Feasibility and Utility of a Prehabilitation Program for Use in Patients With Benign Prostatic Hyperplasia Who Have Elected to Undergo Holmium Laser Enucleation of the Prostate (HoLEP).

Sponsor
University of Calgary
Study ID
NCT07552961
Status
Not Yet Recruiting

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Conditions

  • Benign Prostatic Hyperplasia
  • Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
  • Benign Prostatic Hyperplasia With Outflow Obstruction

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Comprehensive Prehabilitation Programming — BEHAVIORAL
    This prehabilitation program will include an exercise component consisting of once weekly pelvic floor physiotherapy sessions as well as recommendations to complete pelvic floor strengthening exercises and 150 minutes of moderate to intense cardiovascular exercise at home. Completion of these exercises will be self-reported biweekly through an exercise tracking form submitted to study staff. This program will also include access to a comprehensive online module with information about BPH and the HoLEP procedure. Lastly, this will consist of access to mental health supports including individual and couples counselling.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • No Intervention: Standard of Care
    Participants in this arm will receive standard information and recommendations from a surgeon prior to HoLEP. These include recommendations to participate in exercise and information about what to expect with the procedure.
  • Active Comparator: Comprehensive Prehabilitation Programming
    Participants in this arm will receive the standard of care recommendations from a urologist but will also complete a comprehensive prehabilitation program over 12-weeks within 5 months of the procedure.

Primary Outcome Measure

Feasibility through modified system usability scale as well as through recruitment rates, adherence rates, and retention rates. [ Time Frame: Only assessed at the pre-surgical follow-up (ie. from baseline to pre-surgery), between 1-4 weeks prior to surgery. ]

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