Study of a New Customizable Pessary Device for Treating Pelvic Organ Prolapse in Adult Women

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.

Evaluation of a Personalizable Pessary for Pelvic Organ Prolapse