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).

Evaluating the Feasibility of a Comprehensive Prehabilitation Program for Use in Benign Prostatic Hyperplasia Patients Undergoing Holmium Laser Enucleation of the Prostate

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07552961

Enrollment

Registered

2026-04-27

Start date

2026-06-01

Completion date

2027-11-01

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

BEHAVIORALComprehensive Prehabilitation Programming

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 design

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

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Opting to undergo HoLEP procedure for the treatment of BPH 2. Estimated prostate size (\>60 ml) 3. Have received permission to exercise from their primary care provider 4. 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

Design outcomes

Primary

Measure	Time frame	Description
Feasibility through modified system usability scale as well as through recruitment rates, adherence rates, and retention rates.	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.	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

Measure	Time frame	Description
International Prostate Symptom Score (IPSS)	To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.	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)	To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.	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)	To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.	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)	To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.	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.
Euroquol 5-Dimension 5-Level (EQ-5D-5L)	To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.	The EQ-5D-5L is a 6-item assessment of quality of life. The first 5 items are graded on a 1-5 Likert scale with higher scores indicating worse quality of life. The last item is a 0-100 rating of overall health status with higher scores indicating better health.
Novel Incontinence Questionnaire	To be collected at baseline, pre-surgery, and 4-, 12-, 26- and 52-weeks post-surgery.	This is a questionnaire the investigators designed with yes/no questions to assess whether patients are experiencing any incontinence. Pre-surgery, the questionnaire is divided based on catheterization status - if a participant has a catheter it asks whether they had incontinence prior to catheterization and if a participant does not have a catheter it asks whether they currently have incontinence. Post-surgery, the questionnaire assesses whether the participant still has incontinence and if they report they do not, asks which week after surgery they stopped experiencing incontinence.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026