New collapsible pessary could free women from frequent doctor visits
NCT ID NCT07084818
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new collapsible pessary (Reia) for women with pelvic organ prolapse. The goal is to see if it allows patients to care for their prolapse on their own, instead of needing to visit a doctor 2-4 times per year. About 120 current pessary users will try the device and report their satisfaction.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can strength training steady the walk and strengthen the pelvic floor after menopause?
- Can a biological mesh improve pelvic floor surgery?
- Can targeted exercises ease mild pelvic organ prolapse without surgery?
- AI may predict which pelvic floor therapy works best
- Can a small pressure drop make prolapse surgery less painful?
- Could a simple surgical step make hysterectomies safer?