Evaluation of a Personalizable Pessary for Pelvic Organ Prolapse

NCT06954701 | Not Yet Recruiting DMC

• 1 other identifier: Pro00149345
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Pelvic Organ Prolapse (POP)

Keywords

Pelvic Organ Prolapse; Pessary

Outcome Measures

Primary Outcomes (1)

• Change in Pelvic Floor Distress Inventory-20 (PFDI-20) score

  Comparison of PFDI-20 scores between standard pessary and the study device. Score range 0-300, with higher scores indicating greater burden of pelvic floor symptoms.

  Approximately 4 months (1 month of standard pessary use and 3 months of study device use).

Secondary Outcomes (12)

• Change in Pelvic Floor Impact Questionnaire (PFIQ-7)

  Approximately 4 months (1 month of standard pessary use and 3 months of study device use).

• Change in Patient Global Impression of Improvement (PGI-I)

  Approximately 4 months (1 month of standard pessary use and 3 months of study device use).

• Change in the subscale Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6).

  Approximately 4 months (1 month of standard pessary use and 3 months of study device use).

• Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Urogynecologic Association-Revised (PISQ-IR)

  Approximately 4 months (1 month of standard pessary use and 3 months of study device use).

• Quality of life (QoL) questionnaire, i.e., the European-Quality of Life-5 Dimensions - 5 Levels (EQ-5D-5L)

  Approximately 4 months (1 month of standard pessary use and 3 months of study device use).

Other Outcomes (3)

• Study Pessary Fit

  Approximately 4 months (1 month of standard pessary use and 3 months of study device use).

• Patient Self-Management

  Approximately 4 months (1 month of standard pessary use and 3 months of study device use).

• Change in frequency of pessary removal for self-managers

  Approximately 4 months (1 month of standard pessary use and 3 months of study device use).

Study Arms (1)

Novel Personalizable Pessary Arm

OTHER

All patients in the study have previously been fit and used a standard pessary prior to the trial. They will use their standard pessary for one month. All participants will then be fit with a novel pessary, which they will use for 3 months.

Device: Novel Personalizable Pessary

Interventions

Novel Personalizable Pessary DEVICE

Novel personalizable pessary.

Novel Personalizable Pessary Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Innovates Health Solutions: collaborator
• Cosm Medical: collaborator

Study Sites (1)

Dale Sheard Centre for Solutions in Women's Health

Edmonton, Alberta, T5H3V9, Canada

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucas Vasas, MD

  University of Alberta

  STUDY DIRECTOR

Central Study Contacts

May Sanaee, BSc MD FRCSC MHScEd

CONTACT

1-780-735-5290; sanaee@ualberta.ca

Laura Reyes Martinez, PhD

CONTACT

780-964-9266; lreyes@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-Inferiority study. Patients will act as their own controls.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 1, 2025
• Study Start: April 20, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)