Early Feasibility Study of the Reia Vaginal Pessary

Not Applicable

Completed

Conditions: Prolapse
Pelvic Organ Prolapse

Interventions: Device: Reia Vaginal Pessary

Registration Number: NCT04275089

Lead Sponsor: Reia, LLC

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 15

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reia Vaginal Pessary	Reia Vaginal Pessary	-

Primary Outcome Measures

Name	Time	Method
The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination)	During treatment - within 1 hour	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.
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)	During treatment - within 1 hour	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.

Secondary Outcome Measures

Name	Time	Method
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]	During treatment - within 1 hour	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 \[VAS after insertion of current pessary\] - \[VAS after insertion of study pessary\].
Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination)	During treatment - within 1 hour	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.
Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination)	During treatment - within 1 hour	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.
Global Comfort Associated With Use of the Study Pessary (by Verbal Description)	Post treatment - within or at 1 hour	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.
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]	During treatment - within 1 hour	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 \[VAS after removal of current pessary\] - \[VAS after removal of study pessary\].