Early Feasibility Study of the Reia Vaginal Pessary

NCT04275089 | Completed Results FDA Device

• 1 other identifier: CP-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse; Prolapse

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination)

  During treatment - within 1 hour

• Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination)

  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]

  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]

  During treatment - within 1 hour

• Global Comfort Associated With Use of the Study Pessary (by Verbal Description)

  Post treatment - within or at 1 hour

Study Arms (1)

Reia Vaginal Pessary

EXPERIMENTAL

Device: Reia Vaginal Pessary

Interventions

Reia Vaginal Pessary DEVICE

Reia Vaginal Pessary

Reia Vaginal Pessary

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reia, LLC: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kaitlin Maier
• Organization: Reia, LLC

kaitlin@reiahealth.com

2032742886

Study Officials

• Kris Strohbehn, MD

  Dartmouth-Hitchcock Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 19, 2020
• Study Start: November 5, 2020
• Primary Completion: January 20, 2021
• Study Completion: January 20, 2021
• Last Updated: July 28, 2023
• Results First Posted: July 28, 2023

Record last verified: 2022-09

Locations

US (1)