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

Prostate Cancer Clinical Trial

— CONTROL4LIFE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06072911
• Other study ID #: HREBA.CC-23-0207
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: University of Alberta
• Contact: Margaret L McNeely
• Phone: 780-492-6007
• Email: mmcneely[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• have a diagnosis of prostate cancer (stage I to IV);
• be scheduled for a prostatectomy surgery (any surgical approach);
• have no restriction to participate in at least mild levels of physical activity, as confirmed by the Physical Activity Readiness Questionnaire (PAR-Q+);
• speak and understand English.
• adult: 18 years of age or older
• optional exercise component: willing and able to commit to the 12-week intervention

Exclusion Criteria:

• have any medical conditions that may interfere with continence (i.e. neurological diseases);
• have any contraindications to exercise testing or training;
• have recent (>6 months) modifications to any medication aiming to reduce urinary incontinence (i.e. Myrbetric);
• do not have regular access to the internet and a smart device or a computer at home/ at their community center;
• are already receiving a pelvic floor exercise program through a pelvic floor physical therapist from their community.

Related Conditions & MeSH terms

• Incontinence
• Metabolic Disease
• Metabolic Diseases
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Pelvic floor exercise program
General exercises will be prescribed along with a specialized pelvic floor program
• General exercise
A general progressive resistance exercise program
• Physical Activity Counseling
Advice on increasing physical activity

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion Rate	The number of participants completing the study including all planned outcomes	Final assessment at one year
Secondary	Recruitment rate	Percentage of participants who are eligible and agree to participate	One year
Secondary	Adherence rate	Adherence to the intervention components	Post-intervention: 12 weeks
Secondary	24-hour pad test	Mean: Individual's urine loss by measuring weight (grams) of an absorbent pad	24 hours at two time points: immediate post surgery and 12 weeks
Secondary	Expanded Prostate Cancer Index Composite for Clinical Practice	16-questions: urinary function, sexual and erectile function, bowel and hormonal function; Scores: 0 (no symptoms) to 60 (most severe symptoms); Higher scores indicate worse functioning	One-year
Secondary	International Consultation on Incontinence Questionnaire	13 questions: occurrence and bother of lower urinary tract symptoms, quality of life; Range of scores: 0-20 voiding subscale; 0-20 incontinence symptoms; Higher scores indicate worse functioning	One-year
Secondary	36-Item Short Form Survey	Quality of life measure: Items are scored 0-100 (percentage of total possible score): Higher scores equal better quality of life	One-year
Secondary	Edmonton Symptom Assessment Scale	11-item ordinal scale; Range 0-60; with higher scores indicating higher symptom burden	One year
Secondary	Self-efficacy Questionnaire: Incontinence	6 item ordinal scale: Range 0-60; Higher scores indicating higher self-efficacy	One year
Secondary	Grip Strength	Dyanometer: mean in kgs	12 weeks
Secondary	Lower body strength	Sit-to-stand: mean number completed in 30 seconds	12-weeks
Secondary	Upper limb mobility	Shoulder Range of Motion: mean value in degrees	12 weeks
Secondary	Flexibility	Sit and reach: mean value in cm	12-weeks
Secondary	Balance	One-leg stance test: mean time in seconds	12-weeks
Secondary	Walking endurance	Six-minute walk test: mean distance in metres	12-weeks
Secondary	Body Mass Index	Height and weight will be combined to calculate BMI: mean: weight in kilograms divided by height in metres squared	12-weeks
Secondary	Glucose	mmol/L (mean value)	12-weeks
Secondary	Insulin level	mmol/L (mean value)	12-weeks
Secondary	Lipid profile	Cholesterol level: mg/dL (mean value)	12-weeks
Secondary	Hemoglobin A1c	Value in percentage (mean value)	12-weeks