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NCT02296099 · ClinicalTrials.gov registry record · Phase 4
Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence
A Phase 4 study of Urinary Incontinence,Stress, sponsored by TriHealth.
- Completed
- Registry status
- Phase 4
- Development phase
- 114
- Enrollment target
- 1
- Study location
NCT02296099: Completed Phase 4 study of Urinary Incontinence,Stress, sponsored by TriHealth.
NCT02296099 is a Phase 4 study of Urinary Incontinence,Stress that has completed, run by TriHealth. The registered enrollment target is 114 participants, below the 331-participant average among 5 other Urinary Incontinence,Stress trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02296099, a Phase 4 study of Urinary Incontinence,Stress, has completed, sponsored by TriHealth.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 114 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection.
Primary Outcome
A visual analog scale (VAS) will be used to have the patient rate her pain in the morning of postoperative day one. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG liposomal bupivacaine
Study Locations (1)
Ohio
- Cincinnati Urogynecology Associates - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-08 |
| Phase | Phase 4 |
What the finished NCT02296099 record still lists
NCT02296099 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 331-participant average among 5 other Urinary Incontinence,Stress trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Urinary Incontinence,Stress appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02296099 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02296099 about?
NCT02296099 is a clinical study titled "Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence". The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection.
What is the current status of trial NCT02296099?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 114 participants. The study started on 2014-11. Estimated completion is 2016-08.
What conditions does trial NCT02296099 study?
This clinical trial studies the following conditions: Urinary Incontinence,Stress.
What interventions are being tested in trial NCT02296099?
The interventions under investigation include: Placebo (DRUG), liposomal bupivacaine (DRUG).
Who is sponsoring clinical trial NCT02296099?
This trial is sponsored by TriHealth, which has 81 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02296099 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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