Patient Education in the Clinical Management of Pessary

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06432218
• Other study ID #: K5558
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: November 2026

Study information

• Verified date: May 2024
• Source: Peking Union Medical College Hospital
• Contact: Ying Zhou, MD
• Phone: +8613681253992
• Email: shellypumch[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (9)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Changsha Hospital for Maternal and Child Health Care, Foshan Women and Children Hospital, Hangzhou Women's Hospital, Peking University People's Hospital, Shandong University, Shenzhen People's Hospital, Third Military Medical University, Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Knowledge of pessary	Self-rated score from 0 to 10 points (higher scores mean a better outcome).	Baseline and at pessary fitting.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Treatment-related symptoms and complications	Self report and physical examination.	3 and 12 months after successful pessary fitting.
Secondary	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.
Secondary	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.
Secondary	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.