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Completed

NCT Number: NCT02233608

Advanced Pelvic Floor Training Program for Prostate Cancer Surgery

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.

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Key information

Conditions

Prostate Cancer Patients Undergoing Radical Prostatectomy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urological Manifestations

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advanced Pelvic Floor Muscle Exercise (APFX)

Behavioral

Primary outcomes

  1. 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.

  2. 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.

  3. Study retention

    Time frame: 26 weeks post-operative

    Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.

  4. 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.

  5. 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

  1. 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).

  2. 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.

  3. 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).

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

University of Guelph-Humber

Other

Collaborators

  • Princess Margaret Hospital, Canada
  • University Health Network, Toronto

Registry information

Official study title

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

Acronym: AFPX

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 8, 2014
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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