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CompletedNCT06031870

Pelvic Floor Rehabilitation Study (Beckenboden-Rehabilitationsstudie - BREST)

Beckenboden-Rehabilitationsstudie (BREST)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
52 (actual)
Sponsor
Medical University of Vienna · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Conditions

Interventions

TypeNameDescription
DEVICEVaginal pessaryIn 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 careStandard 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 trainingTwelve 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.

Timeline

Start date
2018-09-01
Primary completion
2021-04-30
Completion
2021-08-31
First posted
2023-09-11
Last updated
2023-09-11

Locations

4 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT06031870. Inclusion in this directory is not an endorsement.