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Pelvic Floor Rehabilitation Study (Beckenboden-Rehabilitationsstudie - BREST)

Beckenboden-Rehabilitationsstudie (BREST)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06031870
Enrollment
52
Registered
2023-09-11
Start date
2018-09-01
Completion date
2021-08-31
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Urinary Incontinence

Brief summary

This study compares the effectiveness of standard care, pelvic floor muscle training or vaginal pessary for the treatment of postpartum urinary incontinence.

Interventions

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.

BEHAVIORALStandard 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.

PROCEDUREPelvic 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.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
patients' self-reported satisfaction with the treatment12 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026