Early Feasibility Study of the Reia Vaginal Pessary

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Prolapse
• Intervention / Treatment: Device: Reia Vaginal Pessary

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reia Vaginal Pessary	Device: Reia Vaginal Pessary; Reia Vaginal Pessary

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Reia, LLC
• Investigators: Principal Investigator: Kris Strohbehn, MD, Dartmouth-Hitchcock Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: CP-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No