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NCT00277095 · ClinicalTrials.gov registry record · NA
ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males
A NA study, sponsored by Uromedica.
- Completed
- Registry status
- NA
- Development phase
- 123
- Enrollment target
NCT00277095: Completed NA study, sponsored by Uromedica.
NCT00277095 is a NA study that has completed, run by Uromedica. The registered enrollment target is 123 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00277095, a NA study, has completed, sponsored by Uromedica.
- COMPLETED
- Registry status
- NA
- Development phase
- 123 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for benign prostatic hyperplasia. 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 patients demonstrate at least a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at baseline.
Primary Outcome
The percentage of participants with 50% reduction in pad weight.
Interventions
- DEVICE ProACT (Adjustable Continence Therapy)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2005-08 |
| Est. Completion | 2017-12 |
| Phase | NA |
What the finished NCT00277095 record still lists
NCT00277095 is an interventional study that assigns participants to a tested intervention. The registered 123 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 (91% lower).
The record links to 0 conditions, and to 1 intervention - of which ProACT (Adjustable Continence Therapy) is the first listed.
NCT00277095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00277095 about?
NCT00277095 is a clinical study titled "ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males". The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on ...
What is the current status of trial NCT00277095?
This trial is currently completed. It is a NA study. The enrollment target is 123 participants. The study started on 2005-08. Estimated completion is 2017-12.
What interventions are being tested in trial NCT00277095?
The interventions under investigation include: ProACT (Adjustable Continence Therapy) (DEVICE).
Who is sponsoring clinical trial NCT00277095?
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 NCT00277095's enrollment target sits among peer trials
123 762nd of 2000 higher than 1,239 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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