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NCT04508335 · ClinicalTrials.gov registry record · NA
Feasibility Study of the Reia Vaginal Pessary
A NA study of Pelvic Organ Prolapse, sponsored by Reia.
- Completed
- Registry status
- NA
- Development phase
- 78
- Enrollment target
- 7
- Study locations
NCT04508335: Completed NA study of Pelvic Organ Prolapse, sponsored by Reia.
NCT04508335 is a NA study of Pelvic Organ Prolapse that has completed, run by Reia. The registered enrollment target is 78 participants, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (45% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04508335, a NA study of Pelvic Organ Prolapse, has completed, sponsored by Reia.
- COMPLETED
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to obtain preliminary data on the effectiveness, safety, function, comfort, and patient satisfaction with a novel vaginal pessary design for the use in women who suffer from symptoms of pelvic organ prolapse (POP) and have already opted for non-surgical management. Recruited patients will have Stage II POP or greater and will be current users of a Gellhorn or ring style pessary. Following enrollment, each subject will enter a 1-month wash out period in which they will continue using their current pessary so that baseline subjective and objective data can be collected. They will then be fit with a study pessary and enter a 3-month treatment phase. Comparative, subjective, and objective data will be collected at the conclusion of the study.
Primary Outcome
The Pelvic Floor Distress Inventory - 20 (PFDI-20) is a validated instrument to assess the presence and bother of symptoms that pelvic floor disorders have on health-related quality of life in women. It is a 20-item questionnaire and the short form of the 46 question PFDI. There are three subscales: Urinary Distress Inventory 6 (UDI-6), Colorectal-Anal Distress Inventory 8 (CRADI-8), and the Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6). The overall score range is 0-300. The higher the sc
Conditions Studied
Interventions
- DEVICE Reia Vaginal Pessary
Study Locations (7)
Alabama
- University of Alabama at Birmingham - Birmingham
Massachusetts
- Boston Urogynecology Associates - Cambridge
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
New York
- New York Medical College - Hawthorne
Pennsylvania
- Main Line Health - Media
Rhode Island
- Women & Infants Hospital - Providence
Texas
- UTHealth - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2021-11-21 |
| Est. Completion | 2023-06-16 |
| Phase | NA |
What the finished NCT04508335 record still lists
NCT04508335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 1 intervention - of which Reia Vaginal Pessary is the first listed.
NCT04508335 lists 7 locations in 7 states (Alabama, Massachusetts, New Hampshire).
Frequently Asked Questions
What is clinical trial NCT04508335 about?
NCT04508335 is a clinical study titled "Feasibility Study of the Reia Vaginal Pessary". The purpose of this study is to obtain preliminary data on the effectiveness, safety, function, comfort, and patient satisfaction with a novel vaginal pessary design for the use in women who suffer from symptoms of pelvic organ prolapse (POP) and have already opted for non-surgical management. Recru...
What is the current status of trial NCT04508335?
This trial is currently completed. It is a NA study. The enrollment target is 78 participants. The study started on 2021-11-21. Estimated completion is 2023-06-16.
What conditions does trial NCT04508335 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse.
What interventions are being tested in trial NCT04508335?
The interventions under investigation include: Reia Vaginal Pessary (DEVICE).
Who is sponsoring clinical trial NCT04508335?
This trial is sponsored by Reia, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04508335 being conducted?
This trial has 7 study locations across Alabama, Massachusetts, New Hampshire, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04508335's enrollment target sits among peer trials
78 27th of 40 higher than 14 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.
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