PURPOSE: This clinical trial evaluated the efficacy, safety, and tolerability of a novel pressure-attenuation device for the reduction or elimination of female stress urinary incontinence (SUI) using a prospective, randomized, single-blind, multi-center design.
MATERIALS AND METHODS: 166 females with SUI were randomized 2:1 to treatment with an intravesical pressure-attenuation device (N=112) or sham procedure (N=54). In the treatment arm, the device was replaced every 90 days; in the sham arm, device replacement was simulated every 90 days. The primary outcome measure was Stamey Score improvement of = 1 at 6 months. An additional outcome measure evaluated at 6 months was a composite score combining data from a provocative pad test and patient impression of symptom improvement.
RESULTS: In the treatment arm, 40.9% of women achieved the primary endpoint, compared to only 22.4% in the sham arm (P=.046 in per-protocol analysis). In an Intent-To-Treat (ITT) analysis, 28.6% of women in the treatment arm reached the primary endpoint vs. 22.2% of women in the sham arm (P=.455). 50.8% of women in the treatment arm reached the composite endpoint compared to 16.3% of women in the control arm (P < 0.001, ITT analysis). Three-day voiding diaries revealed a mean reduction in total daily leakage events after 6 months from 4.4/day to 2.5/day (43.2%) in the treatment group versus 5.4/day to 4.1/day (24.1% reduction) in the control group (P < .001).
CONCLUSIONS: Minimally invasive treatment for female SUI with a first-generation intravesical pressure-attenuation device was safe and effective when evaluated by a composite endpoint. For those patients that can tolerate the device., the concept of pressure attenuation as a therapy for SUI is valid and feasible. Further modifications are anticipated for this device potentially resulting in improved outcomes.
Written by:
Rovner ES, Dmochowski RR, Leach GE, Jayne C, Snyder JA. Are you the author?
Department of Urology, Medical University of South Carolina, Charleston SC, USA.
Reference: J Urol. 2013 Jun 21. pii: S0022-5347(13)04659-4.
doi: 10.1016/j.juro.2013.06.042
PubMed Abstract
PMID: 23796570
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