University of Alberta
Edmonton, Alberta, T6G 2G4, Canada
Location status: Recruiting
NCT Number: NCT06072911
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.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Edmonton, Alberta, T6G 2G4, Canada
Location status: Recruiting
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
Secondary objectives of this study
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
General exercises will be prescribed along with a specialized pelvic floor program
A general progressive resistance exercise program
Advice on increasing physical activity
Time frame: Final assessment at one year
The number of participants completing the study including all planned outcomes
Time frame: One year
Percentage of participants who are eligible and agree to participate
Time frame: Post-intervention: 12 weeks
Adherence to the intervention components
Time frame: 24 hours at two time points: immediate post surgery and 12 weeks
Mean: Individual's urine loss by measuring weight (grams) of an absorbent pad
Time frame: One-year
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
Time frame: One-year
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
Time frame: One-year
Quality of life measure: Items are scored 0-100 (percentage of total possible score): Higher scores equal better quality of life
Time frame: One year
11-item ordinal scale; Range 0-60; with higher scores indicating higher symptom burden
Time frame: One year
6 item ordinal scale: Range 0-60; Higher scores indicating higher self-efficacy
Time frame: 12 weeks
Dyanometer: mean in kgs
Time frame: 12-weeks
Sit-to-stand: mean number completed in 30 seconds
Time frame: 12 weeks
Shoulder Range of Motion: mean value in degrees
Time frame: 12-weeks
Sit and reach: mean value in cm
Time frame: 12-weeks
One-leg stance test: mean time in seconds
Time frame: 12-weeks
Six-minute walk test: mean distance in metres
Time frame: 12-weeks
Height and weight will be combined to calculate BMI: mean: weight in kilograms divided by height in metres squared
Time frame: 12-weeks
mmol/L (mean value)
Time frame: 12-weeks
mmol/L (mean value)
Time frame: 12-weeks
Cholesterol level: mg/dL (mean value)
Time frame: 12-weeks
Value in percentage (mean value)
Contact information is provided by the study sponsor or research team.
Chris Sellar
CONTACT
Margaret L McNeely
CONTACT
University of Alberta
Other
Continence, Sexual and Metabolic Health Programming to Promote Prostate Cancer Wellness for Life (CONTROL4LIFE)
Acronym: CONTROL4LIFE
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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