Pelvic Organ Prolapse
Conditions
Brief 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.
Interventions
OTHERvideo 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 verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting.
Sponsors
Peking University People's Hospital
Shandong University
Tongji Hospital
Third Military Medical University
Changsha Hospital for Maternal and Child Health Care
Hangzhou Women's Hospital
Shenzhen People's Hospital
Foshan Women's and Children's Hospital
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continued usage with satisfaction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of pessary | Baseline and at pessary fitting. | Self-rated score from 0 to 10 points (higher scores mean a better outcome). |
| Willingness to treatment | 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). |
| Ability to self-manage | 3 and 12 months after successful pessary fitting. | Self-rated score from 0 to 10 points (higher scores mean a better outcome). |
| Anxiety about pessary use | 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). |
| Improvement in symptoms | 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) |
| Improvement in quality of life | 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) |
| Improvement in sexual activity | 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) |
| Treatment-related symptoms and complications | 3 and 12 months after successful pessary fitting. | Self report and physical examination. |
Countries
China
Contacts
Primary ContactYing Zhou, MD
Outcome results
None listed