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NCT05812859 · ClinicalTrials.gov registry record · NA
Vaginal Orthosis Use After Vaginal Reconstructive Surgery
A NA study of Pelvic Organ Prolapse, sponsored by University of Alabama at Birmingham.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05812859: Active NA study of Pelvic Organ Prolapse, sponsored by University of Alabama at Birmingham.
NCT05812859 is a NA study of Pelvic Organ Prolapse that is active but no longer recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 30 participants, below the 144-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05812859, a NA study of Pelvic Organ Prolapse, is active but no longer recruiting, sponsored by University of Alabama at Birmingham.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
A novel vaginal orthosis, or splint, made of silicone will be used daily to help support the healing vaginal reconstruction during the post-operative phase from week 2 to week 12.
Primary Outcome
Pelvic exam will be performed at 12 months post-operative visit and POP-Q measurements will be performed. The "Ba" measurement will be used as the primary outcome comparing the measurements of the vaginal orthosis group and the standard of care group.
Conditions Studied
Interventions
- DEVICE Vaginal Orthosis (COSM Medical)
Study Locations (1)
Alabama
- UAB Hospital - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-01-29 |
| Est. Completion | 2026-07 |
| Phase | NA |
What the registry record for NCT05812859 still lists
NCT05812859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 144-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 1 intervention - of which Vaginal Orthosis (COSM Medical) is the first listed.
NCT05812859 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT05812859 about?
NCT05812859 is a clinical study titled "Vaginal Orthosis Use After Vaginal Reconstructive Surgery". A novel vaginal orthosis, or splint, made of silicone will be used daily to help support the healing vaginal reconstruction during the post-operative phase from week 2 to week 12.
What is the current status of trial NCT05812859?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-01-29. Estimated completion is 2026-07.
What conditions does trial NCT05812859 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse.
What interventions are being tested in trial NCT05812859?
The interventions under investigation include: Vaginal Orthosis (COSM Medical) (DEVICE).
Who is sponsoring clinical trial NCT05812859?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05812859 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05812859's enrollment target sits among peer trials
30 39th of 40 higher than 1 of 40 other Pelvic Organ Prolapse trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pelvic Organ Prolapse 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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