Patient Education in the Clinical Management of Pessary

NCT06432218 | Not Yet Recruiting DMC

• 1 other identifier: K5558
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Knowledge of pessary

  Baseline and at pessary fitting.

• Willingness to treatment

  Baseline, at pessary fitting, and 3 and 12 months after successful pessary fitting.

• Anxiety about pessary use

  Baseline and at pessary fitting.

• Ability to self-manage

  3 and 12 months after successful pessary fitting.

• Treatment-related symptoms and complications

  3 and 12 months after successful pessary fitting.

Study Arms (2)

the conventional education plus video education group

EXPERIMENTAL

Watch video as well as receive conventional guidance.

Other: video education; Other: conventional education

the conventional education group

ACTIVE COMPARATOR

Receive conventional guidance.

Other: conventional education

Interventions

video education OTHER

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.

the conventional education plus video education group

conventional education OTHER

Conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting.

the conventional education group; the conventional education plus video education group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Peking University People's Hospital: collaborator
• Shandong University: collaborator
• Tongji Hospital: collaborator
• Third Military Medical University: collaborator
• Changsha Hospital for Maternal and Child Health Care: collaborator
• Hangzhou Women's Hospital: collaborator
• Shenzhen People's Hospital: collaborator
• Foshan Women's and Children's Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

• Lan Zhu, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Zhou, MD

CONTACT

+8613681253992; shellypumch@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 29, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)