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NCT05493735 · ClinicalTrials.gov registry record · Phase 3
Lidocaine for Pessary Check Pain Reduction
A Phase 3 study of Pelvic Organ Prolapse and Stress Urinary Incontinence, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 3
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT05493735: Completed Phase 3 study of Pelvic Organ Prolapse and Stress Urinary Incontinence, sponsored by University of South Florida.
NCT05493735 is a Phase 3 study of Pelvic Organ Prolapse and Stress Urinary Incontinence that has completed, run by University of South Florida. The registered enrollment target is 66 participants, below the 144-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05493735, a Phase 3 study of Pelvic Organ Prolapse and Stress Urinary Incontinence, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to estimate the effect of lidocaine jelly on patient pain at the time of office pessary removal.
Primary Outcome
Self-reported pain level at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
Conditions Studied
Interventions
- DRUG Lidocaine Hcl 2% Jelly
- DRUG Placebo Jelly
Study Locations (1)
Florida
- USF Health Outpatient Urogynecology Clinics - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2022-09-08 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 3 |
What the finished NCT05493735 record still lists
NCT05493735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 144-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (54% lower).
The record links to 2 conditions, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 2 interventions - of which Lidocaine Hcl 2% Jelly is the first listed.
NCT05493735 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05493735 about?
NCT05493735 is a clinical study titled "Lidocaine for Pessary Check Pain Reduction". The primary objective of this study is to estimate the effect of lidocaine jelly on patient pain at the time of office pessary removal.
What is the current status of trial NCT05493735?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 66 participants. The study started on 2022-09-08. Estimated completion is 2023-06-30.
What conditions does trial NCT05493735 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse, Stress Urinary Incontinence.
What interventions are being tested in trial NCT05493735?
The interventions under investigation include: Lidocaine Hcl 2% Jelly (DRUG), Placebo Jelly (DRUG).
Who is sponsoring clinical trial NCT05493735?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05493735 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05493735's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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