title: A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females.
abstract: OBJECTIVE
  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.affiliation: Faculty of Medicine, University of Antwerp-Urology, Antwerp, Belgium.
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Wyndaele
authors.affiliation: University of Antwerp-Urology, Antwerp, Belgium.
authors.forename: Stefan
authors.initials: S
authors.lastname: De Wachter
authors.affiliation: Universita Degli Studi Di Napoli "Federico II,", Naples, Italy.
authors.forename: Giovanni A
authors.initials: GA
authors.lastname: Tommaselli
authors.affiliation: Universita di Roma Campus Biomedico, Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Angioli
authors.affiliation: Catharina Ziekenhuis, Eindhoven, The Netherlands.
authors.forename: Michel J
authors.initials: MJ
authors.lastname: de Wildt
authors.affiliation: Ghent University Hospital, Gent, Belgium.
authors.forename: Karel C M
authors.initials: KC
authors.lastname: Everaert
authors.affiliation: UZBrussel-Urology, Brussels, Belgium.
authors.forename: Dirk P J
authors.initials: DP
authors.lastname: Michielsen
authors.affiliation: Maastricht University Medical Centre, Department of Urology, Maastricht, The Netherlands.
authors.forename: Gommert A
authors.initials: GA
authors.lastname: Van Koeveringe
mesh_terms: D002408:Catheters, Indwelling; D003558:Cystoscopy; D004867:Equipment Design; D005060:Europe; D005260:Female; D006801:Humans; D016496:Incontinence Pads; D008875:Middle Aged; D011312:Pressure; D011446:Prospective Studies; D011788:Quality of Life; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000503:physiopathology*; D014546:Urinary Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D014550:Urinary Incontinence, Stress / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D014563:Urodynamics
keywords: balloon; bladder control; intravesical; pressure-attenuation; stress urinary incontinence; urinary incontinence