NCT06072911

Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer

Continence, Sexual and Metabolic Health Programming to Promote Prostate Cancer Wellness for Life (CONTROL4LIFE)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Continence, Sexual and Metabolic Health (CONTROL 4 LIFE) study will evaluate the recovery of continence, sexual function, and health outcomes in individuals who have undergone surgery for prostate cancer. The purpose of this study is to better understand the timelines of recovery for these outcomes after surgery for prostate cancer. As part of this study, all participants will receive resources offered by Alberta Health Services regarding pre- and post-prostatectomy care, including information on pelvic floor exercises. Through the CONTROL 4 LIFE study, the investigators will also be evaluating outcomes related to physical activity, fitness and quality of life. These assessments will enable the investigators to better understand how well and how long it takes for individuals to recover after surgery for prostate cancer.

Detailed description

The investigators aim to conduct a trial examining the feasibility and the effects of a combined pelvic health rehabilitation and exercise program that can be delivered both in-person and virtually in individuals who have been treated with prostatectomy for prostate cancer. This hybrid format will support equitable program delivery regardless of location of residence. To address issues faced by men with prostate cancer, the investigators propose an intervention (offered virtually and in-person) that includes: 1) online education to support continence, sexual and overall health; 2) a group exercise fitness program that considers the needs and restrictions specific to the early post-prostatectomy surgical period, and 3) functional and intensive pelvic floor muscle exercise retraining to promote continence and sexual recovery. Main objectives of this study 1. Determine the feasibility, defined as the acceptability and appropriateness, of a combined pelvic health rehabilitation and exercise fitness program that can be delivered both in-person and virtually. 2. Determine the effects of the program on the primary outcome measure of urinary continence in comparison with usual care. Secondary objectives of this study 1. To determine the effects of the program on cardiometabolic indicators in comparison with usual care. 2. To determine the effects of the program on general fitness, secondary outcomes of urinary continence, sexual function, self-efficacy, and cancer symptom burden, in comparison with usual care.

Conditions

• Prostate Cancer
• Incontinence
• Metabolic Disease

Interventions

Type	Name	Description
BEHAVIORAL	Pelvic floor exercise program	General exercises will be prescribed along with a specialized pelvic floor program
BEHAVIORAL	General exercise	A general progressive resistance exercise program
BEHAVIORAL	Physical Activity Counseling	Advice on increasing physical activity

Timeline

• Start date: 2024-02-27
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2023-10-10
• Last updated: 2026-01-30

Locations

1 site across 1 country: Canada