Status:
COMPLETED
Early Feasibility Study of the Reia Vaginal Pessary
Lead Sponsor:
Reia, LLC
Conditions:
Pelvic Organ Prolapse
Prolapse
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is an early feasibility open-label non-randomized trial to obtain preliminary information about the function and effectiveness of a novel vaginal pessary for the use in women who suffer from symp...
Eligibility Criteria
Inclusion
- Women with Stage II pelvic organ prolapse or greater
- Current ring style or Gellhorn pessary users inclusive of sizes 1.5"-3.5"
- Capable of giving informed consent
Exclusion
- Pregnancy
- Deep vaginal erosion noted with removal of current pessary
- Presence of vesicovaginal fistula
- Presence of rectovaginal fistula
- Vaginal, rectal, or bladder tumor
- Inflammatory Bowel Disease
- Presence of open wound or tear near vagina or anus by exam prior to removal of current pessary
- Current vaginal or urinary infection requiring treatment
- 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
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04275089
Start Date
November 5 2020
End Date
January 20 2021
Last Update
July 28 2023
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756