Enabling Self-Care for Pessary Users in Rural Setting

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT07084818
Status
Enrolling By Invitation

Conditions

  • Pelvic Organ Prolapse

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Oct 10, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Self-Care
    Subjects who switch to new, collapsible pessary and convert to self-management for care of their pelvic organ prolapse.
  • Active Comparator: Office-Care
    Subjects who continue office-based pessary care of their pelvic organ prolapse with visits every 3-6 months annually.

Primary Outcome Measure

Visual Analogue Score (VAS): satisfaction of prolapse management. [ Time Frame: Baseline, 3 months, 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-

Find similar trials in Lebanon, NH

By research site
Dartmouth-Hitchcock Medical Center· Lebanon, NH

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