AIMS: To investigate the effectiveness of a novel personalized extracorporeal biofeedback device (Anykegel) for pelvic floor muscle training (PFMT) on the recovery of postprostatectomy urinary incontinence (PPI) after robot-assisted laparoscopic radical prostatectomy (RARP) through a randomized controlled trial. METHODS: A total of 84 patients who underwent RARP were randomized either to the intervention group (42) (receiving biofeedback-PFMT using a novel device in addition to verbal and written instruction) or to the control group (42). Patients were evaluated 1, 2, and 3 months after surgery. Incontinence severity was measured by the 24-hour pad test. The International Prostate Symptom Score (IPSS) and the International Index of Erectile Function (IIEF-5) questionnaire were also assessed. RESULTS: The intervention group showed a significantly smaller volume of urine loss at the 1-month follow-up than the control group on a 24-hour pad test (71.0 g vs 120.8 g; P = .028). However, from the 2-month follow-up visit, no significant differences were observed between the two groups. In addition, in the 1-month follow-up data of the IPSS-total score, the intervention group demonstrated significantly favorable changes from baseline with improved scores compared to the control group (0.25 ± 9.15 vs -3.81 ± 8.98; P = .046). Regarding the IIEF-5 score changes, no significant differences were reported throughout the study periods. CONCLUSIONS: The personalized extracorporeal biofeedback device for PFMT offers a significant positive effect on the recovery of PPI after RARP, especially in the early postoperative period. Furthermore, patients can be offered more convenience through performing the regular exercise at any place with ease.
RCT Entities:
AIMS: To investigate the effectiveness of a novel personalized extracorporeal biofeedback device (Anykegel) for pelvic floor muscle training (PFMT) on the recovery of postprostatectomy urinary incontinence (PPI) after robot-assisted laparoscopic radical prostatectomy (RARP) through a randomized controlled trial. METHODS: A total of 84 patients who underwent RARP were randomized either to the intervention group (42) (receiving biofeedback-PFMT using a novel device in addition to verbal and written instruction) or to the control group (42). Patients were evaluated 1, 2, and 3 months after surgery. Incontinence severity was measured by the 24-hour pad test. The International Prostate Symptom Score (IPSS) and the International Index of Erectile Function (IIEF-5) questionnaire were also assessed. RESULTS: The intervention group showed a significantly smaller volume of urine loss at the 1-month follow-up than the control group on a 24-hour pad test (71.0 g vs 120.8 g; P = .028). However, from the 2-month follow-up visit, no significant differences were observed between the two groups. In addition, in the 1-month follow-up data of the IPSS-total score, the intervention group demonstrated significantly favorable changes from baseline with improved scores compared to the control group (0.25 ± 9.15 vs -3.81 ± 8.98; P = .046). Regarding the IIEF-5 score changes, no significant differences were reported throughout the study periods. CONCLUSIONS: The personalized extracorporeal biofeedback device for PFMT offers a significant positive effect on the recovery of PPI after RARP, especially in the early postoperative period. Furthermore, patients can be offered more convenience through performing the regular exercise at any place with ease.