Recruiting

New Pessary

Sponsor:

University of Alberta

Code:

NCT06954701

Conditions

Pelvic Organ Prolapse (POP)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Novel Personalizable Pessary

Study Details

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)

Study ID

NCT06954701

Start date

Apr 30, 2026

Status verified date

Jun, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

43 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Novel Personalizable Pessary Arm

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.

Interventions

Novel Personalizable Pessary

Novel personalizable pessary.

Primary outcome measure

  • Change in Pelvic Floor Distress Inventory-20 (PFDI-20) score [ Time Frame: Approximately 4 months (1 month of standard pessary use and 3 months of study device use). ]

Central Contacts and Locations

Central contacts

May Sanaee, BSc MD FRCSC MHScEd

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

Laura Reyes Martinez, PhD

780-964-9266lreyes@ualberta.ca

Locations

Dale Sheard Centre for Solutions in Women's Health

Recruiting

Edmonton, Alberta, Canada, T5H3V9

Contacts

Principal Investigator:

May Sanaee, BSc MD FRCSC MHScEd

More Information

Sponsor

University of Alberta

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Pelvic Organ Prolapse
  • Pessary

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-06-04.