Pelvic floor training with biofeedback has been shown to significantly reduce symptoms of urinary incontinence. The present study aimed to evaluate the effectiveness of pelvic floor training with the ACTICORE1 biofeedback device, which uses a noninsertable pelvic floor sensor with a digital interface.
A multicenter randomized controlled clinical pilot study in Germany was conducted between October 2021 and January 2022. The intervention group was instructed to use ACTICORE1 for 6 min daily to train the pelvic floor for 12 weeks. The control group was instructed not to do any pelvic floor training. Over 18-year-old men and women with urinary incontinence and an International Consultation on Incontinence Questionnaire score (ICIQ) of ≥5 were included in the study. The primary endpoint was the ICIQ score 12 weeks after enrollment. The secondary endpoints were the ICIQ score and quality of life using the EG-5D-3L questionnaire 4, 8, and 12 weeks after patients' enrollment.
A total of 40 individuals with urinary incontinence were recruited for the present study (35 females, 5 males; 40% lost to follow-up). In terms of biometric data, both groups did not differ. At 4, 8, and 12 weeks, the ICIQ scores of those in the ACTICORE1 group decreased from 12.9 to 7.5. The ICIQ score in the control group decreased from 11.0 to 10.5. The intraindividual improvement of patients in the ACTICORE group was statistically significant.
Biofeedback training with ACTICORE1 significantly reduces symptoms of urinary incontinence after 12 weeks.
Annals of medicine and surgery (2012). 2023 Aug 18*** epublish ***
Christoph Paasch, Sonja Soeder, Eric Lorenz, Sophie Heisler, Matthias Götze, Hendrik Borgmann, Julia Olthoff, Michael Hünerbein, Richard Hunger, René Mantke
University Hospital Brandenburg an der Havel, Brandenburg Medical University., Physiotherapy Practice Soeder, Berlin., Visceral Vascular Surgery, Minimally Invasive Surgery Alexianer St. Hedwig Hospital., Department of Surgery, Oberhavel Klinik Oranienburg, Oranienburg, Germany., Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontane, Brandenburg.