Early Feasibility Study of the Reia Vaginal Pessary

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-05

Study Completion Date

2021-01-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Pelvic Organ Prolapse Prolapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Reia Vaginal Pessary

Group Type EXPERIMENTAL

Reia Vaginal Pessary

Intervention Type DEVICE

Reia Vaginal Pessary

Interventions

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Reia Vaginal Pessary

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No