Attitude and Success Rate of Women With Pelvic Organ Prolapse on Self-management of Vaginal Pessary

NCT06246721 | Completed DMC

• 1 other identifier: CREC 2023.603
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective cohort study aims at assessing patient's attitude towards self-management of vaginal pessary, and identifying factors that affect patient's level of acceptance towards self-management.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Prevalence of patients willing to learn self-management of vaginal pessary

  Questionnaire on attitude and knowledge will be asked. Descriptive analysis will be used to study the attitude of women on self-management of vaginal pessary. Prevalence of patients willing to learn self-management of vaginal pessary will be calculated.

  Baseline

Secondary Outcomes (4)

• Successful rate in self-management of vaginal pessary

  6 months follow up and 12 months follow up

• Patient's satisfaction on self-management of vaginal pessary

  6 months follow up and 12 months follow up

• Basic demographics questions

  Baseline, 6 months follow up and 12 months follow up

• Quality of life validated questionnaire (PFDI/PFIQ short form)

  Baseline, 6 months follow up and 12 months follow up

Study Arms (2)

Subjects Agree Self-management Group

ACTIVE COMPARATOR

Women with pelvic organ prolapse requires ring pessary for treatment. Those who agree to join the study and agree to learn how to self-management of vaginal pessary.

Behavioral: Self-management of vaginal pessary

Subjects Refuse Self-management Group

PLACEBO COMPARATOR

Women with pelvic organ prolapse requires ring pessary for treatment. Those who agree to join the study and refuse to learn how to self-management of vaginal pessary.

Behavioral: Self-management of vaginal pessary

Interventions

Self-management of vaginal pessary BEHAVIORAL

Self-management of vaginal pessary

Subjects Agree Self-management Group; Subjects Refuse Self-management Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who suffers from pelvic organ prolapse requiring use of vaginal ring pessary as treatment

You may not qualify if:

• Physically dependent in their daily living
• Limited physical dexterity due to medical conditions, for example: Parkinsonism or stroke
• Pregnancy
• Cognitive deficit preventing informed consenting procedure and self management
• Age lower than 18

Sponsors & Collaborators

• Kwong Wah Hospital: collaborator
• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Shing Chee Symphorosa CHAN

  O&G, PWH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Chief of Service (O&G), Clinical Associate Professor (honorary)

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 7, 2024
• Study Start: February 2, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)