Advanced Pelvic Floor Training Program for Prostate Cancer Surgery

Prostate Cancer Patients Undergoing Radical Prostatectomy Clinical Trial

— AFPX  

Official title:

A Randomized Pilot Study of Conventional Versus Advanced Pelvic Floor Exercises to Treat Urinary Incontinence After Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233608
• Other study ID #: D2014-20
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 3, 2014
• Last updated: October 24, 2017
• Start date: January 2015
• Est. completion date: September 28, 2017

Study information

• Verified date: October 2017
• Source: University of Guelph-Humber
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 28, 2017
• Est. primary completion date: September 28, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer Patients Undergoing Radical Prostatectomy
• Prostatic Neoplasms
• Urinary Incontinence

Intervention

Behavioral:
• Advanced Pelvic Floor Muscle Exercise (APFX)

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Guelph-Humber	Princess Margaret Hospital, Canada, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	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.	When recruitment is complete (approximately 12 months after study initiation; October 2015)
Primary	Adherence to intervention group	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.	26 weeks post-operatively
Primary	Study retention	Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.	26 weeks post-operative
Primary	24-hour Pad Test for Urinary Leakage	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.	At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively
Primary	Pelvic Floor Strength	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.	At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26, weeks post-operatively
Secondary	Quality of Life	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).	At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operative
Secondary	3-Day Bladder Diary for Urinary Incontinence	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.	At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
Secondary	Self-Reported Urinary Incontinence, Prostate Symptoms, and Erectile Function	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).	At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
Secondary	Body Composition	Body composition will be assessed via bioelectrical impedance analysis, height, weight, waist and hip circumference, and body mass index.	At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
Secondary	Physical Activity	Physical activity level will be measured wight he 3-item Godin Leisure Time Exercise Questionnaire - Leisure Score Index (GLTEQ-LSI).	At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively