Early Feasibility Study of the Reia Vaginal Pessary

Reia, LLC

Status: Completed

Conditions: Pelvic Organ Prolapse; Prolapse

Treatments: Device: Reia Vaginal Pessary

Study type: Interventional

Funder types: Industry

Identifiers

NCT04275089

CP-001

Details and patient eligibility

About

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 symptoms of pelvic organ prolapse (POP). Recruited patients will have Stage II POP or greater and will be current users of a legally marketed vaginal pessary. In a single visit, data will be collected on the performance and comfort of the subject's current pessary. After placement of a study pessary, comparative data will be collected between subject's current pessary and the study pessary on ability to support prolapse. The study pessary's function will be assessed under controlled circumstances. The patient will have her current pessary replaced at the conclusion of the visit. Results will be used to inform future design modifications of the study pessary.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Reia Vaginal Pessary

Experimental group

Treatment:

Device: Reia Vaginal Pessary