Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
NCT Number: NCT06432218
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Beijing, Beijing Municipality, 100730, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting.
Time frame: 12 months after pessary fitting.
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: Baseline and at pessary fitting.
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.
Self-rated score from 0 to 10 points (higher scores mean a better outcome).
Time frame: Baseline and at pessary fitting.
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: 3 and 12 months after successful pessary fitting.
Self-rated score from 0 to 10 points (higher scores mean a better outcome).
Time frame: 3 and 12 months after successful pessary fitting.
Self report and physical examination.
Time frame: 3 and 12 months after successful pessary fitting.
Pelvic floor impact questionnaire-7 (PFIQ-7) (the range of scores is 0-300, and higher scores mean a worse outcome)
Time frame: 3 and 12 months after successful pessary fitting.
Pelvic floor distress inventory-20 (PFDI-20) (the range of scores is 0-300, and higher scores mean a worse outcome)
Time frame: 3 and 12 months after successful pessary fitting.
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)
Contact information is provided by the study sponsor or research team.
Peking Union Medical College Hospital
Other
A Randomized Controlled Trial of the Effectiveness of Patient Education in the Clinical Management of Pessary
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