title: A pilot randomized trial of conventional versus advanced pelvic floor exercises to treat urinary incontinence after radical prostatectomy: a study protocol.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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
  
  
  BACKGROUND
  Clinicalstrials.gov Identifier: NCT02233608.
authors.affiliation: University Health Network, Toronto, Ontario, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada. Daniel.santamina@utoronto.ca.|University of Guelph-Humber, 207 Humber College Boulevard, Toronto, Ontario, M9W 5L7, Canada. Daniel.santamina@utoronto.ca.|University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S 2W6, Canada. Daniel.santamina@utoronto.ca.
authors.forename: Daniel
authors.initials: D
authors.lastname: Santa Mina
authors.affiliation: University Health Network, Toronto, Ontario, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada. darren.au@uhn.ca.|University of Guelph, 50 Stone Rd E, Guelph, Ontario, N1G 2W1, Canada. darren.au@uhn.ca.
authors.forename: Darren
authors.initials: D
authors.lastname: Au
authors.affiliation: University Health Network, Toronto, Ontario, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada. shabbir.alibhai@uhn.ca.|University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S 2W6, Canada. shabbir.alibhai@uhn.ca.
authors.forename: Shabbir M H
authors.initials: SM
authors.lastname: Alibhai
authors.affiliation: University Health Network, Toronto, Ontario, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada. leah.jamnicky@uhn.ca.
authors.forename: Leah
authors.initials: L
authors.lastname: Jamnicky
authors.affiliation: Pelvic Health Solutions, 372 Hollandview Trail, Aurora, Ontario, L4G 0A5, Canada. nelly@pelvichealthsolutions.ca.
authors.forename: Nelly
authors.initials: N
authors.lastname: Faghani
authors.affiliation: University Health Network, Toronto, Ontario, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada. william.hilton@uhn.ca.|University of Guelph, 50 Stone Rd E, Guelph, Ontario, N1G 2W1, Canada. william.hilton@uhn.ca.
authors.forename: William J
authors.initials: WJ
authors.lastname: Hilton
authors.affiliation: University Health Network, Toronto, Ontario, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada. leslie.stefanyk@guelphhumber.ca.|University of Guelph-Humber, 207 Humber College Boulevard, Toronto, Ontario, M9W 5L7, Canada. leslie.stefanyk@guelphhumber.ca.
authors.forename: Leslie E
authors.initials: LE
authors.lastname: Stefanyk
authors.affiliation: York University, 4700 Keele St, Toronto, Ontario, M3J 1P3, Canada. pritvo@yorku.ca.|Cancer Care Ontario, Toronto, Ontario, Canada. pritvo@yorku.ca.
authors.forename: Paul
authors.initials: P
authors.lastname: Ritvo
authors.affiliation: University Health Network, Toronto, Ontario, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada. jennifer.jones@uhn.ca.|University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S 2W6, Canada. jennifer.jones@uhn.ca.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Jones
authors.affiliation: University Health Network, Toronto, Ontario, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada. dean.elterman@uhn.ca.|University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S 2W6, Canada. dean.elterman@uhn.ca.
authors.forename: Dean
authors.initials: D
authors.lastname: Elterman
authors.affiliation: University Health Network, Toronto, Ontario, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada. neil.fleshner@uhn.ca.|University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S 2W6, Canada. neil.fleshner@uhn.ca.
authors.forename: Neil E
authors.initials: NE
authors.lastname: Fleshner
authors.affiliation: University Health Network, Toronto, Ontario, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada. Antonio.finelli@uhn.ca.|University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S 2W6, Canada. Antonio.finelli@uhn.ca.
authors.forename: Antonio
authors.initials: A
authors.lastname: Finelli
authors.affiliation: University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S 2W6, Canada. rsing@tegh.on.ca.|Toronto East General Hospital, Toronto, Ontario, M4C 5T2, Canada. rsing@tegh.on.ca.
authors.forename: Rajiv K
authors.initials: RK
authors.lastname: Singal
authors.affiliation: University Health Network, Toronto, Ontario, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada. john.trachtenberg@uhn.ca.|University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S 2W6, Canada. john.trachtenberg@uhn.ca.
authors.forename: John
authors.initials: J
authors.lastname: Trachtenberg
authors.affiliation: University Health Network, Toronto, Ontario, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada. Andrew.matthew@uhn.ca.|University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S 2W6, Canada. Andrew.matthew@uhn.ca.
authors.forename: Andrew G
authors.initials: AG
authors.lastname: Matthew
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005081:Exercise Therapy / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D059952:Pelvic Floor Disorders / Q000209:etiology / Q000534:rehabilitation*; D010865:Pilot Projects; D011468:Prostatectomy / Q000009:adverse effects* / Q000534:rehabilitation*; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000175:diagnosis / Q000209:etiology* / Q000534:rehabilitation*