Enabling Self-Care for Pessary Users in Rural Setting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-10

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Self-Care

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

Group Type EXPERIMENTAL

Reia System pessary self-care management

Intervention Type 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.

Office-Care

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

Group Type ACTIVE_COMPARATOR

Standard pessary office-based management

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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collapsible pessary Ring pessary, Gellhorn pessary, donut pessary, cube pessary

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No