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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-27

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer Incontinence Metabolic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Zelen design with randomization

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The participants will be randomized after the baseline assessment and will have the option to take part in an additional exercise intervention component.

Study Groups

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Intervention

Pelvic floor exercise program and general exercise programming

Group Type EXPERIMENTAL

Pelvic floor exercise program

Intervention Type BEHAVIORAL

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

General exercise

Intervention Type BEHAVIORAL

A general progressive resistance exercise program

Control

Pelvic floor exercises and standard care (physical activity counseling)

Group Type ACTIVE_COMPARATOR

Pelvic floor exercise program

Intervention Type BEHAVIORAL

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

Physical Activity Counseling

Intervention Type BEHAVIORAL

Advice on increasing physical activity

Interventions

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Pelvic floor exercise program

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

Intervention Type BEHAVIORAL

General exercise

A general progressive resistance exercise program

Intervention Type BEHAVIORAL

Physical Activity Counseling

Advice on increasing physical activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No