A Randomized Pilot Study of Conventional Versus Advanced Pelvic Floor Exercises to Treat Urinary Incontinence After Radical Prostatectomy
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Guelph-Humber
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Recruitment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Usual Care
The usual care group will receive generic pelvic floor muscle exercise (PMFX) instructions and demonstrations by the research coordinator at the initial post-operative time point. This will include instruction on how to engage the pelvic floor and specific PFMX prescription. Repetition volume will start at 20 repetitions per day during weeks 1-2; 60/day during weeks 3-4; and 90/day during weeks 5-6, and 100+/day for weeks 7-26. The total number of repetitions will be divided equally between rhythmic (contract and relaxed over one second) and sustained contractions (contract and hold for up to 10 seconds).
Advanced Pelvic Floor Exercise (APFX)
Participants in this group will receive detailed week-by-week description of the program. The program progresses participants through stages of training every two weeks, starting the introduction of basic PFMX, and slowly incorporates Pfilates and Hypopressives exercises until week 8, where patients will maintain the final stage of training until week 26 or urinary incontinence is completely resolved.
Intervention: Advanced Pelvic Floor Muscle Exercise (APFX) (Behavioral)
Outcomes
Primary Outcomes
Recruitment
Time Frame: When recruitment is complete (approximately 12 months after study initiation; October 2015)
Prior pelvic floor training trials in prostate cancer patients undergoing radical prostatectomy have observed recruitment rates of 21-70%. We will measure recruitment success through participant recruitment per week and record reasons for non-participation from those who inquire about the study and are eligible to participate but refuse.
Adherence to intervention group
Time Frame: 26 weeks post-operatively
Adherence to the two groups (standard pelvic floor exercises and advanced pelvic floor exercises) will be measured through a logbook that is included in their respective program manuals as well as a logbook completed by the research coordinator during the weekly telephone communications.
Study retention
Time Frame: 26 weeks post-operative
Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.
24-hour Pad Test for Urinary Leakage
Time Frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively
A 24-hour pad test will be used to measure urinary incontinence by assessing the quantity of urine lost in one day. A urinary leakage pad is measured after a 24-hour period and compared to the unused pad weight and is used to most accurately assess the severity of urinary incontinence.
Pelvic Floor Strength
Time Frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26, weeks post-operatively
Digital rectal examination of pelvic floor strength by a specially trained pelvic floor physiotherapist will be conducted. Pelvic floor strength will be graded on the Modified Oxford Scale.
Secondary Outcomes
- Quality of Life(At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operative)
- 3-Day Bladder Diary for Urinary Incontinence(At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively)
- Self-Reported Urinary Incontinence, Prostate Symptoms, and Erectile Function(At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively)
- Body Composition(At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively)
- Physical Activity(At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively)
Investigators
Daniel Santa Mina
Scientist
University Health Network, Toronto