Patient Education in the Clinical Management of Pessary

N/ANot Yet RecruitingNCT06432218

Peking Union Medical College Hospital280 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

280

Conditions

Pelvic Organ Prolapse

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: 12 months after pessary fitting.

Secondary Outcomes

Knowledge of pessary

Self-rated score from 0 to 10 points (higher scores mean a better outcome).

Time frame: Baseline and at pessary fitting.

Willingness to treatment

Self-rated score from 0 to 10 points (higher scores mean a better outcome).

Time frame: 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).

Time frame: Baseline and at pessary fitting.

Ability to self-manage

Self-rated score from 0 to 10 points (higher scores mean a better outcome).