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NCT04171531 · ClinicalTrials.gov registry record · Phase 3
Sling vs Botox for Mixed Incontinence
A Phase 3 study, sponsored by NICHD Pelvic Floor Disorders Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT04171531: Completed Phase 3 study, sponsored by NICHD Pelvic Floor Disorders Network.
NCT04171531 is a Phase 3 study that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04171531, a Phase 3 study, has completed, sponsored by NICHD Pelvic Floor Disorders Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study Summary
The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.
Primary Outcome
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Interventions
- DRUG Botox® injection
- DEVICE Mid-urethral sling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-06-08 |
| Est. Completion | 2024-02-12 |
| Phase | Phase 3 |
What the finished NCT04171531 record still lists
NCT04171531 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Botox® injection is the first listed.
NCT04171531 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04171531 about?
NCT04171531 is a clinical study titled "Sling vs Botox for Mixed Incontinence". The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.
What is the current status of trial NCT04171531?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2020-06-08. Estimated completion is 2024-02-12.
What interventions are being tested in trial NCT04171531?
The interventions under investigation include: Botox® injection (DRUG), Mid-urethral sling (DEVICE).
Who is sponsoring clinical trial NCT04171531?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04171531's enrollment target sits among peer trials
150 1519th of 2000 higher than 455 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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