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NCT00113555 · ClinicalTrials.gov registry record · NA
Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence
A NA study, sponsored by Uromedica.
- Completed
- Registry status
- NA
- Development phase
- 221
- Enrollment target
NCT00113555: Completed NA study, sponsored by Uromedica.
NCT00113555 is a NA study that has completed, run by Uromedica. The registered enrollment target is 221 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00113555, a NA study, has completed, sponsored by Uromedica.
- COMPLETED
- Registry status
- NA
- Development phase
- 221 participants
- Enrollment target
Study 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.
Primary Outcome
The Stamey grade classifies the severity of stress incontinence in four possible grades from 0-3. Grade 0: no leaking, Grade 1: loss of urine with sudden increases of abdominal pressure: e.g. coughing, sneezing or laughing, Grade 2: loss of urine with lesser degrees of stress: e.g. walking or standing up, and Grade 3: loss of urine without any relation to physical activity or position, e.g. while lying in bed. The primary end point at 12 months is a mean change in Stamey Grade from baseline of
Interventions
- DEVICE ACT (Adjustable Continence Therapy)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2001-12 |
| Est. Completion | 2010-11 |
| Phase | NA |
What the finished NCT00113555 record still lists
NCT00113555 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which ACT (Adjustable Continence Therapy) is the first listed.
NCT00113555 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00113555 about?
NCT00113555 is a clinical study titled "Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence". 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...
What is the current status of trial NCT00113555?
This trial is currently completed. It is a NA study. The enrollment target is 221 participants. The study started on 2001-12. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00113555?
The interventions under investigation include: ACT (Adjustable Continence Therapy) (DEVICE).
Who is sponsoring clinical trial NCT00113555?
This trial is sponsored by Uromedica, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00113555's enrollment target sits among peer trials
221 481st of 2000 higher than 1,520 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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