Status:
COMPLETED
Feasibility Study of the Reia Vaginal Pessary
Lead Sponsor:
Reia, LLC
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 fr...
Detailed Description
The purpose of this study is to evaluate the effectiveness, safety, function, and comfort of a novel vaginal pessary design for the treatment in women who suffer from of pelvic organ prolapse and who ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04508335
Start Date
November 21 2021
End Date
June 16 2023
Last Update
November 27 2024
Active Locations (7)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Boston Urogynecology Associates
Cambridge, Massachusetts, United States, 02138
3
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
4
New York Medical College
Hawthorne, New York, United States, 10532