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Enrolling by invitation NCT07084818

Enabling Self-Care for Pessary Users in Rural Setting

No phase Interventional Pelvic Organ Prolapse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Reia System pessary self-care management, Standard pessary office-based management.
Who it may be relevant to
Registry conditions: Pelvic Organ Prolapse. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

This is a prospective interventional trial for patients with at least stage 2 pelvic organ prolapse (POP), who are currently managing their POP with office-based care using a pessary. The study will be conducted at two institutions, Dartmouth-Hitchcock and Pennsylvania State University. The intervention will be to convert willing patients from office-based care to self-care, using a new, collapsible (Reia) pessary in patients. The primary outcome will be a visual analog score (VAS) regarding their current satisfaction with their treatment and management of POP. Secondary outcomes will include questionnaires on impact, travel for care and self-care. The comparison group will be patients who decline to try the new pessary but agree to questionnaires regarding their current office-based care for pessary management.

Interventions

  • Device Reia System pessary self-care management
    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.
  • Device Standard pessary office-based management
    These subjects will continue with the current pessary they are using to manage their prolapse, with office-based care.

Primary outcome measures

  • Visual Analogue Score (VAS): satisfaction of prolapse management. [Time frame: Baseline, 3 months, 6 months]
Secondary outcome measures (9)
  • modified Patient Experience with Treatment and Self-Management (mPETS) Questionnaire [Time frame: Baseline, 6 months]
  • Patient Experience with Pessary Treatment and Self-Management (PEPS) Questionnaire [Time frame: Baseline, 6 months]
  • Pelvic Floor Impact Questionnaire - 7 (PFIQ-7) [Time frame: Baseline, 6 months]
  • Pessary Sexual Questionnaire [Time frame: Baseline, 6 months]
  • Patient Global Impression of Improvement (PGI-I) [Time frame: 3 months, 6 months]
  • Patient Global Impression of Severity (PGI-S) [Time frame: Baseline, 3 months, 6 months]
  • Patient Global Symptoms Rating Scale (PGSC) [Time frame: Baseline, 3 months, 6 months]
  • Number of subjects with at least one adverse event [Time frame: 0-6 months]
  • Log of pessary self-care events [Time frame: 0-6 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Dartmouth-Hitchcock Medical Center — Lebanon

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07084818 · 02003005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗