Pelvic Floor Rehabilitation Study (Beckenboden-Rehabilitationsstudie - BREST)
NCT ID: NCT06031870
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2018-09-01
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard care
Standard care
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
Pelvic floor muscle training
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.
Vaginal pessary
Vaginal pessary
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.
Interventions
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Vaginal pessary
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.
Standard care
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
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.
Eligibility Criteria
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Inclusion Criteria
* gave birth within the 12 weeks prior to the postpartum visit
* postpartum urinary incontinence
* able to understand and give consent in German
Exclusion Criteria
* any neurologic disease that impairs bladder function
18 Years
FEMALE
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Soren Lange
M.D.
Locations
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Die GynPraxis
Alzey, , Germany
Die GynPraxis
Bad Kreuznach, , Germany
Die GynPraxis
Lampertheim, , Germany
Die GynPraxis
Mainz, , Germany
Countries
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Other Identifiers
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2018-13832
Identifier Type: -
Identifier Source: org_study_id
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