Pelvic Floor Rehabilitation Study (Beckenboden-Rehabilitationsstudie - BREST)
Beckenboden-Rehabilitationsstudie (BREST)
1 other identifier
interventional
52
1 country
4
Brief Summary
This study compares the effectiveness of standard care, pelvic floor muscle training or vaginal pessary for the treatment of postpartum urinary incontinence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2018
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedFirst Submitted
Initial submission to the registry
September 4, 2023
CompletedFirst Posted
Study publicly available on registry
September 11, 2023
CompletedSeptember 11, 2023
September 1, 2023
2.7 years
September 4, 2023
September 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
patients' self-reported satisfaction with the treatment
12 weeks
Study Arms (3)
Standard care
ACTIVE COMPARATORPelvic floor muscle training
ACTIVE COMPARATORVaginal pessary
EXPERIMENTALInterventions
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 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.
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
You may qualify if:
- years or older
- gave birth within the 12 weeks prior to the postpartum visit
- postpartum urinary incontinence
- able to understand and give consent in German
You may not qualify if:
- any neurologic disease that impairs bladder function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Die GynPraxis
Alzey, Germany
Die GynPraxis
Bad Kreuznach, Germany
Die GynPraxis
Lampertheim, Germany
Die GynPraxis
Mainz, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
September 4, 2023
First Posted
September 11, 2023
Study Start
September 1, 2018
Primary Completion
April 30, 2021
Study Completion
August 31, 2021
Last Updated
September 11, 2023
Record last verified: 2023-09