About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
video education
Other interventionA 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
Other interventionConventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting.
Treatment groups
Trial 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.
Secondary outcomes
Knowledge of pessary
Self-rated score from 0 to 10 points (higher scores mean a better outcome).
Willingness to treatment
Self-rated score from 0 to 10 points (higher scores mean a better outcome).
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).
Ability to self-manage
Self-rated score from 0 to 10 points (higher scores mean a better outcome).
Sponsors and contacts
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Peking Union Medical College Hospital
Lead sponsor
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
This trial is not recruiting at the moment. You can still explore other options: