NCT06432218

Patient Education in the Clinical Management of Pessary

A Randomized Controlled Trial of the Effectiveness of Patient Education in the Clinical Management of Pessary

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized, controlled, single-blinded, multi-center clinical trial. Symptomatic patients with pelvic organ prolapse (POP) stage II, III or IV arranged to undergo pessary treatment will be randomized into either the experimental group or the control group. All patients will receive conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting, and the experimental group will receive additional patient education in the form of a re-watchable video. The video mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy. All patients will receive regular pessary fitting and be followed up for 1 year. Self-assessment questionnaires will be used to assess the patients' willingness to pessary treatment, anxiety status, treatment satisfaction and efficacy, and to assess the patients' self-management, complications and treatment adherence. Then the differences between the two groups will be compared.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
OTHER	video education	A re-watchable video provided before pessary fitting which mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy.
OTHER	conventional education	Conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting.

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-05-29
• Last updated: 2024-05-29

Locations

1 site across 1 country: China