Artikel
The effect of biofeedback pelvic floor training with ACTICORE1 on urinary incontinence: A multicenter randomized clinical pilot trial
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Veröffentlicht: | 31. Oktober 2023 |
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Introduction: A pelvic floor training using biofeedback has been shown to significantly reduce symptoms of urinary incontinence. The study at hand aimed to evaluate the efficacy of the pelvic floor training with the biofeedback device ACTICORE1.
Methods: A multicenter randomized controlled clinical pilot study in Germany was and conducted between October 2021 and January 2022. The intervention group was instructed to use ACTICORE1 for 6 minutes daily to train the pelvic floor. The control group expected ACTCIORE1 training for 12 weeks and was instructed not to do any other training. Over 18-year-old men and women with urinary incontinence and an ICIQ score of ≥ 5 were included in the study. The primary endpoint was the The International Consultation on Incontinence Questionnaires (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.
Results: A total of 40 individuals with urinary incontinence was recruited for the present study (35 females; 40% Lost to follow-up). In terms of biometric data both groups did not differ. At 4, 8, and 12 weeks, the ICIQ score 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.
Conclusion: Biofeedback training with ACTICORE1 significantly reduces symptoms of urinary incontinence after 12 weeks.
Conflict of interest: Christoph Paasch and Sonja Soeder received remuneration for conducting the study from ACTICORE AG.