A continence promotion intervention involving a pelvic floor muscle rehabilitation exercise program to reduce lower urinary tract, lower bowel symptoms and erectile dysfunction in men receiving radiation therapy with or without androgen deprivation therapy (ADT): A Pilot Study

This pilot study aims to define the variation in endpoint measures in men who are prescribed radiation therapy (RT) with or without androgen deprivation therapy (ADT). This will allow the determination of a sample size sufficiently powered to detect such a difference so that a formal randomised controlled trial might be designed. Who is it for? This study is open to men aged 40-90 years with early stage prostate cancer, without any neurological conditions and absent from any other bladder conditions or secondary malignancies. You will not be eligible to participate if you have had any type of abdominal surgery in the past 2 years. You may also be allowed entry to this study if you are currently receiving radiation therapy with 6 months non-adjuvant androgen deprivation therapy, or NOT receiving (ADT) prior to beginning scheduled radiation therapy. Trial details: In this study, you will be randomised to one of two treatment arms. For Arm 1, if you are currently receiving radiation therapy with 6 months non-adjuvant androgen deprivation therapy (ADT) or NOT receiving ADT prior to beginning scheduled radiation therapy, you will receive a specifically designed continence promotion intervention including a tailored pelvic floor muscle rehabilitation exercise program to reduce lower urinary tract , lower bowel symptoms and erectile dysfunction. This intervention will be tailored to you and delivered one on one by a physiotherapist. All men in Arm 1 of the study will receive a copy of a pelvic floor exercise DVD which they will be encouraged to use. If you are receiving radiation therapy alone WITHOUT androgen deprivation therapy, you will meet with a physiotherapist for review immediately after your radiation therapy, and then at 1 and 3 months after it. If you ARE receiving ADT, you will need to exercise for 6 months prior to your scheduled radiotherapy, and these exercises will be tailored to you. For Arm 2, you will receive the current, usual care with no additional instructions when you undergo your radiation therapy, except in relation to having empty bladder and bowels at each radiation therapy session. All men in the study who are receiving Androgen Deprivation Therapy will be given the option to take part in “The Man Plan", an individually tailored general exercise and fitness regimen, which includes support, education and exercise options but with no attention paid to continence promotion or pelvic floor muscle function. The program will be supervised by local exercise physiologists and delivered in a format that suits you best.