Patient Education in the Clinical Management of Pessary

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Other: video education; Other: conventional education

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying Zhou, MD; Phone Number: +8613681253992; Email: shellypumch@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital
      • Contact: Ying Zhou, MD; Phone Number: +8613681253992; Email: shellypumch@163.com
      • Principal Investigator: Lan Zhu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Symptomatic pelvic organ prolapse of stage II~IV
• Ability to participate in clinical trial and follow-up
• The patient and family understand the study, are willing to participate in the 1-year study, and provide written informed consent

Exclusion Criteria:

• Acute phase of infection of the internal and/or external genital tracts
• Genital fistula
• Suspected or untreated lower genital tract tumors
• Abnormally elevated intra-abdominal pressure (e.g., ascites, tumors)
• Life expectancy less than 1 year
• Cognitive or language communication disorders
• Unable to watch video (e.g., blindness)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the conventional education plus video education group; Watch video as well as receive conventional guidance.	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.
Active Comparator: the conventional education group; Receive conventional guidance.	Other: conventional education; Conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continued usage with satisfaction	Continued usage of the pessary and have very much or much improvement in the patient impression of improvement (PGI-I) questionnaire at 1 year.	12 months after pessary fitting.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of pessary	Self-rated score from 0 to 10 points (higher scores mean a better outcome).	Baseline and at pessary fitting.
Willingness to treatment	Self-rated score from 0 to 10 points (higher scores mean a better outcome).	Baseline, at pessary fitting, and 3 and 12 months after successful pessary fitting.
Anxiety about pessary use	7-item generalized anxiety disorder questionnaire (GAD-7) (the range of scores is 0-21, and higher scores mean a worse outcome), and self-rated score of sleep quality from 0 to 10 points (higher scores mean a better outcome).	Baseline and at pessary fitting.
Ability to self-manage	Self-rated score from 0 to 10 points (higher scores mean a better outcome).	3 and 12 months after successful pessary fitting.
Treatment-related symptoms and complications	Self report and physical examination.	3 and 12 months after successful pessary fitting.
Improvement in symptoms	Pelvic floor impact questionnaire-7 (PFIQ-7) (the range of scores is 0-300, and higher scores mean a worse outcome)	3 and 12 months after successful pessary fitting.
Improvement in quality of life	Pelvic floor distress inventory-20 (PFDI-20) (the range of scores is 0-300, and higher scores mean a worse outcome)	3 and 12 months after successful pessary fitting.
Improvement in sexual activity	The pelvic organ prolapse/urinary incontinence sexual questionnaire short form (PISQ-12) (the range of scores is 0-48, and higher scores mean a worse outcome)	3 and 12 months after successful pessary fitting.

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Shandong University; Peking University People's Hospital; Tongji Hospital; Third Military Medical University; Shenzhen People's Hospital; Foshan Women and Children Hospital; Hangzhou Women's Hospital; Changsha Hospital for Maternal and Child Health Care
• Investigators: Principal Investigator: Lan Zhu, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: K5558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No