Prehabilitation Program for Enlarged Prostate

Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Benign prostatic hyperplasia (BPH) is a debilitating condition which is highly prevalent in older males, up to 45% of those over the age of 45 are affected and 80% of those over the age of 70 are affected. While not all men with BPH experience problematic symptoms, many will experience lower urinary tract symptoms (LUTS) including difficulty passing urine, recurrent urinary tract infections, bladder stones, and hematuria. Holmium Laser Enucleation of the Prostate (HoLEP) is the gold standard in terms of surgical BPH management and is associated with a low risk for requiring repeat interventions. However, in the weeks following HoLEP procedures many men will experience transient urinary incontinence which can be distressing to patients.

In the setting of prostate cancer, exercise and mental health supports prior to surgery has been shown to improve incontinence and post-surgical recovery. This is often termed prehabilitation and consists of programming done in the months before surgery. The objective of this study is to assess the safety and feasibility of prehabilitation programming prior to HoLEP procedures for men with BPH.

The investigators will be randomizing 40 patients into 2 groups, one receiving standard of care interventions prior to their HoLEP surgery and one receiving at least 12 weeks of comprehensive prehabilitation programming including: pelvic floor physiotherapy, access to additional informational resources, and access to mental health supports including individual and couples counselling. In both groups the investigators will be collecting key demographics and clinical information from patients as well as assessing their urinary function through several questionnaires before prehabilitation, immediately before surgery, and up to 1 year after surgery.

The investigators hope to establish that prehabilitation is a safe and feasible option for these patients. Secondarily investigators hope to provide evidence that prehabilitation improves incontinence faster following HoLEP procedures and improves post-surgical recovery.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have chosen to have HoLEP surgery for my enlarged prostate.
My prostate is estimated to be larger than 60 ml.
3. Have received permission to exercise from their primary care provider
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a comprehensive prehabilitation program including pelvic floor physiotherapy, informational resources, and mental health supports for at least 12 weeks

12 weeks
Every 3 weeks (in-person or virtual)

Surgery

Participants undergo Holmium Laser Enucleation of the Prostate (HoLEP)

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, with assessments at multiple time points

52 weeks
4-, 12-, 26-, and 52-weeks post-surgery (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Comprehensive Prehabilitation Programming

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Standard of CareActive Control1 Intervention
Group II: Comprehensive Prehabilitation ProgrammingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+