A randomized, controlled clinical trial of a novel intravesical pressure attenuation device for the treatment of stress urinary incontinence.

ABSTRACT

PURPOSE: In this clinical trial we evaluated the efficacy, safety and tolerability of a novel pressure attenuation device for the reduction or elimination of female stress urinary incontinence using a prospective, randomized, single-blind, multicenter design. MATERIALS AND METHODS: A total of 166 female patients with stress urinary incontinence were randomized 21 to treatment with an intravesical pressure attenuation device (112) or sham procedure (54). In the treatment arm the device was replaced every 90 days and in the sham arm device replacement was simulated every 90 days. The primary outcome measure was Stamey score improvement of 1 or more 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 end point, compared to only 22.4% in the sham arm (p=0.046 in per protocol analysis). In an intent to treat analysis, 28.6% of women in the treatment arm reached the primary end point vs 22.2% of women in the sham arm (p=0.455). 50.8% of women in the treatment arm reached the composite end point compared to 16.3% of women in the control arm (p<0.001, intent to treat analysis). Three-day voiding diaries revealed a mean reduction in total daily leakage events after 6 months from 4.4 per day to 2.5 per day (43.2%) in the treatment group vs 5.4 per day to 4.1 per day (24.1% reduction) in the control group (p<0.001). CONCLUSIONS: Minimally invasive treatment for female stress urinary incontinence with a first-generation intravesical pressure attenuation device was safe and effective when evaluated by a composite end point. For those patients that can tolerate the device, the concept of pressure attenuation as a therapy for stress urinary incontinence is valid and feasible. Further modifications are anticipated for this device potentially resulting in improved outcomes.