Advanced search
1 file | 1.15 MB Add to list

A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females

(2016) NEUROUROLOGY AND URODYNAMICS. 35(2). p.252-259
Author
Organization
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.
Keywords
bladder control, balloon, intravesical, pressure-attenuation, stress urinary incontinence, urinary incontinence

Downloads

  • nau22708.pdf
    • full text
    • |
    • open access
    • |
    • PDF
    • |
    • 1.15 MB

Citation

Please use this url to cite or link to this publication:

MLA
Wyndaele, Jean-Jacques et al. “A Randomized, Controlled Clinical Trial of an Intravesical Pressure-attenuation Balloon System for the Treatment of Stress Urinary Incontinence in Females.” NEUROUROLOGY AND URODYNAMICS 35.2 (2016): 252–259. Print.
APA
Wyndaele, J.-J., De Wachter, S., Tommaselli, G. A., Angioli, R., de Wildt, M. J., Everaert, K., Michielsen, D. P., et al. (2016). A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females. NEUROUROLOGY AND URODYNAMICS, 35(2), 252–259.
Chicago author-date
Wyndaele, Jean-Jacques, Stefan De Wachter, Giovanni A Tommaselli, Roberto Angioli, Michel J de Wildt, Karel Everaert, Dirk PJ Michielsen, and Gommert A Van Koeveringe. 2016. “A Randomized, Controlled Clinical Trial of an Intravesical Pressure-attenuation Balloon System for the Treatment of Stress Urinary Incontinence in Females.” Neurourology and Urodynamics 35 (2): 252–259.
Chicago author-date (all authors)
Wyndaele, Jean-Jacques, Stefan De Wachter, Giovanni A Tommaselli, Roberto Angioli, Michel J de Wildt, Karel Everaert, Dirk PJ Michielsen, and Gommert A Van Koeveringe. 2016. “A Randomized, Controlled Clinical Trial of an Intravesical Pressure-attenuation Balloon System for the Treatment of Stress Urinary Incontinence in Females.” Neurourology and Urodynamics 35 (2): 252–259.
Vancouver
1.
Wyndaele J-J, De Wachter S, Tommaselli GA, Angioli R, de Wildt MJ, Everaert K, et al. A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females. NEUROUROLOGY AND URODYNAMICS. 2016;35(2):252–9.
IEEE
[1]
J.-J. Wyndaele et al., “A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females,” NEUROUROLOGY AND URODYNAMICS, vol. 35, no. 2, pp. 252–259, 2016.
@article{6952058,
  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.},
  author       = {Wyndaele, Jean-Jacques and De Wachter, Stefan and Tommaselli, Giovanni A and Angioli, Roberto and de Wildt, Michel J and Everaert, Karel and Michielsen, Dirk PJ and Van Koeveringe, Gommert A},
  issn         = {0733-2467},
  journal      = {NEUROUROLOGY AND URODYNAMICS},
  keywords     = {bladder control,balloon,intravesical,pressure-attenuation,stress urinary incontinence,urinary incontinence},
  language     = {eng},
  number       = {2},
  pages        = {252--259},
  title        = {A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females},
  url          = {http://dx.doi.org/10.1002/nau.22708},
  volume       = {35},
  year         = {2016},
}

Altmetric
View in Altmetric
Web of Science
Times cited: