Early Feasibility Study of the Reia Vaginal Pessary

Study Overview
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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.

Official Title
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Early Feasibility Prospective Open-Label Study to Assess the Function of a Novel Pessary for the Non-Surgical Management of Pelvic Organ Prolapse

Conditions
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Pelvic Organ Prolapse, Prolapse

Intervention / Treatment
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* Device: Reia Vaginal Pessary


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reia Vaginal Pessary<br> | Device: Reia Vaginal Pessary<br>* Reia Vaginal Pessary<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Ability of the Study Device to be Retained During Valsalva Compared to the Ability of the Subject's Current Pessary to be Retained During Valsalva (Change in Distance Between Current Pessary and Study Pessary to Leading Edge to the Hymen) | The subject will be asked to Valsalva with their current pessary in place, and the distance from the leading edge of the current pessary to the hymen will be measured in centimeters. After the current pessary is removed and with the study pessary in place, the subject will be asked to Valsalva again. The distance from the leading edge of the study pessary to the hymen will be measured in centimeters. In order to assess the ability of the study pessary to function and be retained, the measurements will be compared. | During treatment - within 1 hour | 
| The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination) | With the study pessary in place, the subject will be asked to ambulate for 10 minutes and attempt to void. Following these activities, whether the pessary was retained or expelled will be recorded. | During treatment - within 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination) | The subject will be asked to Valsalva. If the study device is expelled during Valsalva, whether the study device was expelled fully deployed or whether it prematurely folded to its collapsed state will be recorded. | During treatment - within 1 hour | 
| Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination) | Following ambulation and attempting to void and prior to removing the study pessary, it will be recorded if the study device's stem rotated out of its original inserted position. | During treatment - within 1 hour | 
| Discomfort Experienced With Removal of the Study Pessary Subtracted From the Discomfort Experienced With Removal of the Subject's Current Pessary (Change in VAS) [Positive Score Indicates Lower Discomfort With Study Pessary] | To indicate discomfort, the subject will be shown and asked to mark a visual analogue scale (VAS) after removal of her current pessary and before using the study pessary. The VAS will be a 10 centimeter linear continuum in which 0 represents no pain and 10 represents worst pain. After use of the study pessary and upon removal of the study pessary, the subject will be shown and asked to mark another VAS. In order to assess the discomfort experienced during removal of the study pessary, the distance from 0 to the subject's mark will be measured and compared between the two scales. The outcome measure is [VAS after removal of current pessary] - [VAS after removal of study pessary]. | During treatment - within 1 hour | 
| Discomfort Experienced With Insertion of the Study Pessary Subtracted From the Discomfort Experienced With Insertion of the Subject's Current Pessary (Change in VAS) [Positive Score Indicates Lower Discomfort With Study Pessary] | To indicate discomfort, the subject will be shown and asked to mark a VAS after insertion of the study pessary. The VAS will be a 10 centimeter linear continuum in which 0 represents no pain and 10 represents worst pain. After use of the study pessary and upon insertion of the subject's current pessary, the subject will also be shown and asked to mark another VAS. In order to assess the discomfort experienced during insertion of the study pessary, the distance from 0 to the subject's mark will be measured and compared between the two scales. The outcome measure is [VAS after insertion of current pessary] - [VAS after insertion of study pessary]. | During treatment - within 1 hour | 
| Global Comfort Associated With Use of the Study Pessary (by Verbal Description) | Following insertion of the subject's current pessary, and after the subject is dressed, she will be asked whether the study pessary was more, less, or as comfortable as her current pessary when it was in situ. If she responds it was more or less comfortable, she will be asked to describe why. | Post treatment - within or at 1 hour |