Prostate Cancer Patients Undergoing Radical Prostatectomy
Conditions
Keywords
Prostate cancer, Radical prostatectomy, Pelvic floor muscle exercises, Pfilates, Hypopressives, Urinary Incontinence
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.
Interventions
BEHAVIORALAdvanced Pelvic Floor Muscle Exercise (APFX)
Sponsors
Princess Margaret Hospital, Canada
University Health Network, Toronto
University of Guelph-Humber
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Strength | 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. |
| Recruitment | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 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 | 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 | 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 | 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 | 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). |
Countries
Canada
Outcome results
None listed