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This study compares the effectiveness of standard care, pelvic floor muscle training or vaginal pessary for the treatment of postpartum urinary incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Active Comparator |
| |
| Pelvic floor muscle training | Active Comparator |
| |
| Vaginal pessary | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal pessary | Device | In the pessary group, all patients received a cube pessary, which was individually adapted to each patient. These pessaries exist in sizes 0 (25 mm edge length) to 9 (75 mm edge length). Patients were instructed by a physician or a trained nurse on how to autonomously manage the pessary, including daily changing and cleaning. After one week of treatment, all patients had an office visit to check if fitting was correct and if autonomous handling of the pessary was feasible. Treatment duration was 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| patients' self-reported satisfaction with the treatment | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Die GynPraxis | Alzey | Germany | ||||
| Die GynPraxis |
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| ID | Term |
|---|---|
| D010570 | Pessaries |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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|
| Standard care | Behavioral | Standard care consisted of a pelvic floor group exercise course led by a midwife, a physiotherapist, or an osteopath. Courses were in general once a week for a minimum of seven to a maximum of twelve weeks. The course was chosen by the patient, and the study team had no influence on the choice. |
|
| Pelvic floor muscle training | Procedure | Twelve pelvic floor physiotherapy sessions were prescribed by the study physician. Pelvic floor physiotherapy was performed in individual courses by trained physiotherapists. The patient was free to choose the physiotherapist and the study team had no influence on the choice. |
|
| Bad Kreuznach |
| Germany |
| Die GynPraxis | Lampertheim | Germany |
| Die GynPraxis | Mainz | Germany |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |