Patient Education in the Clinical Management of Pessary

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

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.

Sponsors & Collaborators

• Peking University People's Hospital

  collaborator OTHER

• Shandong University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Third Military Medical University

  collaborator OTHER

• Changsha Hospital for Maternal and Child Health Care

  collaborator OTHER

• Hangzhou Women's Hospital

  collaborator UNKNOWN

• Shenzhen People's Hospital

  collaborator OTHER

• Foshan Women's and Children's Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  lead OTHER

Principal Investigators

• Lan Zhu, MD · Peking Union Medical College Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-30

Primary Completion

2026-11-30

Completion

2026-11-30

Countries

• China

Study Locations