Enabling Self-Care for Pessary Users in Rural Setting

NCT07084818 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 02003005
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to see if a using new collapsible pessary (Reia pessary) for treatment of pelvic organ prolapse will allow patients to care for their prolapse on their own, rather than having to come to be seen by a provider in the office regularly (2-4 times per year) to manage the pessary. Enrollment in the study will be offered to current patients who have regular office visits to care for their pessary.

Conditions

Pelvic Organ Prolapse

Keywords

Pessary; Pelvic Organ Prolapse; Self-Care; Rural Care

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Score (VAS): satisfaction of prolapse management.

  Patient reported Visual Analogue Score for (0-100mm) for satisfaction of prolapse management.

  Baseline, 3 months, 6 months

Secondary Outcomes (9)

• modified Patient Experience with Treatment and Self-Management (mPETS) Questionnaire

  Baseline, 6 months

• Patient Experience with Pessary Treatment and Self-Management (PEPS) Questionnaire

  Baseline, 6 months

• Pelvic Floor Impact Questionnaire - 7 (PFIQ-7)

  Baseline, 6 months

• Pessary Sexual Questionnaire

  Baseline, 6 months

• Patient Global Impression of Improvement (PGI-I)

  3 months, 6 months

Study Arms (2)

Self-Care

EXPERIMENTAL

Subjects who switch to new, collapsible pessary and convert to self-management for care of their pelvic organ prolapse.

Device: Reia System pessary self-care management

Office-Care

ACTIVE COMPARATOR

Subjects who continue office-based pessary care of their pelvic organ prolapse with visits every 3-6 months annually.

Device: Standard pessary office-based management

Interventions

Reia System pessary self-care management DEVICE

The Reia-System pessary is an FDA-cleared device to manage pelvic organ prolapse which is collapsible and intended to be more easily removed, with less discomfort.

Also known as: collapsible pessary

Self-Care

Standard pessary office-based management DEVICE

These subjects will continue with the current pessary they are using to manage their prolapse, with office-based care.

Also known as: Ring pessary, Gellhorn pessary, donut pessary, cube pessary

Office-Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants are eligible females with pelvic organ prolapse (POP) who are currently managing with a pessary. POP is a gender-specific condition only affecting females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women currently using office-based pessary management of at least stage 2 POP will be recruited:
• English-speaking natal females 18 years or older
• Stage II-IV POP desiring continued pessary management.
• Primary indication for pessary management is treatment of POP

You may not qualify if:

• Primary indication for pessary is for management of stress urinary incontinence
• Vesicovaginal fistula or rectovaginal fistula
• Vaginal, rectal or bladder malignancy
• Genitourinary infection requiring treatment\*
• Ongoing treatment for vaginal infections (e.g., chronic bacterial vaginosis)\*
• Inflammatory bowel disease (Crohn's or ulcerative colitis)
• Pelvic or anorectal chronic pain
• Pelvic floor surgery within the past 6 months or planning to undergo pelvic floor surgery
• Congenital malformation of the bladder, rectum or vagina
• The following special populations will be excluded:
• Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women (or planning pregnancy in the next 6 months) (women of childbearing age will be verbally queried and offered pregnancy testing if uncertain) Prisoners
• \*Patients with acute vaginal infections will be eligible for enrollment 2 weeks after completing treatment and have resolution of symptoms

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Penn State University: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (9)

• Strohbehn K, Wadensweiler PM, Richter HE, Grimes CL, Rardin CR, Rosenblatt PL, Toglia MR, Siddiqui G, Hanissian P. Effectiveness and safety of a novel, collapsible pessary for management of pelvic organ prolapse. Am J Obstet Gynecol. 2024 Aug;231(2):271.e1-271.e10. doi: 10.1016/j.ajog.2024.05.009. Epub 2024 May 16.

  PMID: 38761837 BACKGROUND

• Strohbehn K, Wadensweiler P, Hanissian P. A novel, collapsible, space-occupying pessary for the treatment of pelvic organ prolapse. Int Urogynecol J. 2023 Jan;34(1):317-319. doi: 10.1007/s00192-022-05415-y. Epub 2022 Dec 3. No abstract available.

  PMID: 36462059 BACKGROUND

• Eton DT, Yost KJ, Lai JS, Ridgeway JL, Egginton JS, Rosedahl JK, Linzer M, Boehm DH, Thakur A, Poplau S, Odell L, Montori VM, May CR, Anderson RT. Development and validation of the Patient Experience with Treatment and Self-management (PETS): a patient-reported measure of treatment burden. Qual Life Res. 2017 Feb;26(2):489-503. doi: 10.1007/s11136-016-1397-0. Epub 2016 Aug 26.

  PMID: 27566732 BACKGROUND

• Chen X, Orom H, Hay JL, Waters EA, Schofield E, Li Y, Kiviniemi MT. Differences in Rural and Urban Health Information Access and Use. J Rural Health. 2019 Jun;35(3):405-417. doi: 10.1111/jrh.12335. Epub 2018 Nov 16.

  PMID: 30444935 BACKGROUND

• Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.

  PMID: 16021067 BACKGROUND

• Srikrishna S, Robinson D, Cardozo L. Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J. 2010 May;21(5):523-8. doi: 10.1007/s00192-009-1069-5. Epub 2009 Dec 15.

  PMID: 20013110 BACKGROUND

• Kearney R, Brown C. Self-management of vaginal pessaries for pelvic organ prolapse. BMJ Qual Improv Rep. 2014 Oct 21;3(1):u206180.w2533. doi: 10.1136/bmjquality.u206180.w2533. eCollection 2014.

  PMID: 27493737 BACKGROUND

• Dwyer L, Rajai A, Dowding D, Kearney R. Understanding Factors That Affect Willingness to Self-Manage a Pessary for Pelvic Organ Prolapse: A Questionnaire-Based Cross-Sectional Study of Pessary-Using Women in the UK. Int Urogynecol J. 2024 Aug;35(8):1627-1634. doi: 10.1007/s00192-024-05840-1. Epub 2024 Jul 2.

  PMID: 38953998 BACKGROUND

• Sung VW, Jeppson P, Madsen A. Nonoperative Management of Pelvic Organ Prolapse. Obstet Gynecol. 2023 Apr 1;141(4):724-736. doi: 10.1097/AOG.0000000000005121. Epub 2023 Mar 9.

  PMID: 36897185 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

• Kris Strohbehn, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention group will be subjects trying new collapsible pessary and providing self-care of their pessary. Control group will be subjects continuing with their current pessary and office-based care of their pessary.

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 25, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)