Advanced Pelvic Floor Training Program for Prostate Cancer Surgery

NCT ID: NCT02233608

Last Updated: 2017-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-09-28

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.

Conditions

Prostate Cancer Patients Undergoing Radical Prostatectomy

Keywords

Prostate cancer; Radical prostatectomy; Pelvic floor muscle exercises; Pfilates; Hypopressives; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Advanced Pelvic Floor Muscle Exercise (APFX)

Intervention Type: BEHAVIORAL

Interventions

Advanced Pelvic Floor Muscle Exercise (APFX)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

University of Guelph-Humber

OTHER

Sponsor Role: lead

Responsible Party

Daniel Santa Mina

Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

References

Santa Mina D, Au D, Alibhai SM, Jamnicky L, Faghani N, Hilton WJ, Stefanyk LE, Ritvo P, Jones J, Elterman D, Fleshner NE, Finelli A, Singal RK, Trachtenberg J, Matthew AG. A pilot randomized trial of conventional versus advanced pelvic floor exercises to treat urinary incontinence after radical prostatectomy: a study protocol. BMC Urol. 2015 Sep 16;15:94. doi: 10.1186/s12894-015-0088-4.

Reference Type: DERIVED

PMID: 26377550 (View on PubMed)

Other Identifiers

D2014-20

Identifier Type: -

Identifier Source: org_study_id