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Completed

NCT Number: NCT06031870

Pelvic Floor Rehabilitation Study (Beckenboden-Rehabilitationsstudie - BREST)

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Die GynPraxis, Alzey, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vaginal pessary

Device

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.

Standard Care

Behavioral

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.

pelvic floor muscle training

Procedure

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 outcomes

  1. patients' self-reported satisfaction with the treatment

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Beckenboden-Rehabilitationsstudie (BREST)

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 11, 2023
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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