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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
| Shandong University | OTHER |
| Tongji Hospital | OTHER |
| Third Military Medical University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the conventional education plus video education group | Experimental | Watch video as well as receive conventional guidance. |
|
| the conventional education group | Active Comparator | Receive conventional guidance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| video education | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after pessary fitting. |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge of pessary | Self-rated score from 0 to 10 points (higher scores mean a better outcome). | Baseline and at pessary fitting. |
| Willingness to treatment | Self-rated score from 0 to 10 points (higher scores mean a better outcome). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Zhou, MD | Contact | +8613681253992 | shellypumch@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lan Zhu, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| Changsha Hospital for Maternal and Child Health Care | OTHER |
| Hangzhou Women's Hospital | UNKNOWN |
| Shenzhen People's Hospital | OTHER |
| Foshan Women's and Children's Hospital | OTHER |
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| conventional education | Other | Conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting. |
|
| 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). | Baseline and at pessary fitting. |
| Ability to self-manage | Self-rated score from 0 to 10 points (higher scores mean a better outcome). | 3 and 12 months after successful pessary fitting. |
| Treatment-related symptoms and complications | Self report and physical examination. | 3 and 12 months after successful pessary fitting. |
| Improvement in symptoms | Pelvic floor impact questionnaire-7 (PFIQ-7) (the range of scores is 0-300, and higher scores mean a worse outcome) | 3 and 12 months after successful pessary fitting. |
| Improvement in quality of life | Pelvic floor distress inventory-20 (PFDI-20) (the range of scores is 0-300, and higher scores mean a worse outcome) | 3 and 12 months after successful pessary fitting. |
| Improvement in sexual activity | 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) | 3 and 12 months after successful pessary fitting. |