Pelvic Floor Rehabilitation Study (Beckenboden-Rehabilitationsstudie - BREST)

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT06031870

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Urinary Incontinence	Device: Vaginal pessary Behavioral: Standard care Procedure: Pelvic floor muscle training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Beckenboden-Rehabilitationsstudie (BREST)

Actual Study Start Date :

Sep 1, 2018

Actual Primary Completion Date :

Apr 30, 2021

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard care	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.
Active Comparator: Pelvic floor muscle training	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.
Experimental: Vaginal pessary	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.

Arm

Intervention/Treatment

Active Comparator: Standard care

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.

Active Comparator: Pelvic floor muscle training

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.

Experimental: Vaginal pessary

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.

Outcome Measures

Primary Outcome Measures

patients' self-reported satisfaction with the treatment [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Die GynPraxis	Alzey	Germany
2	Die GynPraxis	Bad Kreuznach	Germany
3	Die GynPraxis	Lampertheim	Germany
4	Die GynPraxis	Mainz	Germany

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Soren Lange, M.D., Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT06031870

Other Study ID Numbers:

2018-13832

First Posted:

Sep 11, 2023

Last Update Posted:

Sep 11, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Incontinence

Study Results

No Results Posted as of Sep 11, 2023