None listed
Conditions
Brief summary
The aim of this study is to evaluate efficacy of a personalised pelvic floor muscle training program on urinary incontinence after radical prostatectomy. Who is it for? Individuals may be eligible to join this study if you aged 30-70 years and are scheduled to undergo radical prostatectomy (open or robotic) for prostate cancer. Study details Study participants will be allocated by chance to one of the three groups, Urethral muscle training, Conventional training or No training. Urethral muscle training will involve an individualised program of pelvic floor muscle training that relies on the principles of motor skill training of the striated muscles that control urethral pressure with ultrasound imaging used for assessment and biofeedback. Participants in both treatment groups will attend up to 10 sessions of pelvic floor muscle training supervised by a physiotherapist, and participants in the No treatment group will not receive treatment. Participants in the treatment groups will attend a session 1-2 weeks prior to surgery and will commence training before surgery. They will attend up to 9 sessions post-surgery, 1 week apart, commencing on catheter removal (~2 weeks post-surgery). This study will provide new insight into whether individualised pelvic floor muscle training is more effective than current treatments or no treatment for management of post-prostatectomy incontinence.
Interventions
(i) Urethral muscle training - comprehensive individualized program focused on training the striated muscles that pressurize the urethra. Exercise relies on the principles of motor skill training with trans-perineal ultrasound imaging for assessment (during voluntary contraction, coughing and a 60-s maximal contraction) and biofeedback. Training is based on assessment outcomes and commences with skill acquisition (training of optimal muscle recruitment patterns to increase urethral pressure). A key focus is the striated urethral sphincter, but with tailoring to include the other muscles, based on the assessment. Treatment is progressed using principles of exercise physiology according to a decision tool developed with the Clinical Advisory Committee. Based on the assessed needs and deficits of the patient, progression includes; training of sustained holding to enhance adaptation of striated muscles to provide ongoing maintenance of continence, training of ballistic efforts for episodes of increased bladder pressure (lifting, coughing, etc), skill development for functional training into broad range of activities including training with increasing bladder volumes, and high performance training for demanding tasks including strength training. Daily home exercise to practice tasks taught in each session is encouraged and monitored. Participants in Urethral training group will attend up to 10 sessions of face-to-face pelvic floor muscle training supervised by a physiotherapist. The number of sessions will be determined by the need for further training at the discretion of the treating physiotherapist or when the participant meets the criteria for continence defined as no urine loss for 5 days and no urine loss on the 24 hour pad test. Each session will last approximately 30 minutes. Participants will attend a session 1-2 weeks prior to surgery. Participants will commence training before surgery. They will attend up to 9 sessions post-surgery, 1 week apart, commencing on catheter removal (~2 weeks post-surgery). Adherence to treatment (home-based exercises) will be recorded using a weekly diary which will be inspected by the physiotherapist at each face-to-face treatment session. Participants will be instructed to perform their home-based exercise program with frequency and intensity guided by their capacity. Home exercises will involve practice of the tasks provided by their physiotherapist at the previous visit based on individualized assessment. Adherence to exercise will be encouraged by the physiotherapist and formally recorded monthly with other outcome measures using an online questionnaire.
Sponsors
Study design
Eligibility
Inclusion criteria
Men scheduled to undergo radical prostatectomy (open or robotic) for prostate cancer. Men will be included if they are able to attend assessment and rehabilitation sessions and are able to understand English.
Exclusion criteria
Main exclusion criteria are: (i) urinary incontinence prior to surgery; (ii) previous prostate or urethral surgery, (iii) assessment/training of pelvic floor muscles in preceding 6 months, (iv) scheduled to undergo or had previously undergone radiation therapy for prostate cancer.