Advanced Pelvic Floor Training Program for Prostate Cancer Surgery (AFPX)
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|ClinicalTrials.gov Identifier: NCT02233608|
Recruitment Status : Completed
First Posted : September 8, 2014
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Patients Undergoing Radical Prostatectomy||Behavioral: Advanced Pelvic Floor Muscle Exercise (APFX)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Pilot Study of Conventional Versus Advanced Pelvic Floor Exercises to Treat Urinary Incontinence After Radical Prostatectomy|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||September 28, 2017|
|Actual Study Completion Date :||September 28, 2017|
No Intervention: 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).
Experimental: 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.
Behavioral: Advanced Pelvic Floor Muscle Exercise (APFX)
- 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.
- Quality of Life [ Time Frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operative ]Prostate specific quality of life will be measured using the Functional Assessment of Cancer Treatment-Prostate (FACT-P) and the Patient-Oriented Prostate Utility Scale (PORPUS).
- 3-Day Bladder Diary for Urinary Incontinence [ Time Frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively ]The bladder diary is a standard instrument for self-reporting voiding patterns. Items include fluid intake, frequency of toilet voids, episode of urine loss, number of pads used, and activity during event for the three-day period. Bladder diaries are widely used in clinical trials assessing urinary incontinence after radical prostatectomy.
- Self-Reported Urinary Incontinence, Prostate Symptoms, and Erectile Function [ Time Frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively ]Urological symptoms are assessed using the International Prostate Symptom Score (IPSS). Additional, a single item regarding leaking urine and bladder control from the PORPUS will be used to evaluate incontinence. Erectile function will be assessed using the 5-item International Index of Erectile Function scale (5-IIEF).
- Body Composition [ Time Frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively ]Body composition will be assessed via bioelectrical impedance analysis, height, weight, waist and hip circumference, and body mass index.
- Physical Activity [ Time Frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively ]Physical activity level will be measured wight he 3-item Godin Leisure Time Exercise Questionnaire - Leisure Score Index (GLTEQ-LSI).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233608
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|