Evaluating the Feasibility of a Comprehensive Prehabilitation Program for Use in Benign Prostatic Hyperplasia Patients Undergoing Holmium Laser Enucleation of the Prostate
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Calgary
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Feasibility through modified system usability scale as well as through recruitment rates, adherence rates, and retention rates.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Masking Description
For data analysis the investigators plan to randomize participant information while maintaining grouping in order to blind the analyst.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •1\. Other medical or psychiatric conditions which preclude the ability to participate in exercise or utilize the online education module
Arms & Interventions
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.
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.
Intervention: Comprehensive Prehabilitation Programming (Behavioral)
Outcomes
Primary Outcomes
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.
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.
Time Frame: To be administered every 3 weeks of the 12-week prehabilitation program starting with the 3rd week and ending with the 12th week.
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.
Secondary Outcomes
- International Prostate Symptom Score (IPSS)(To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.)
- Michigan Incontinence Symptom Index (M-ISI)(To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.)
- Sexual Health Inventory for Men (SHIM)(To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.)
- Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD)(To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.)
- Euroquol 5-Dimension 5-Level (EQ-5D-5L)(To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.)
- Novel Incontinence Questionnaire(To be collected at baseline, pre-surgery, and 4-, 12-, 26- and 52-weeks post-surgery.)
Investigators
Mark Assmus
Associate Professor
University of Calgary