Patient Education in the Clinical Management of Pessary

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Pelvic Organ Prolapse

Treatments: Other: conventional education; Other: video education

Study type: Interventional

Funder types: Other

Identifiers

NCT06432218

K5558

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups

the conventional education plus video education group

Experimental group

Description:

Watch video as well as receive conventional guidance.

Treatment:

Other: video education

Other: conventional education

the conventional education group

Active Comparator group

Description:

Receive conventional guidance.

Treatment:

Other: conventional education