Evaluation of a Personalizable Pessary for Pelvic Organ Prolapse

Recruiting now · Not applicable

Conditions studied: Pelvic Organ Prolapse (POP)

In brief

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 remove and re-insert. The pessary is also custom fit for each patient. In this study, the investigators will compare our new pessary to traditional pessaries. Study participants who have been fit with a traditional pessary will be asked to use our new pessary design for 3 months. Study participants will fill out questionnaires about their POP symptoms. The investigators will also ask patients to provide their feedback on comfort and how easy it is to use the new pessary. This study could open up new possibilities for treating POP across Canada and around the world.

Key facts

Study ID

NCT06954701

Run by

University of Alberta

People needed

43

Starts

2026-04-30

Expected to finish

2026-10-01

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dale Sheard Centre for Solutions in Women's Health — Edmonton, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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