Status:
NOT_YET_RECRUITING
Evaluation of a Personalizable Pessary for Pelvic Organ Prolapse
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Alberta Innovates Health Solutions
Cosm Medical
Conditions:
Pelvic Organ Prolapse (POP)
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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. Wo...
Detailed Description
Purpose: Pelvic organ prolapse (POP) impacts 50% of Canadian women in their lifetime. POP can be associated with voiding dysfunction, bowel dysfunction, and sexual dysfunction, thereby impacting quali...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06954701
Start Date
February 1 2026
End Date
October 1 2026
Last Update
January 7 2026
Active Locations (1)
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1
Dale Sheard Centre for Solutions in Women's Health
Edmonton, Alberta, Canada, T5H3V9