Health TrialsbyHealthPanel

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

ConditionsProstate CancerIncontinenceMetabolic Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 2 interventions
Group B: ControlActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Completion Rate

The number of participants completing the study including all planned outcomes

Time frame
Final assessment at one year

Secondary outcomes

1

Recruitment rate

Percentage of participants who are eligible and agree to participate

Time frame
One year
2

Adherence rate

Adherence to the intervention components

Time frame
Post-intervention: 12 weeks
3

24-hour pad test

Mean: Individual's urine loss by measuring weight (grams) of an absorbent pad

Time frame
24 hours at two time points: immediate post surgery and 12 weeks
4

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

Time frame
One-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov
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