Prostate CancerCONTROL4LIFENCT06072911
Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer
A study testing Pelvic floor exercise program, General exercise and Physical Activity Counseling in people with Prostate Cancer and Incontinence, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Incontinence, Metabolic Disease
- What is being tested?
- Pelvic floor exercise program, General exercise and Physical Activity Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteCanada
- Study dates
- 27 Feb 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2G4
Margaret McNeely, 7802481531, mmcneely@ualberta.ca
About this study
Official title: Continence, Sexual and Metabolic Health Programming to Promote Prostate Cancer Wellness for Life (CONTROL4LIFE)
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.
Read the 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
- 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.
- Conditions
- Prostate Cancer, Incontinence, Metabolic Disease
- Being tested
- Pelvic floor exercise program, General exercise, Physical Activity Counseling
- Medical subject headings
- Prostatic Neoplasms, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor exercise programBehavioural
General exercises will be prescribed along with a specialized pelvic floor program
General exerciseBehavioural
A general progressive resistance exercise program
Physical Activity CounselingBehavioural
Advice on increasing physical activity
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Pelvic floor exercise program and general exercise programming Receives: Behavioral: Pelvic floor exercise program; Behavioral: General exercise |
| Control | Active comparator | Pelvic floor exercises and standard care (physical activity counseling) Receives: Behavioral: Pelvic floor exercise program; Behavioral: Physical Activity Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rate
The number of participants completing the study including all planned outcomes
Measured: Final assessment at one year
Secondary outcomes (19)
Recruitment rate
Percentage of participants who are eligible and agree to participate
Measured: One year
Adherence rate
Adherence to the intervention components
Measured: Post-intervention: 12 weeks
24-hour pad test
Mean: Individual's urine loss by measuring weight (grams) of an absorbent pad
Measured: 24 hours at two time points: immediate post surgery and 12 weeks
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
Measured: One-year
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
Measured: One-year
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
Measured: One-year
Edmonton Symptom Assessment Scale
11-item ordinal scale; Range 0-60; with higher scores indicating higher symptom burden
Measured: One year
Self-efficacy Questionnaire: Incontinence
6 item ordinal scale: Range 0-60; Higher scores indicating higher self-efficacy
Measured: One year
Grip Strength
Dyanometer: mean in kgs
Measured: 12 weeks
Lower body strength
Sit-to-stand: mean number completed in 30 seconds
Measured: 12-weeks
Upper limb mobility
Shoulder Range of Motion: mean value in degrees
Measured: 12 weeks
Flexibility
Sit and reach: mean value in cm
Measured: 12-weeks
Balance
One-leg stance test: mean time in seconds
Measured: 12-weeks
Walking endurance
Six-minute walk test: mean distance in metres
Measured: 12-weeks
Body Mass Index
Height and weight will be combined to calculate BMI: mean: weight in kilograms divided by height in metres squared
Measured: 12-weeks
Glucose
mmol/L (mean value)
Measured: 12-weeks
Insulin level
mmol/L (mean value)
Measured: 12-weeks
Lipid profile
Cholesterol level: mg/dL (mean value)
Measured: 12-weeks
Hemoglobin A1c
Value in percentage (mean value)
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start27 Feb 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Zelen design with randomization
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan Hoy, MD, Principal investigator, University of AlbertaHoward Evans, MD, Principal investigator, University of AlbertaMargaret McNeely, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072911
- Sponsor's protocol ID
- HREBA.CC-23-0207
- Acronym
- CONTROL4LIFE
- Status last verified
- Aug 2026
- First submitted
- 12 Sep 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be housed on the University of Alberta\'s Dataverse
Publications
Bernard S, Evans H, Hoy NY, Suderman K, Cameron B, Sexsmith J, Kinnaird A, Rourke K, Dean L, Pituskin E, Usmani N, Tandon P, McNeely ML. Control4Life: A randomized controlled trial protocol examining the feasibility and efficacy of a combined pelvic health rehabilitation and exercise fitness program for individuals undergoing prostatectomy. Contemp Clin Trials. 2024 Apr;139:107482. doi: 10.1016/j.cct.2024.107482. Epub 2024 Feb 29.
PubMed 38431130
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continence, Sexual and Metabolic Health Programming to Promote Prostate Cancer Wellness for Life (CONTROL4LIFE)
- ClinicalTrials.gov ID
- NCT06072911
- Acronym / sponsor ID
- CONTROL4LIFE / HREBA.CC-23-0207
- Conditions
- Prostate Cancer, Incontinence, Metabolic Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Zelen design with randomization
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Pelvic floor exercise program, Behavioral: General exercisePelvic floor exercise program and general exercise programming |
| Control | Active comparator | Behavioral: Pelvic floor exercise program, Behavioral: Physical Activity CounselingPelvic floor exercises and standard care (physical activity counseling) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor exercise programGeneral exercises will be prescribed along with a specialized pelvic floor program | Behavioural | Control, Intervention |
| General exerciseA general progressive resistance exercise program | Behavioural | Intervention |
| Physical Activity CounselingAdvice on increasing physical activity | Behavioural | Control |
Primary outcome
Completion Rate
Time frame: Final assessment at one year
The number of participants completing the study including all planned outcomes
19 secondary outcomes
Recruitment rate
Time frame: One year
Adherence rate
Time frame: Post-intervention: 12 weeks
24-hour pad test
Time frame: 24 hours at two time points: immediate post surgery and 12 weeks
Expanded Prostate Cancer Index Composite for Clinical Practice
Time frame: One-year
International Consultation on Incontinence Questionnaire
Time frame: One-year
36-Item Short Form Survey
Time frame: One-year
Edmonton Symptom Assessment Scale
Time frame: One year
Self-efficacy Questionnaire: Incontinence
Time frame: One year
Grip Strength
Time frame: 12 weeks
Lower body strength
Time frame: 12-weeks
Upper limb mobility
Time frame: 12 weeks
Flexibility
Time frame: 12-weeks
Balance
Time frame: 12-weeks
Walking endurance
Time frame: 12-weeks
Body Mass Index
Time frame: 12-weeks
Glucose
Time frame: 12-weeks
Insulin level
Time frame: 12-weeks
Lipid profile
Time frame: 12-weeks
Hemoglobin A1c
Time frame: 12-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Derived from this study: PubMed 38431130Bernard S, Evans H, Hoy NY, Suderman K, Cameron B, Sexsmith J, Kinnaird A, Rourke K, Dean L, Pituskin E, Usmani N, Tandon P, McNeely ML. Control4Life: A randomized controlled trial protocol examining the feasibility and efficacy of a combined pelvic health rehabilitation and exercise fitness program for individuals undergoing prostatectomy. Contemp Clin Trials. 2024 Apr;139:107482. doi: 10.1016/j.cct.2024.107482. Epub 2024 Feb 29.
- Individual participant dataSharing planned: Yes. Data will be housed on the University of Alberta\'s Dataverse
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan Hoy, MD principal investigator
University of Alberta
Howard Evans, MD principal investigator
University of Alberta
Margaret McNeely principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor exercise program, General exercise and Physical Activity Counseling in people with Prostate Cancer and Incontinence, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaret L McNeely (780-492-6007, mmcneely@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rate (time frame: Final assessment at one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06072911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.