The authors declare that they have no competing interests.
DSM, AGM, DA, WJH, and AGM collaboratively conceptualized the study objectives and methodology. SMHA, LJ, NF, LES assisted in further development of the protocol. JT, NEF, AF, DE, JJ, RKS and LJ support the project through protocol consultation and data collection. DSM, DA, AGM, LJ, and WJH will implement the protocol and oversee collection of the data. All authors have contributed to and approved this final manuscript.
DSM is the Program Lead for the Wellness and Exercise for Cancer Survivors Program (WE-Can) in ELLICSR at the Princess Margaret Cancer Centre and an Assistant Professor in the Faculty of Kinesiology and Physical Education at the University of Toronto. DA is an MSc candidate at the University of Guelph and Kinesiologist at WE-Can in ELLICSR at the Princess Margaret Cancer Centre. SMHA is a Staff Physician in the Department of Medicine at the University Health Network and a Senior Scientist with the Toronto General Research Institute. LJ is a Urologic Nurse at the Prostate Centre of the Princess Margaret Cancer Centre. NF is a Physiotherapist at Pelvic Health Solutions. WJH is an MSc candidate at the University of Guelph and Kinesiologist at WE-Can in ELLICSR at the Princess Margaret Cancer Centre. LES is the Assistant Program Head at the University of Guelph-Humber and a Kinesiologist at WE-Can in ELLICSR at the Princess Margaret Cancer Centre. PR is a Professor in the Faculty of Health at York University and a Senior Scientist with Cancer Care Ontario. JJ is an Associate Professor in the Department of Psychiatry, Faculty of Medicine at the University of Toronto and the Director of ELLICSR at the Princess Margaret Cancer Centre. DE is a Staff Urologist and the Medical Director of the Prostate Cancer Rehabilitation Clinic at the University Health Network. NEF is a Staff Surgeon, Clinician Scientist, and Head of the Division of Urology at the University Health Network and the Princess Margaret Cancer Centre, and a Professor in the Department of Surgery at the University of Toronto. AF is a Staff Surgeon and Clinician Scientist in the Division of Urology at the University Health Network, and an Assistant Professor in the Department of Surgical Oncology with the University of Toronto. RKS is a urologic surgeon at Toronto East General Hospital and Assistant Professor in the Department of Surgery at the University of Toronto. JT is a Professor of Surgery and Medical Imaging at the University of Toronto, a Staff Surgeon and Clinician Scientist in the Division of Urology and Director of the Prostate Centre at the Princess Margaret Cancer Centre. AGM is Senior Staff Psychologist and Clinician-Scientist in the Department of Surgery and the Department of Psychosocial Oncology and Palliative Care at the Princess Margaret Cancer Centre.
Radical prostatectomy is the most common and effective treatment for localized prostate cancer. Unfortunately, radical prostatectomy is associated with urinary incontinence and has a significant negative impact on quality of life. Pelvic floor exercises are the most common non-invasive management strategy for urinary incontinence following radical prostatectomy; however, studies provide inconsistent findings regarding their efficacy. One potential reason for sub-optimal efficacy of these interventions is the under-utilization of regional muscles that normally co-activate with the pelvic floor, such as the transverse abdominis, rectus abdominis, and the diaphragm. Two novel approaches to improve urinary continence recovery are ‘Pfilates’ and ‘Hypopressives’ that combine traditional pelvic floor exercises with the activation of additional supportive muscles. Our study will compare an advanced pelvic floor exercise training program that includes Pfilates and Hypopressives, to a conventional pelvic floor exercises regimen for the treatment of post-radical prostatectomy urinary incontinence.
This is a pilot, randomized controlled trial of advanced pelvic floor muscle training versus conventional pelvic floor exercises for men with localized prostate cancer undergoing radical prostatectomy. Eighty-eight men who will be undergoing radical prostatectomy at hospitals in Toronto, Canada will be recruited. Eligible participants must not have undergone androgen deprivation therapy and/or radiation therapy. Participants will be randomized 1:1 to receive 26 weeks of the advanced or conventional pelvic floor exercise programs. Each program will be progressive and have comparable exercise volume. The primary outcomes are related to feasibility for a large, adequately powered randomized controlled trial to determine efficacy for the treatment of urinary incontinence. Feasibility will be assessed via recruitment success, participant retention, outcome capture, intervention adherence, and prevalence of adverse events. Secondary outcomes of intervention efficacy include measures of pelvic floor strength, urinary incontinence, erectile function, and quality of life. Secondary outcome measures will be collected prior to surgery (baseline), and at 2, 6, 12, 26-weeks post-operatively.
Pfilates and Hypopressives are novel approaches to optimizing urinary function after radical prostatectomy. This trial will provide the foundation of data for future, large-scale trials to definitively describe the effect of these advanced pelvic floor exercise modalities compared to conventional pelvic floor exercise regimes for men with prostate cancer undergoing radical prostatectomy
Clinicalstrials.gov Identifier: NCT02233608.
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- A pilot randomized trial of conventional versus advanced pelvic floor exercises to treat urinary incontinence after radical prostatectomy: a study protocol
Daniel Santa Mina
Shabbir M. H. Alibhai
William J. Hilton
Leslie E. Stefanyk
Neil E. Fleshner
Rajiv K. Singal
Andrew G. Matthew
- BioMed Central
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