PMID- 37811051 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231030 IS - 2049-0801 (Print) IS - 2049-0801 (Electronic) IS - 2049-0801 (Linking) VI - 85 IP - 10 DP - 2023 Oct TI - The effect of biofeedback pelvic floor training with ACTICORE1 on urinary incontinence: a multicenter randomized clinical pilot trial. PG - 4860-4865 LID - 10.1097/MS9.0000000000001181 [doi] AB - BACKGROUND: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: Biofeedback training with ACTICORE1 significantly reduces symptoms of urinary incontinence after 12 weeks. CI - Copyright (c) 2023 The Author(s). Published by Wolters Kluwer Health, Inc. FAU - Paasch, Christoph AU - Paasch C AUID- ORCID: 0000-0003-3104-8288 AD - University Hospital Brandenburg an der Havel, Brandenburg Medical University. FAU - Soeder, Sonja AU - Soeder S AD - Physiotherapy Practice Soeder, Berlin. AD - Visceral Vascular Surgery, Minimally Invasive Surgery Alexianer St. Hedwig Hospital. FAU - Lorenz, Eric AU - Lorenz E AD - Visceral Vascular Surgery, Minimally Invasive Surgery Alexianer St. Hedwig Hospital. FAU - Heisler, Sophie AU - Heisler S AD - University Hospital Brandenburg an der Havel, Brandenburg Medical University. FAU - Gotze, Matthias AU - Gotze M AD - University Hospital Brandenburg an der Havel, Brandenburg Medical University. FAU - Borgmann, Hendrik AU - Borgmann H AD - University Hospital Brandenburg an der Havel, Brandenburg Medical University. FAU - Olthoff, Julia AU - Olthoff J AD - University Hospital Brandenburg an der Havel, Brandenburg Medical University. FAU - Hunerbein, Michael AU - Hunerbein M AD - Department of Surgery, Oberhavel Klinik Oranienburg, Oranienburg, Germany. FAU - Hunger, Richard AU - Hunger R AD - Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontane, Brandenburg. FAU - Mantke, Rene AU - Mantke R AD - University Hospital Brandenburg an der Havel, Brandenburg Medical University. AD - Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontane, Brandenburg. LA - eng PT - Journal Article DEP - 20230818 PL - England TA - Ann Med Surg (Lond) JT - Annals of medicine and surgery (2012) JID - 101616869 PMC - PMC10553154 OTO - NOTNLM OT - ACTICORE1 OT - biofeedback training OT - stress incontinence OT - urge incontinence OT - urinary incontinency COIS- C.P., R.H., and S.S. received payment for conducting the study from ACTICORE AG.Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article. EDAT- 2023/10/09 12:42 MHDA- 2023/10/09 12:43 PMCR- 2023/08/18 CRDT- 2023/10/09 06:12 PHST- 2023/06/29 00:00 [received] PHST- 2023/08/04 00:00 [accepted] PHST- 2023/10/09 12:43 [medline] PHST- 2023/10/09 12:42 [pubmed] PHST- 2023/10/09 06:12 [entrez] PHST- 2023/08/18 00:00 [pmc-release] AID - AMSU-D-23-01416 [pii] AID - 10.1097/MS9.0000000000001181 [doi] PST - epublish SO - Ann Med Surg (Lond). 2023 Aug 18;85(10):4860-4865. doi: 10.1097/MS9.0000000000001181. eCollection 2023 Oct.