Trials / Completed
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Vaginal pessary | 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. |
| BEHAVIORAL | Standard 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. |
| PROCEDURE | Pelvic 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. |
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.