Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer (CONTROL4LIFE)

University of Alberta

Status: Enrolling

Conditions: Metabolic Disease; Prostate Cancer; Incontinence

Treatments: Behavioral: General exercise; Behavioral: Physical Activity Counseling; Behavioral: Pelvic floor exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT06072911

HREBA.CC-23-0207

Details and patient eligibility

About

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.

Full 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

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.

Enrollment: 106 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

106 participants in 2 patient groups

Intervention

Experimental group

Description:

Pelvic floor exercise program and general exercise programming

Treatment:

Behavioral: Pelvic floor exercise program

Behavioral: General exercise

Control

Active Comparator group

Description:

Pelvic floor exercises and standard care (physical activity counseling)

Treatment:

Behavioral: Pelvic floor exercise program

Behavioral: Physical Activity Counseling