Clinical trial NCT02233608: Advanced Pelvic Floor Training Program for Prostate Cancer Surgery
Official title: A Randomized Pilot Study of Conventional Versus Advanced Pelvic Floor Exercises to Treat Urinary Incontinence After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer Patients Undergoing Radical Prostatectomy
Keywords: Prostate cancer
Radical prostatectomy
Pelvic floor muscle exercises
Pfilates
Hypopressives
Urinary Incontinence
Lead sponsor: University of Guelph-Humber
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
name: University Health Network, Toronto
First posted: 2014-09-08
Enrollment: 88
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Radical prostatectomy is a common and effective treatment for prostate cancer but is associated with urinary incontinence that can persist for several months after surgery and significantly reduce quality of life. Studies have shown that routine performance of pelvic floor exercises after radical prostatectomy can aid in the recovery of urinary control; however, conventional pelvic floor exercises do not produce consistent results. Research indicates that incorporating other deep abdominal muscles can further activate the pelvic floor making it stronger than by activating the pelvic floor alone. Specifically, 'Pfilates' and 'Hypopressives' are two new techniques that combine traditional pelvic floor exercises with activation of supportive muscles. Our proposed study will be the first to test the effect of an advanced pelvic floor exercise training program that includes Pfilates and Hypopressives to treat urinary incontinence following radical prostatectomy. Our primary aim of this study is to assess the feasibility of conducting a full-scale RCT of an advanced pelvic floor exercise training program, including standard pelvic floor exercises, Pfilates, and Hypopressives techniques on urinary incontinence. Feasibility will be determined by measuring recruitment success, retention, outcome capture, and intervention adherence, tolerance, and safety. We hypothesize men under going radical prostatectomy for prostate cancer in the advance pelvic floor training program will report greater improvement in urinary incontinence and health-related quality of life.


Eligibility criteria: Inclusion Criteria:

* Men with localized prostate cancer (stage cT1-cT2) who have consented for radical prostatectomy (open retropubic, laparoscopic, robot-assisted laparoscopic)
* Between the the ages of 40 and 80 years
* Proficient in English

Exclusion Criteria:

* i) Diagnosed with a known neurological disease, autoimmune connective tissue disorder;
* ii) Have prior experience with pelvic floor training by a healthcare provider;
* iii) Have uncontrolled hypertension;
* iv) Have diagnosed COPD (Chronic Obstructive Pulmonary Disease) and/or chronic restrictive respiratory disease; or
* v) Have a history of inguinal herniation

Primary outcomes:
measure: Recruitment
timeFrame: When recruitment is complete (approximately 12 months after study initiation; October 2015)
measure: Adherence to intervention group
timeFrame: 26 weeks post-operatively
measure: Study retention
timeFrame: 26 weeks post-operative
measure: 24-hour Pad Test for Urinary Leakage
timeFrame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively
measure: Pelvic Floor Strength
timeFrame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26, weeks post-operatively
Secondary outcomes:
measure: Quality of Life
timeFrame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operative
measure: 3-Day Bladder Diary for Urinary Incontinence
timeFrame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
measure: Self-Reported Urinary Incontinence, Prostate Symptoms, and Erectile Function
timeFrame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
measure: Body Composition
timeFrame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
measure: Physical Activity
timeFrame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References:
citation: Santa Mina D, Au D, Alibhai SM, Jamnicky L, Faghani N, Hilton WJ, Stefanyk LE, Ritvo P, Jones J, Elterman D, Fleshner NE, Finelli A, Singal RK, Trachtenberg J, Matthew AG. A pilot randomized trial of conventional versus advanced pelvic floor exercises to treat urinary incontinence after radical prostatectomy: a study protocol. BMC Urol. 2015 Sep 16;15:94. doi: 10.1186/s12894-015-0088-4.