 vs 0.8 %, p < 0.0001) or dUUI (20.7 vs 2.1 %, p < 0.0001). CONCLUSIONS: Urodynamic parameters, history of prior incontinence or prolapse surgery and concomitant apical prolapse operation were important predictors of dU or dUUI following MUS.

Mesh-related chronic infections in silicone-coated polyester suburethral slings.

INTRODUCTION AND HYPOTHESIS: despite claims of equivalence to the tension-free vaginal tape, a variety of suburethral slings have been introduced, with various modifications. Complications in certain synthetic slings and meshes have led to a recent FDA public health notification. METHODS: we report the case histories and management of five women with complications following implant of an InFast sling. RESULTS: four of the five patients presented with symptom of chronic vaginal discharge, one presenting with irritative voiding symptoms and bladder pain. Resolution of presenting symptoms requires total removal of this silicone-coated polyester mesh, which often requires a combined vaginal-abdominal approach. CONCLUSIONS: the silicone-coated mesh of the AMS InFAST sling, can become a focus for chronic infection forming a sinus tract into the vagina or other viscus, causing symptoms years after its placement.

TVT Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence - A randomised controlled trial.

INTRODUCTION: Single incision slings (SIS) were introduced in an attempt to decrease the complications associated with retropubic and transobturator slings. The TVT Abbrevo is a modification of the TVT-O with a reduced length and less immediate postoperative pain. The Miniarc SIS has been shown to be equivalent to outside-in transobturator sling, Monarc at 12 month follow-up. OBJECTIVE: To evaluate objective and subjective outcomes of MiniArc SIS and TVT Abbrevo midurethral sling (MUS) in women with stress urinary incontinence. METHODS: Female subjects who were assessed and referred for stress urinary incontinence surgery were eligible to participate in this study. Exclusion criteria included women with intrinsic sphincter deficiency previous failed midurethral or fascial sling, untreated detrusor overactivity or significant voiding dysfunction. Patients' randomisation was performed with computer-generated blocks of 4-8, with concealed allocation. Assuming an objective cure rate of 90% for TVT AbbrevoTMwith a power of 80%, a sample size of 79 in each arm was required to detect a clinical difference of 15%, using a one sided alpha of 0.05. The target recruitment number was 220 allowing for an attrition rate of 15%. Institution ethics approval (11261B) was obtained and the trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611001151921). Routine preoperative assessment was conducted for objective data, whilst patient reported outcome tools (PRO) were utilised for subjective outcomes. These include ICIQ UI SF, ICIQ OAB, IIQ7, EQ5D, PISQ12, PGIs & PGII. TVT AbbrevoTM or MiniarcTMwere performed in a standardized fashion, together with any concomitant prolapse surgery. Review was conducted at 6 weeks and at 6 and 12 months. Objective cure was defined as a negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with physical exertion. All Data was collected and outcomes were analysed statistically. RESULTS: Between February 2011 and January 2016,a total of 246 women were randomized to receive MiniArc (121) or TVT Abbrevo (125). Baseline characteristics were clinically balanced in both groups. At 6 months subjective (94.4% vs 95.7% p=0.74) and Objective (92.9% vs 95.9% p=0.49) cure rates were high and not statistically different. At 12 months there were also no differences in subjective (73.6% vs 76.9% p=0.73) or objective (90.5% vs 96.0% p=0.21) cure rates. No differences were found in functional outcomes or when adjusted for potential confounding factors such as age, parity, BMI or menopausal status. CONCLUSION: We found no significant differences in subjective and objective cure rates at 6 and 12months between MiniArc and TVT Abbrevo.

Ruptured tubal ectopic pregnancy with negative serum beta hCG--a case for ongoing vigilance?

A 25-year-old female with a history of recent miscarriage presents with haemodynamic shock and a negative serum beta hCG. She presents to six different healthcare facilities within a single metropolitan area, during which a pelvic ultrasound scan showed an empty uterus with a subnormal rise in serum beta hCG. Suspected ruptured tubal ectopic pregnancy was confirmed following laparoscopy and salpingectomy, with histopathological confirmation of chorionic villi in the extirpated fallopian tube. This case report highlights the ongoing clinical diagnostic challenges that are associated with ectopic pregnancy; illustrates the importance of teamwork; and perhaps also draws attention to the need for a robust protocol to facilitate consistent, good-quality early pregnancy care for all women.