Early Feasibility Study of the Reia Vaginal Pessary

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2020

Interventions

  • Device: Reia Vaginal Pessary
    • Reia Vaginal Pessary

Arms, Groups and Cohorts

  • Experimental: Reia Vaginal Pessary

Clinical Trial Outcome Measures

Primary Measures

  • To assess 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 (by measuring the distance from each pessary’s leading edge to the hymen)
    • Time Frame: 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.
  • To assess the ability of the study device to be retained throughout regular activity (by vaginal examination)
    • Time Frame: 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.

Secondary Measures

  • To assess the shape of the study pessary during expulsion if it is not able to be retained (by vaginal examination)
    • Time Frame: 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.
  • To assess the orientation of the study pessary stem following regular activity (by vaginal examination)
    • Time Frame: 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.
  • To assess the discomfort experienced with removal of the subject’s current pessary compared to the discomfort experienced with removal of the study pessary (by visual analog scale)
    • Time Frame: 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.
  • To assess the discomfort experienced with insertion of the subject’s current pessary compared to the discomfort experienced with insertion of the study pessary (by VAS)
    • Time Frame: 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.
  • To globally assess the comfort associated with use of the study pessary (by verbal description)
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Women with Stage II pelvic organ prolapse or greater
  • Current Gellhorn pessary users inclusive of sizes 2.25"-3"
  • Capable of giving informed consent

Exclusion Criteria

  • Pregnancy
  • Deep vaginal erosion noted with removal of original pessary
  • Presence of vesicovaginal fistula
  • Presence of rectovaginal fistula
  • Vaginal, rectal, or bladder tumor
  • 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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Reia, LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kris Strohbehn, MD, Principal Investigator, Dartmouth-Hitchcock Clinic
  • Overall Contact(s)
    • Paul Hanissian, MD, 603-715-7017, paul@reiahealth.com

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