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.
Opting to undergo HoLEP procedure for the treatment of BPH
Estimated prostate size (>60 ml)
Have received permission to exercise from their primary care provider
Access to a computer/ smartphone and internet access to complete associated questionnaires and access online educational resource
None
Parallel
Comprehensive Prehabilitation Programming
BehavioralThis 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.
Feasibility through modified system usability scale as well as through recruitment rates, adherence rates, and retention rates.
Feasibility will be assessed through a feasibility questionnaire administered only to participants in the intervention group prior to surgery. This questionnaire is a modified version of a previously established system usability scale which consists of 10 questions assessing the feasibility of the program which participants will rate on a 1-5 Likert scale. Four additional yes/no questions regarding feasibility for further assessment. Feasibility will also be assessed based on recruitment (with a goal of 30% of patients approached based on previous studies), adherence to the exercise protocol (with a goal of 70% adherence based on previous studies), and retention through the full 12-weeks of the intervention (with a goal of 80% based on previous studies.
Safety assessed through side effects of prehabilitation programming and reporting of adverse events.
Safety will be assessed through a modified version of safety questionnaires used in previously reported exercise and counselling studies. This will consist of 8 questions (graded on a 0-10 Likert scale) assessing the side effects of exercise programming, 4 questions (graded on a 0-10 Likert scale) assessing the side effects of mental health supports, and a question assessing adverse events. Any adverse events would be reported and graded minor (Grade ≤1 - not requiring medical intervention) or serious (Grade ≥2 - requiring medical intervention) based on previously established National Health Institute criteria.
International Prostate Symptom Score (IPSS)
The IPSS is a 7 question screen for lower urinary tract symptoms with each question graded on a 0-5 Likert scale. Greater scores indicate more severe dysfunction with the following cutoffs: mild (0-7), moderate (8-19), or severe (20-35).
Michigan Incontinence Symptom Index (M-ISI)
The M-ISI is a 10 item assessment of urinary incontinence symptoms with questions 1-8 being the total severity and questions 9 and 10 being the bother subsection of the questionnaire. Each question is graded on a 0-4 Likert scale with greater scores indicating more severe incontinence.
Sexual Health Inventory for Men (SHIM)
The SHIM is a 5-item assessment of erectile dysfunction severity with each question scored on a 0-5 Likert scale and higher scores indicating better erectile function. The following score cutoffs are used to describe dysfunction: 1-7: Severe ED, 8-11: Moderate ED, 12-16: Mild to Moderate ED, 17-21: Mild ED, 22-25: Normal Function.
Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD)
The MSHQ-EjD is a 4-item assessment of ejaculatory dysfunction which is broken into a function score for the first 3 questions and a bother score for the last question. Each question is graded on a 0-5 Likert scale with higher scores indicating better ejaculatory function.
International Physical Activity Questionnaire Short Form (IPAQ-SS)
This is a 7-item measure which collects information regarding the minutes of physical activity performed per week across different domains including: walking, mild activity, moderate activity, and strenuous activity. While patients are participating in the prehabilitation program an item will also be added for participants to report their adherence to home pelvic floor strengthening exercises and the questionnaire will be modified for them to report their 3-week physical activity average rather than only for a single week. This measure assesses minutes of physical activity per week so the minimum value is 0 minutes and the maximum value is 10080 minutes with greater values representing more physical activity. Each minute also has a multiplier applied for the metabolic equivalent of the task (METs) in order to generate a weekly number of METs. Again higher numbers are associated with more physical activity.
Size of surgical specimen
Once pathology is available the weight of the prostate tissue resected in grams will be recorded.
Estimated pre-surgical prostate size
Prior to the procedure, imaging and cystoscopy notes will be reviewed to obtain an estimate of prostate size. In the case of conflicting sizes reported, the most recent size on imaging will be recorded.
Post-surgical catheterization
The number of days each patient was catheterized after their HoLEP procedure.
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