NCT07084818

Enabling Self-Care for Pessary Users in Rural Setting

Enrolling by Invitation
NAAges 18+InterventionalTreatment
Dartmouth-Hitchcock Medical Center
~120 participants
Updated 2025-11-24 on ClinicalTrials.gov
What's tested:Reia System pessary self-care managementStandard pessary office-based management

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Visual Analogue Score (VAS): satisfaction of prolapse management.
Measured over Baseline, 3 months, 6 months
Pelvic Organ Prolapse
1 sites across 1 states
New Hampshire1
  • Kris Strohbehn, MD · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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:
  • 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.