New pessary system aims to ease pelvic organ prolapse management at home
NCT ID NCT06634459
First seen Jun 25, 2026 · Last updated Jul 24, 2026 · Updated 3 times
Summary
This study tests a new pessary system designed for easier home use in women with pelvic organ prolapse. About 200 women who have never used a pessary will be randomly assigned to either the new system or standard care. The main goal is to see if the new system leads to higher satisfaction over six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Reia System (pessary and applicator) or standard pessary (Gellhorn or ring)
- What this could lead to
- If successful, this could offer women with pelvic organ prolapse a more convenient and satisfying way to manage their condition at home.
- What could go wrong
- This is a relatively small, early-stage trial focused on satisfaction and ease of use, not a cure. The new device may not prove better than standard options and could have unforeseen complications.
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
-
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
-
About 218 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2024
- Expected to finish
-
Jan 2027
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * English-speaking natal females ≥ 18 years of age * Willing to self-maintain (insert/remove) pessary * Pessary naïve with Stage II-IV POP desiring conservative management with a pessary * Primary indication for use of pessary is treatment of pelvic organ prolapse Exclusion Criteria: * Primary indication for pessary use is for management of stress urinary incontinence * Prior mesh-augmented prolapse repair (i.e. transvaginal mesh, sacrocolpopexy) * Short vaginal length (TVL \< 8cm) or subjective vaginal narrowing * Vaginal fistula (e.g. rectovaginal, vesicovaginal or any type of fistula involving the vagina) * Vaginal, rectal or bladder malignancy * Genitourinary infection requiring treatment (See below 1) * Ongoing treatment for vaginal infections (e.g., chronic bacterial vaginosis) (See below 2) * 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 * Pregnant or planning pregnancy in the next 6 months * Prior failure of pessary for POP * History of hydroureter, hydronephrosis, or impaired renal function secondary to prolapse 1. Patients with acute vaginal infections will be eligible for enrollment 2 weeks after completing treatment with resolution of symptoms 2. OK to be on prophylactic/suppressive therapy for HSV
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pelvic organ prolapse are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
-
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27103, United States
-
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756, United States
-
MedStar Health
Washington D.C., District of Columbia, 20010, United States
-
Stanford University
Palo Alto, California, 94304, United States
-
The University of Chicago
Northbrook, Illinois, 60062, United States
-
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
-
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131, United States
-
University of Wisconsin
Madison, Wisconsin, 53711, United States
-
Women & Infants Hospital in Rhode Island
Providence, Rhode Island, 02903, 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?