Trials / Completed
CompletedNCT00113555
Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence
Clinical Investigation of an Adjustable Continence Therapy (ACT) Periurethral Prosthetic System for Treatment of Female Stress Urinary Incontinence With or Without Hypermobility
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 221 (actual)
- Sponsor
- Uromedica · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ACT (Adjustable Continence Therapy) | surgically implanted device |
Timeline
- Start date
- 2001-12-01
- Primary completion
- 2008-07-01
- Completion
- 2010-11-01
- First posted
- 2005-06-09
- Last updated
- 2018-07-09
- Results posted
- 2018-06-04
Locations
7 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00113555. Inclusion in this directory is not an endorsement.