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).

NCT07552961 | Not Yet Recruiting

• 1 other identifier: University of Calgary
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Prehabilitation; Exercise Therapy; Holmium Laser Enucleation of the Prostate; Mental Health Support; Safety; Feasibility; Incontinence

Outcome Measures

Primary Outcomes (2)

• 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.

  Only assessed at the pre-surgical follow-up (ie. from baseline to pre-surgery), between 1-4 weeks prior to surgery.

• 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.

  To be administered every 3 weeks of the 12-week prehabilitation program starting with the 3rd week and ending with the 12th week.

Secondary Outcomes (6)

• 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.

Other Outcomes (9)

• International Physical Activity Questionnaire Short Form (IPAQ-SS)

  To be collected at baseline, every 3 weeks during the 12-week prehabilitation program (starting at week 3 and ending at week 12), and at 4-, 12-, and 26-weeks post-surgery.

• Size of surgical specimen

  Peri-operative period, up to 8 weeks after surgery pending results of surgical pathology.

• Estimated pre-surgical prostate size

  Peri-operative period, up to 8 weeks after surgery pending results of surgical pathology.

Study Arms (2)

Standard of Care

NO INTERVENTION

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

ACTIVE COMPARATOR

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.

Behavioral: Comprehensive Prehabilitation Programming

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.

Also known as: Exercise therapy, Mental Health Supports, Educational Resources

Comprehensive Prehabilitation Programming

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• \. Other medical or psychiatric conditions which preclude the ability to participate in exercise or utilize the online education module

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Southern Alberta Institute of Urology

Calgary, Alberta, T2V 1P9, Canada

Location

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MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: For data analysis the investigators plan to randomize participant information while maintaining grouping in order to blind the analyst.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 27, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CA (1)