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

NCT06072911 | Recruiting

• 1 other identifier: HREBA.CC-23-0207
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Incontinence; Metabolic Disease; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Completion Rate

  The number of participants completing the study including all planned outcomes

  Final assessment at one year

Secondary Outcomes (19)

• Recruitment rate

  One year

• Adherence rate

  Post-intervention: 12 weeks

• 24-hour pad test

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

• Expanded Prostate Cancer Index Composite for Clinical Practice

  One-year

• International Consultation on Incontinence Questionnaire

  One-year

Study Arms (2)

Intervention

EXPERIMENTAL

Pelvic floor exercise program and general exercise programming

Behavioral: Pelvic floor exercise program; Behavioral: General exercise

Control

ACTIVE COMPARATOR

Pelvic floor exercises and standard care (physical activity counseling)

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

Interventions

Pelvic floor exercise program BEHAVIORAL

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

Control; Intervention

General exercise BEHAVIORAL

A general progressive resistance exercise program

Intervention

Physical Activity Counseling BEHAVIORAL

Advice on increasing physical activity

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 38431130 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Metabolic Diseases

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nathan Hoy, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Howard Evans, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Margaret McNeely

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret L McNeely

CONTACT

780-492-6007; mmcneely@ualberta.ca

Chris Sellar

CONTACT

780-492-6007; frmace@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants will be randomized after the baseline assessment and will have the option to take part in an additional exercise intervention component.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Zelen design with randomization

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: October 10, 2023
• Study Start: February 27, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following completion of the study and primary publication.

Locations

CA (1)