Actively Recruiting
Evaluation of a Novel Personalizable Pessary for the Treatment of Pelvic Organ Prolapse
Led by University of Alberta · Updated on 2026-06-04
43
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Alberta
Lead Sponsor
A
Alberta Innovates Health Solutions
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pelvic organ prolapse (POP) affects about half of Canadian women during their lifetime, causing symptoms like urine leakage, discomfort, and embarrassment. This condition involves organs such as the bladder, uterus, and bowel pushing into the vagina. Researchers are evaluating a new personalizable pessary designed with a natural vaginal shape, which is easier to use and custom fit, compared to traditional pessaries. The study aims to assess the safety and effectiveness of this novel device for managing POP symptoms and improving quality of life. Participants who have previously used a standard pessary will first continue with their usual pessary for one month. Then, they will use the new personalizable pessary for three months. This device is made from biocompatible silicone and is produced using 3D printing technology to allow a better fit and easier self-care. The study will compare symptom changes, comfort, ease of use, and any side effects between the traditional and new pessaries. During the study, participants will complete questionnaires about their POP symptoms, sexual function, and quality of life. Researchers will also measure physical assessments and collect feedback on the pessaries’ comfort and self-management. The main outcome is the change in the Pelvic Floor Distress Inventory-20 score after using the new pessary. The total participation time is about four months, including one month with the standard device and three months with the new pessary. Safety and adherence will be closely monitored throughout the study.
CONDITIONS
Brief Title
Evaluation of a Personalizable Pessary for Pelvic Organ Prolapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients assigned female at birth
- At least 18 years old at time of screening
- Patients with symptomatic pelvic organ prolapse using a pessary for 3 months or more
- Capable of giving informed consent
- Fluency in English
You will not qualify if you...
- Pregnancy
- Short vaginal length (less than 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 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month
Participants use their standard pessary device as a control for comparison.
1 visit at start and 1 visit at end of this period
Duration - 3 months
Participants are fit with and use the novel personalizable pessary to assess its safety, efficacy, and ease of use.
Monthly visits during the treatment period
Trial Site Locations
Total: 1 location
1
Dale Sheard Centre for Solutions in Women's Health
Edmonton, Alberta, Canada, T5H3V9
Actively Recruiting
Research Team
M
May Sanaee, BSc MD FRCSC MHScEd
L
Laura Reyes Martinez, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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