title: Efficacy of an assisted low-intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial.
abstract: 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).
  
  
  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.affiliation: Department of Urology, Agostino Gemelli Hospital, Catholic University Medical School, Rome, Italy. danieletienforti@yahoo.it
authors.forename: Daniele
authors.initials: D
authors.lastname: Tienforti
authors.forename: Emilio
authors.initials: E
authors.lastname: Sacco
authors.forename: Francesco
authors.initials: F
authors.lastname: Marangi
authors.forename: Alessandro
authors.initials: A
authors.lastname: D'Addessi
authors.forename: Marco
authors.initials: M
authors.lastname: Racioppi
authors.forename: Gaetano
authors.initials: G
authors.lastname: Gulino
authors.forename: Francesco
authors.initials: F
authors.lastname: Pinto
authors.forename: Angelo
authors.initials: A
authors.lastname: Totaro
authors.forename: Daniele
authors.initials: D
authors.lastname: D'Agostino
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Bassi
mesh_terms: D000368:Aged; D005081:Exercise Therapy / Q000379:methods*; D025461:Feedback, Physiological / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017773:Pelvic Floor; D011183:Postoperative Complications / Q000209:etiology / Q000534:rehabilitation*; D011446:Prospective Studies; D011468:Prostatectomy / Q000534:rehabilitation*; D011471:Prostatic Neoplasms / Q000601:surgery*; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000209:etiology / Q000534:rehabilitation*