52
Participants
Start Date
September 1, 2018
Primary Completion Date
April 30, 2021
Study Completion Date
August 31, 2021
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.
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.
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.
Die GynPraxis, Alzey
Die GynPraxis, Bad Kreuznach
Die GynPraxis, Lampertheim
Die GynPraxis, Mainz
Medical University of Vienna
OTHER