Enabling Self-Care for Pessary Users in Rural Setting
- Conditions
- Pelvic Organ Prolapse
- Registration Number
- NCT07084818
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Visual Analogue Score (VAS): satisfaction of prolapse management. Baseline, 3 months, 6 months Patient reported Visual Analogue Score for (0-100mm) for satisfaction of prolapse management.
- Secondary Outcome Measures
Name Time Method modified Patient Experience with Treatment and Self-Management (mPETS) Questionnaire Baseline, 6 months modified Patient Experience with Treatment and Self-Management Questionnaire. This is a 40-item questionnaire that is validated for patient experience with treatment and self-management of diseases as a measure of treatment burden. The questionnaire has been slightly modified to address how prolapse and pessary care impacts treatment burden.
Patient Experience with Pessary Treatment and Self-Management (PEPS) Questionnaire Baseline, 6 months Patient Experience with Pessary Treatment and Self-Management Questionnaire. This is a non-validated 11-item questionnaire that is focused on prolapse and pessary management.
Pelvic Floor Impact Questionnaire - 7 (PFIQ-7) This is a validated 7-item questionnaire that assesses treatment on pelvic floor impact. It has been used in many studies on prolapse, including preliminary studies on the Reia pessary. Pelvic Floor Impact Questionnaire - 7
Pessary Sexual Questionnaire Baseline, 6 months This is a non-validated 8-item questionnaire on sexual activity for subjects and whether the pessary impacts ability to be sexually active.
Patient Global Impression of Improvement (PGI-I) 3 months, 6 months Patient Global Impression of Improvement: Validated one-item questionnaire (Likert scale, 1-7)
Patient Global Impression of Severity (PGI-S) Baseline, 3 months, 6 months Patient Global Impression of Severity: Validated one-item assessment of severity of prolapse condition (Likert scale, 1-4)
Patient Global Symptoms Rating Scale (PGSC) Baseline, 3 months, 6 months Patient Global Symptoms Rating Scale (PGSC): Non-validated one-item questionnaire of treatment and adequacy of control of symptoms (Likert scale, 1-5)
Number of subjects with at least one adverse event 0-6 months Adverse events will be collected, including discharge, bleeding, pain during the course of the study in both the intervention group and the continued office-based care group.
Log of pessary self-care events 0-6 months Patients who decide to learn self-management of their pessary will record the number of times they remove and reinsert the pessary.