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NCT Number: NCT06072911

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

Location status: Recruiting

Location contact

Margaret McNeely

CONTACT

[email protected]

7802481531

About this study

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

  • 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.
  • Determine the effects of the program on the primary outcome measure of urinary continence in comparison with usual care.

Secondary objectives of this study

  • To determine the effects of the program on cardiometabolic indicators in comparison with usual care.
  • 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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Pelvic floor exercise program

Behavioral

General exercises will be prescribed along with a specialized pelvic floor program

General exercise

Behavioral

A general progressive resistance exercise program

Physical activity counseling

Behavioral

Advice on increasing physical activity

Primary outcomes

  1. Completion Rate

    Time frame: Final assessment at one year

    The number of participants completing the study including all planned outcomes

Secondary outcomes

  1. Recruitment rate

    Time frame: One year

    Percentage of participants who are eligible and agree to participate

  2. Adherence rate

    Time frame: Post-intervention: 12 weeks

    Adherence to the intervention components

  3. 24-hour pad test

    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

  4. Expanded Prostate Cancer Index Composite for Clinical Practice

    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

  5. International Consultation on Incontinence Questionnaire

    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

  6. 36-Item Short Form Survey

    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

  7. Edmonton Symptom Assessment Scale

    Time frame: One year

    11-item ordinal scale; Range 0-60; with higher scores indicating higher symptom burden

  8. Self-efficacy Questionnaire: Incontinence

    Time frame: One year

    6 item ordinal scale: Range 0-60; Higher scores indicating higher self-efficacy

  9. Grip Strength

    Time frame: 12 weeks

    Dyanometer: mean in kgs

  10. Lower body strength

    Time frame: 12-weeks

    Sit-to-stand: mean number completed in 30 seconds

  11. Upper limb mobility

    Time frame: 12 weeks

    Shoulder Range of Motion: mean value in degrees

  12. Flexibility

    Time frame: 12-weeks

    Sit and reach: mean value in cm

  13. Balance

    Time frame: 12-weeks

    One-leg stance test: mean time in seconds

  14. Walking endurance

    Time frame: 12-weeks

    Six-minute walk test: mean distance in metres

  15. Body Mass Index

    Time frame: 12-weeks

    Height and weight will be combined to calculate BMI: mean: weight in kilograms divided by height in metres squared

  16. Glucose

    Time frame: 12-weeks

    mmol/L (mean value)

  17. Insulin level

    Time frame: 12-weeks

    mmol/L (mean value)

  18. Lipid profile

    Time frame: 12-weeks

    Cholesterol level: mg/dL (mean value)

  19. Hemoglobin A1c

    Time frame: 12-weeks

    Value in percentage (mean value)

Study contacts

Contact information is provided by the study sponsor or research team.

Chris Sellar

CONTACT

[email protected]

780-492-6007

Margaret L McNeely

CONTACT

[email protected]

780-492-6007

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Acronym: CONTROL4LIFE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
May 29, 2026

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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