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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
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
September 4, 2023
Last Updated
September 4, 2023
Sponsor
Medical University of Vienna
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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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