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Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence — ACT  

Urinary Incontinence Clinical Trial

Official title:
Clinical Investigation of an Adjustable Continence Therapy (ACT) Periurethral Prosthetic System for Treatment of Female Stress Urinary Incontinence With or Without Hypermobility

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 160 implanted female patients in which two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.

The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether the patients demonstrate at least a one-grade (mean) reduction in the Stamey score at 12 months.

Clinical Trial Description

This is a multi-center, prospective, non randomized clinical trial comparing baseline data to the 12 month data. Urodynamic testing, pad weights and a direct visual stress test will be used to determine success along with the Stamey score. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00113555
Study type Interventional
Source Uromedica
Contact
Status Completed
Phase N/A
Start date December 2001
Completion date November 2010
View Details
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