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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 is a NA study that has completed, run by Uromedica. The registered enrollment target is 221 participants.
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.
Interventions
- DEVICE ACT (Adjustable Continence Therapy)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2001-12 |
| Est. Completion | 2010-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00113555
The ClinicalTrials.gov registry entry for NCT00113555 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 221 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Uromedica, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ACT (Adjustable Continence Therapy) is the first listed.
NCT00113555 reports 0 study locations.
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.
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