Feasibility Study of the Reia Vaginal Pessary

NCT04508335 | Completed Results FDA Device

• 1 other identifier: CP-002
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to obtain preliminary data on the effectiveness, safety, function, comfort, and patient satisfaction with a novel vaginal pessary design for the use in women who suffer from symptoms of pelvic organ prolapse (POP) and have already opted for non-surgical management. Recruited patients will have Stage II POP or greater and will be current users of a Gellhorn or ring style pessary. Following enrollment, each subject will enter a 1-month wash out period in which they will continue using their current pessary so that baseline subjective and objective data can be collected. They will then be fit with a study pessary and enter a 3-month treatment phase. Comparative, subjective, and objective data will be collected at the conclusion of the study.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

• Pelvic Floor Distress Inventory-20 (PFDI-20)

  The Pelvic Floor Distress Inventory - 20 (PFDI-20) is a validated instrument to assess the presence and bother of symptoms that pelvic floor disorders have on health-related quality of life in women. It is a 20-item questionnaire and the short form of the 46 question PFDI. There are three subscales: Urinary Distress Inventory 6 (UDI-6), Colorectal-Anal Distress Inventory 8 (CRADI-8), and the Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6). The overall score range is 0-300. The higher the score, the greater the perceived impact that pelvic floor dysfunction has on a patient's life. The minimal important change in the PFDI-20 to demonstrate a clinical effect in women choosing conservative management of their prolapse (i.e. a pessary) is between 13.5 and 18.3 points.

  At enrollment [Week 0] and post treatment [Week 16]

• Adverse Events

  Adverse events (AEs) reported by subjects and/or practitioners were recorded and categorized to conform to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 definition. AEs were then categorized into the groups as follows: New and/or worsening adverse events: AEs that were not present at baseline with the current pessary but developed with use of the Reia pessary, or that increased in severity with use of the Reia pessary. Improving adverse events: AEs that were present with the current pessary and decreased in severity or were no longer present with use of the Reia pessary. Persisting adverse events: AEs that were present both with the current pessary and with the Reia pessary but did not change in severity.

  Throughout study, an average of 16 weeks - AEs may be reported at any time

Secondary Outcomes (6)

• Pelvic Floor Impact Questionnaire (PFIQ-7)

  At enrollment [Week 0] and post treatment [Week 16]

• Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR)

  At enrollment [Week 0] and post treatment [Week 16]

• Objective Assessment of the Pessary's Ability to Support the Prolapse

  At enrollment [Week 0], during treatment [Week 3-5], during treatment [Week 5-7], and at the end of study [Week 16]

• Global Assessment of Study Pessary Satisfaction Compared to Current Pessary

  For current pessary at the end of washout period [Week 3-5]; For study pessary post treatment [Week 16]

• Pain Associated With Study Pessary Insertion Compared to Current Pessary

  During treatment [Week 3-5], during treatment [Week 5-7], and post treatment [Week 16]

Other Outcomes (4)

• Proportion of Patients Successfully Fit With the Study Pessary

  Post treatment [Week 16]

• Frequency of Pessary Removal for Self-managers

  End of washout period (current pessary use before treatment) [Weeks 3-5] and post treatment [Week 16]

• Ease of Insertion of Study Pessary by Subject for Self-managers

  End of washout period (current pessary use before treatment) [Weeks 3-5] and post treatment [Week 16]

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:

• Females with Stage II pelvic organ prolapse or greater
• Users of a Gellhorn or ring style pessary, inclusive of sizes 1.5"-3", for \>3 months' duration
• Capable of giving informed consent

You may not qualify if:

• Pregnancy Short vaginal length (total vaginal length \< 8 cm), or subjective vaginal narrowing
• Deep vaginal erosion noted with removal of current 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
• Untreated vaginal or urinary infection requiring treatment
• History of recurrent urinary tract or vaginal infections
• Inflammatory bowel disease
• Chronic pain syndromes of pelvic or anorectal origin
• 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
• Previous treatment failure with a pessary

Sponsors & Collaborators

• Reia, LLC: lead

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Boston Urogynecology Associates

Cambridge, Massachusetts, 02138, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

New York Medical College

Hawthorne, New York, 10532, United States

Location

Main Line Health

Media, Pennsylvania, 19063, United States

Location

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

Location

UTHealth

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Reia, LLC

paul@reiahealth.com

603 715-7017

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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 11, 2020
• Study Start: November 21, 2021
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: November 27, 2024
• Results First Posted: November 27, 2024

Record last verified: 2024-11

Locations

US (7)