UNLABELLED: Study Type - Therapy (RCT) Level of Evidence 1b. What's known on the subject? and What does the study add? Peri-operative pelvic floor muscle training reduces urinary incontinence for men undergoing radical prostatectomy (RP). A preoperative biofeedback session, combined with postoperative pelvic floor muscle training, and assisted sessions on a monthly basis only, is an effective low-intensity programme to improve recovery of continence in patients undergoing RP. OBJECTIVE: To evaluate the efficacy of preoperative biofeedback (BFB) combined with an assisted low-intensity programme of postoperative perineal physiokinesitherapy in reducing the incidence, duration and severity of urinary incontinence (UI) in patients undergoing radical prostatectomy (RP). PATIENTS AND METHODS: A prospective, single-centre, randomized controlled clinical study was designed. • The intervention group received a training session with BFB, supervised oral and written instructions on Kegel exercises and a structured programme of postoperative exercises on the day before open RP. After RP, patients received control visits, including a session of BFB, at monthly intervals only. • The control group received, after catheter removal, only oral and written instructions on Kegel exercises to be performed at home. Patients received control visits at 1, 3 and 6 months after catheter removal. • At each visit the number of incontinence episodes, the number of pads used and patient-reported outcome measures (International Consultation on Incontinence Questionnaire on Urinary Incontinence [ICIQ-UI], [ICIQ]-Overactive Bladder [OAB], University of California, Los Angeles-Prostate Cancer Index [UCLA-PCI], International Prostate Symptom Score-Quality of Life [IPSS-QoL]) were assessed in both groups. All patients were followed-up for a period of at least 6 months after catheter removal. • The primary outcome was the recovery of continence, strictly defined as a ICIQ-UI score of zero. RESULTS: Overall, 34 consecutive patients were eligible and 32 were available for the final analysis: 16 patients for each study group. The two groups were homogeneous for all pre- and intraoperative features examined. • In the intervention group, continence had been achieved by six, eight and 10 patients at 1-, 3- and 6-month follow-ups, respectively, vs no patients (P= 0.02), one patient (P= 0.01) and one patient (P= 0.002) in the control group at each follow-up, respectively. • The analysis of the UCLA-PCI and ICIQ-OAB scores, the number of incontinence episodes per week and the number of pads per week showed significant differences in favour of patients in the intervention group at 3 and 6 months. • Patients in the intervention group reported better IPSS-QoL scores at all follow-up times but the difference did not reach statistical significance. CONCLUSIONS: Preoperative BFB combined with a postoperative programme of perineal physiokinesitherapy and assisted sessions on a monthly basis only, is a treatment strategy significantly more effective than the standard care in improving recovery of continence in patients undergoing RP. • The impact on QoL appeared less evident, although a trend for a better QoL was observed in the intervention group.
RCT Entities:
UNLABELLED: Study Type - Therapy (RCT) Level of Evidence 1b. What's known on the subject? and What does the study add? Peri-operative pelvic floor muscle training reduces urinary incontinence for men undergoing radical prostatectomy (RP). A preoperative biofeedback session, combined with postoperative pelvic floor muscle training, and assisted sessions on a monthly basis only, is an effective low-intensity programme to improve recovery of continence in patients undergoing RP. OBJECTIVE: To evaluate the efficacy of preoperative biofeedback (BFB) combined with an assisted low-intensity programme of postoperative perineal physiokinesitherapy in reducing the incidence, duration and severity of urinary incontinence (UI) in patients undergoing radical prostatectomy (RP). PATIENTS AND METHODS: A prospective, single-centre, randomized controlled clinical study was designed. • The intervention group received a training session with BFB, supervised oral and written instructions on Kegel exercises and a structured programme of postoperative exercises on the day before open RP. After RP, patients received control visits, including a session of BFB, at monthly intervals only. • The control group received, after catheter removal, only oral and written instructions on Kegel exercises to be performed at home. Patients received control visits at 1, 3 and 6 months after catheter removal. • At each visit the number of incontinence episodes, the number of pads used and patient-reported outcome measures (International Consultation on Incontinence Questionnaire on Urinary Incontinence [ICIQ-UI], [ICIQ]-Overactive Bladder [OAB], University of California, Los Angeles-Prostate Cancer Index [UCLA-PCI], International Prostate Symptom Score-Quality of Life [IPSS-QoL]) were assessed in both groups. All patients were followed-up for a period of at least 6 months after catheter removal. • The primary outcome was the recovery of continence, strictly defined as a ICIQ-UI score of zero. RESULTS: Overall, 34 consecutive patients were eligible and 32 were available for the final analysis: 16 patients for each study group. The two groups were homogeneous for all pre- and intraoperative features examined. • In the intervention group, continence had been achieved by six, eight and 10 patients at 1-, 3- and 6-month follow-ups, respectively, vs no patients (P= 0.02), one patient (P= 0.01) and one patient (P= 0.002) in the control group at each follow-up, respectively. • The analysis of the UCLA-PCI and ICIQ-OAB scores, the number of incontinence episodes per week and the number of pads per week showed significant differences in favour of patients in the intervention group at 3 and 6 months. • Patients in the intervention group reported better IPSS-QoL scores at all follow-up times but the difference did not reach statistical significance. CONCLUSIONS: Preoperative BFB combined with a postoperative programme of perineal physiokinesitherapy and assisted sessions on a monthly basis only, is a treatment strategy significantly more effective than the standard care in improving recovery of continence in patients undergoing RP. • The impact on QoL appeared less evident, although a trend for a better QoL was observed in the intervention group.
Authors: Coral A Anderson; Muhammad Imran Omar; Susan E Campbell; Kathleen F Hunter; June D Cody; Cathryn M A Glazener Journal: Cochrane Database Syst Rev Date: 2015-01-20
Authors: Vivian W Sung; Diane Borello-France; Gena Dunivan; Marie Gantz; Emily S Lukacz; Pamela Moalli; Diane K Newman; Holly E Richter; Beri Ridgeway; Ariana L Smith; Alison C Weidner; Susan Meikle Journal: Int Urogynecol J Date: 2016-06-10 Impact factor: 2.894