Feasibility Study of the Reia Vaginal Pessary
Completed · Not applicable
Conditions studied: Pelvic Organ Prolapse
In brief
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.
Key facts
- Study ID
- NCT04508335
- Run by
- Reia, LLC
- People needed
- 78
- Starts
- 2021-11-21
- Expected to finish
- 2023-06-16
- Last updated by the study team
- 2024-11-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Females with Stage II pelvic organ prolapse or greater
- Users of a Gellhorn or ring style pessary, inclusive of sizes 1.5"-3", for >3 months' duration
- Capable of giving informed consent
You may not qualify if…
- Pregnancy Short vaginal length (total vaginal length < 8 cm), or subjective vaginal narrowing
- Deep vaginal erosion noted with removal of current pessary
- Presence of vesicovaginal fistula
- Presence of rectovaginal fistula
- Vaginal, rectal, or bladder tumor
- Presence of open wound or tear near vagina or anus by exam prior to removal of current pessary
- Untreated vaginal or urinary infection requiring treatment
- History of recurrent urinary tract or vaginal infections
- Inflammatory bowel disease
- Chronic pain syndromes of pelvic or anorectal origin
- Previous pelvic floor surgery in last 12 months
- Congenital malformation of bladder, rectum, or vagina
- Significant medical condition interfering with study participation (psychologic, neurologic, active drug/alcohol abuse, etc.)
- Planning pregnancy in next 6 months
- Previous treatment failure with a pessary
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Boston Urogynecology Associates — Cambridge, Massachusetts, United States
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
- New York Medical College — Hawthorne, New York, United States
- Main Line Health — Media, Pennsylvania, United States
- Women & Infants Hospital — Providence, Rhode Island, United States
- UTHealth — Houston, Texas, United States
Full record on ClinicalTrials.gov
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