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Evaluation of a Personalizable Pessary for Pelvic Organ Prolapse

RecruitingNAAges 18 Years - anyFemaleUniversity of Alberta
NCT06954701 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Pelvic organ prolapse (POP) is a common health issue. It will impact about half of Canadian women over their lifetime. With POP, organs like the bladder, uterus, and bowel may push into the vagina. Women may experience urine leakage, physical discomfort, and embarrassment. Aside from surgery, a common treatment for POP is the use of pessaries. Pessaries are removable devices placed inside the vagina that can relieve POP symptoms. Unfortunately, pessaries have fixed sizes and three in ten patients cannot find the right fit. Pessaries can cause bleeding and discomfort if they do not fit well or are not removed and cleaned regularly. Almost half of patients who wear pessaries stop using them because of these issues. There is a need for a better pessary treatment for patients. The investigators have developed a new pessary that has the natural shape of the vagina. This pessary is easier to

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients assigned female at birth * At least 18 years old at time of screening * Patients with symptomatic POP using a pessary for ≥ 3 months * Capable of giving informed consent * Fluency in English Exclusion Criteria: * Pregnancy * Short vaginal length (total vaginal length \<5 cm) or subjective vaginal narrowing * Vaginal erosion due to current pessary * Presence of vesicovaginal fistula * Presence of rectovaginal fistula * Current treatment for vaginal, rectal, or bladder tumor * Presence of open wound or tear near vagina or anus by exam prior to removal of current pessary * Presence of pelvic, vaginal, or urinary infection requiring treatment * Ongoing treatment of recurrent urinary tract or vaginal infections * Inflammatory bowel disease * Chronic pain syndromes of pelvic or anorectal origin * Previous pelvic floor surgery in last 12 months * Congenital malformation of bladder, rectum, or vagina * Significant medical condition interfering with study participation (psychologic, neurologic, active drug/alcohol abuse, ambulatory restrictions, etc.) * Planning pregnancy in next 6 months
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What it tests

  • Novel Personalizable Pessary
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Where

1 site
Dale Sheard Centre for Solutions in Women's Health
Edmonton, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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