Pelvic Floor Rehabilitation Study (Beckenboden-Rehabilitationsstudie - BREST)
Primary Purpose
Postpartum Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Vaginal pessary
Standard care
Pelvic floor muscle training
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Urinary Incontinence
Eligibility Criteria
Inclusion Criteria: 18 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 Exclusion Criteria: treatment for postpartum urinary incontinence that started prior to inclusion any neurologic disease that impairs bladder function
Sites / Locations
- Die GynPraxis
- Die GynPraxis
- Die GynPraxis
- Die GynPraxis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Standard care
Pelvic floor muscle training
Vaginal pessary
Arm Description
Outcomes
Primary Outcome Measures
patients' self-reported satisfaction with the treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT06031870
First Posted
September 4, 2023
Last Updated
September 4, 2023
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT06031870
Brief Title
Pelvic Floor Rehabilitation Study (Beckenboden-Rehabilitationsstudie - BREST)
Official Title
Beckenboden-Rehabilitationsstudie (BREST)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study compares the effectiveness of standard care, pelvic floor muscle training or vaginal pessary for the treatment of postpartum urinary incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
Active Comparator
Arm Title
Pelvic floor muscle training
Arm Type
Active Comparator
Arm Title
Vaginal pessary
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Vaginal pessary
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pelvic floor muscle training
Intervention Description
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.
Primary Outcome Measure Information:
Title
patients' self-reported satisfaction with the treatment
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 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
Exclusion Criteria:
treatment for postpartum urinary incontinence that started prior to inclusion
any neurologic disease that impairs bladder function
Facility Information:
Facility Name
Die GynPraxis
City
Alzey
Country
Germany
Facility Name
Die GynPraxis
City
Bad Kreuznach
Country
Germany
Facility Name
Die GynPraxis
City
Lampertheim
Country
Germany
Facility Name
Die GynPraxis
City
Mainz
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pelvic Floor Rehabilitation Study (Beckenboden-Rehabilitationsstudie - BREST)
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