Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence.

BACKGROUND: Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. METHODS: We performed a double-blind, double-placebo-controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. RESULTS: Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P=0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P=0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P=0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P=0.01) and urinary tract infections (13% vs. 33%, P<0.001). CONCLUSIONS: Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; ClinicalTrials.gov number, NCT01166438.).

Long-term outcomes after native tissue vs. biological graft-augmented repair in the posterior compartment.

INTRODUCTION AND HYPOTHESIS: We aimed to compare the outcomes of native tissue vs. biological graft-augmented repair in the posterior compartment. We hypothesized that the addition of graft would result in superior anatomic and functional outcomes. METHODS: A retrospective review of posterior repairs between 2001 and 2008 was performed to compare the anatomic and functional outcomes between native tissue and graft-augmented techniques. Mann-Whitney and chi-square tests were used. Power calculation determined that 32 subjects were needed in each group. RESULTS: One hundred twenty-four native tissue and 69 graft-augmented repairs were performed with a median follow-up of 35.8 months (range, 6 to 157 months). Anatomic success was similar for native tissue vs. graft (Bp < -1, 86% vs. 80% and Bp ≤ 0, 97% vs. 97%; all p > 0.05). Postoperative splinting and incomplete evacuation was greater in the graft group (splinting, 85% vs. 68%; p = 0.04 and incomplete evacuation, 85% vs. 64%; p = 0.03). CONCLUSION: Long-term success of posterior repair is high. Graft augmentation does not appear to improve anatomic or functional outcomes.

Adverse events associated with pelvic organ prolapse surgeries that use implants.

OBJECTIVE: To estimate the rate of vaginal implant exposure associated with biologic grafts and permanent mesh used for pelvic organ prolapse (POP) surgery, to describe treatments used for these complications, and to estimate response rates to these treatments. The secondary aims were to describe the operative and perioperative complications. METHODS: This was a retrospective analysis of female members of Kaiser Permanente Southern and Northern California and Hawaii who underwent POP surgeries with biologic grafts and permanent mesh between September 2008 and May 2010. Inpatient and outpatient electronic medical records were reviewed for postoperative adverse events. RESULTS: During the 21-month period, 1,282 women, mean age of 62 years (±10 standard deviation), median parity of 3 (interquartile range 2-4), and median body mass index of 28 (interquartile range 24-30) underwent prolapse repairs with 1,484 implants with a mean follow-up time of 358 days (±276 standard deviation). Vaginal exposures occurred more often with permanent mesh (53/847 [6%]) than biologic grafts (10/637 [1.6%]) (P<.001). Resolution of vaginal exposure after the first treatment occurred in 24 of 63 (38%), whereas 39 of 63 (62%) required multiple treatments. Surgical excision was performed in 20 of 63 (32%) exposures. Permanent mesh exposures were more likely to require surgical excision (20/53 [38%]) than biologic graft exposures (zero of 10) (P=.02). CONCLUSION: Vaginal exposure occurred more frequently with permanent mesh than biologic graft, may require multiple treatments, and occasionally require surgical excision. LEVEL OF EVIDENCE: : II.

Anticholinergic versus botulinum toxin A comparison trial for the treatment of bothersome urge urinary incontinence: ABC trial.

This trial compares the change in urgency urinary incontinence episodes over 6 months, tolerability and cost effectiveness between women receiving daily anticholinergic therapy plus a single intra-detrusor injection of saline versus a single intra-detrusor injection of 100 U of botulinum toxin A plus daily oral placebo tablets. We present the rationale and design of a randomized-controlled trial, Anticholinergic versus Botulinum Toxin, Comparison Trial for the Treatment of Bothersome Urge Urinary Incontinence: ABC trial, conducted by the NICHD-funded Pelvic Floor Disorders Network. We discuss the innovative nature of this trial and the challenges related to choice of patient population, maintaining masking, cost effectiveness, ethical considerations, measuring adherence, and placebo development and testing. Enrollment began in April, 2010. 242 participants will be randomized and primary outcome data analysis is anticipated to begin in mid 2012. Several challenges in the trial design are discussed. Randomization to placebo intra-detrusor injections may limit recruitment, potentially impacting generalizability. Other challenges included the heavy marketing of drugs for overactive bladder which could impact recruitment of drug-naïve women. In addition, anticholinergic medications often cause dry mouth, making masking difficult. Finally, adverse reporting of transient urinary retention is challenging as there is no standardized definition; yet this is the most common adverse event following intra-detrusor botulinum toxin injection. The ABC trial will help women with urgency urinary incontinence balance efficacy, side effects and cost of anticholinergic medication versus botulinum toxin intra-detrusor injection. The results have the potential to fundamentally change the therapeutic approach to this condition.