Jean-Jacques Wyndaele1, Stefan De Wachter2, Giovanni A Tommaselli3, Roberto Angioli4, Michel J de Wildt5, Karel C M Everaert6, Dirk P J Michielsen7, Gommert A Van Koeveringe8. 1. Faculty of Medicine, University of Antwerp-Urology, Antwerp, Belgium. 2. University of Antwerp-Urology, Antwerp, Belgium. 3. Universita Degli Studi Di Napoli "Federico II,", Naples, Italy. 4. Universita di Roma Campus Biomedico, Rome, Italy. 5. Catharina Ziekenhuis, Eindhoven, The Netherlands. 6. Ghent University Hospital, Gent, Belgium. 7. UZBrussel-Urology, Brussels, Belgium. 8. Maastricht University Medical Centre, Department of Urology, Maastricht, The Netherlands.
Abstract
AIMS: Evaluate the efficacy, safety, and tolerability of a novel pressure-attenuation balloon for the treatment of female stress urinary incontinence (SUI) using a prospective, randomized, single-blind, multi-center design, evaluated at 3 months. METHODS:Sixty-three females with SUI were randomized 2:1 to treatment with a balloon (N = 41) or sham procedure (N = 22). The sham (control) entailed the same procedure without the deployment of a balloon. Endpoints were evaluated at 3 months and included a composite endpoint that required both ≥10 point increase in the 22-item Incontinence Quality of Life Survey (I-QOL) and ≥50% decrease in provocative pad weight. Additional endpoints included incontinence episode frequency, and PGII assessment. RESULTS: In an ITT analysis, 63% of women in the treatment group achieved the composite endpoint, compared to 31% in the Control Group (P = 0.0200). In a per protocol analysis, 81% of women in the treatment arm had a 50% decrease in pad weight test vs. 45% in the Control Group (P = 0.0143); 41.6% of the treatment patients were dry on pad weight test (≤1gram) vs. 0% in the Control Group (P < 0.001), and 58% of treated patients reported improvement on a PGII assessment versus 25% of women in the Control Group (P = 0.025). Adverse events in the treatment group included dysuria (14.6%), gross hematuria (9.8%), and UTI (7.3%). CONCLUSIONS: This minimally invasive treatment for female SUI with an intravesical pressure-attenuation balloon was safe and effective. The concept of pressure attenuation as a therapy for SUI is valid and feasible for those patients that can tolerate the balloon.
RCT Entities:
AIMS: Evaluate the efficacy, safety, and tolerability of a novel pressure-attenuation balloon for the treatment of female stress urinary incontinence (SUI) using a prospective, randomized, single-blind, multi-center design, evaluated at 3 months. METHODS: Sixty-three females with SUI were randomized 2:1 to treatment with a balloon (N = 41) or sham procedure (N = 22). The sham (control) entailed the same procedure without the deployment of a balloon. Endpoints were evaluated at 3 months and included a composite endpoint that required both ≥10 point increase in the 22-item Incontinence Quality of Life Survey (I-QOL) and ≥50% decrease in provocative pad weight. Additional endpoints included incontinence episode frequency, and PGII assessment. RESULTS: In an ITT analysis, 63% of women in the treatment group achieved the composite endpoint, compared to 31% in the Control Group (P = 0.0200). In a per protocol analysis, 81% of women in the treatment arm had a 50% decrease in pad weight test vs. 45% in the Control Group (P = 0.0143); 41.6% of the treatment patients were dry on pad weight test (≤1gram) vs. 0% in the Control Group (P < 0.001), and 58% of treated patients reported improvement on a PGII assessment versus 25% of women in the Control Group (P = 0.025). Adverse events in the treatment group included dysuria (14.6%), gross hematuria (9.8%), and UTI (7.3%). CONCLUSIONS: This minimally invasive treatment for female SUI with an intravesical pressure-attenuation balloon was safe and effective. The concept of pressure attenuation as a therapy for SUI is valid and feasible for those patients that can tolerate the balloon.
Authors: Ron J Jankowski; Le Mai Tu; Christopher Carlson; Magali Robert; Kevin Carlson; David Quinlan; Andreas Eisenhardt; Min Chen; Scott Snyder; Ryan Pruchnic; Michael Chancellor; Roger Dmochowski; Melissa R Kaufman; Lesley Carr Journal: Int Urol Nephrol Date: 2018-10-15 Impact factor: 2.370
Authors: Gommert A van Koeveringe; Stefan De Wachter; Jack M Zuckerman; Giovanni Tommaselli; Michel J de Wildt; Karel C M Everaert; Dirk P J Michielsen; Jean-Jacques Wyndaele Journal: Adv Ther Date: 2017-06-09 Impact factor: 3.845
Authors: Harvey Winkler; Karny Jacoby; Susan Kalota; Jeffrey Snyder; Kevin Cline; Kaiser Robertson; Randall Kahan; Lonny Green; Kurt McCammon; Eric Rovner; Charles Rardin Journal: Female Pelvic Med Reconstr Surg Date: 2018 May/Jun Impact factor: 2.091