Enabling Self-Care for Pessary Users in Rural Setting

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Visual Analogue Score (VAS): satisfaction of prolapse management. [Срок оценки: Baseline, 3 months, 6 months]

Вторичные конечные точки (9)

• modified Patient Experience with Treatment and Self-Management (mPETS) Questionnaire [Срок оценки: Baseline, 6 months]
• Patient Experience with Pessary Treatment and Self-Management (PEPS) Questionnaire [Срок оценки: Baseline, 6 months]
• Pelvic Floor Impact Questionnaire - 7 (PFIQ-7) [Срок оценки: Baseline, 6 months]
• Pessary Sexual Questionnaire [Срок оценки: Baseline, 6 months]
• Patient Global Impression of Improvement (PGI-I) [Срок оценки: 3 months, 6 months]
• Patient Global Impression of Severity (PGI-S) [Срок оценки: Baseline, 3 months, 6 months]
• Patient Global Symptoms Rating Scale (PGSC) [Срок оценки: Baseline, 3 months, 6 months]
• Number of subjects with at least one adverse event [Срок оценки: 0-6 months]
• Log of pessary self-care events [Срок оценки: 0-6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Dartmouth-Hitchcock Medical Center — Lebanon

Публикации

• 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

Идентификаторы

NCT: NCT07084818 · 02003005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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