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Benign Prostatic HyperplasiaNCT07552961

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).

A study testing Comprehensive Prehabilitation Programming in people with Benign Prostatic Hyperplasia and Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms, run by University of Calgary at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Comprehensive Prehabilitation Programming
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
1 Jun 2026to 1 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site
  • Southern Alberta Institute of Urology

    Calgary, Alberta, T2V 1P9

    Mark Assmus, MD, MPH, FRCSC, 403-943-8900, info@prostatecancercentre.ca

    Mark Assmus, MD, MPH, FRCSC

Other trials in Canada

About this study

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

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.

Read more

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.

Being tested
Comprehensive Prehabilitation Programming
Keywords
Prehabilitation, Exercise Therapy, Holmium Laser Enucleation of the Prostate, Mental Health Support, Safety, Feasibility, Incontinence
Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive Prehabilitation ProgrammingBehavioural

    Also called Exercise therapy, Mental Health Supports, Educational Resources

    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 groups in NCT07552961
Study groupRoleWhat they receive
Standard of CareNo interventionParticipants 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 ProgrammingActive comparatorParticipants 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.
Receives: Behavioral: Comprehensive Prehabilitation Programming

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: 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)
  1. 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).

    Measured: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.

  2. 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.

    Measured: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.

  3. 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.

    Measured: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.

  4. 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.

    Measured: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.

  5. Euroquol 5-Dimension 5-Level (EQ-5D-5L)

    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.

    Measured: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.

  6. Novel Incontinence Questionnaire

    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.

    Measured: To be collected at baseline, pre-surgery, and 4-, 12-, 26- and 52-weeks post-surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07552961
Sponsor's protocol ID
University of Calgary
Status last verified
Apr 2026
First submitted
3 Apr 2026
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

    PubMed 18183564
  • Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.

    PubMed 22169081
  • Anderson D, Kumar D, Divya D, Zepeda JL, Razzak AN, Hasoon J, Viswanath O, Kaye AD, Urits I. Mental Health in Non-Oncologic Urology Patients. Health Psychol Res. 2022 Sep 23;10(3):38352. doi: 10.52965/001c.38352. eCollection 2022.

    PubMed 36168643
  • Lingzhi S, Zhang H, Luo Y. The Impact of Self-Management Abilities, Sleep Quality, and Anxiety on the Well-Being of Patients With Benign Prostatic Hyperplasia: A Cross-Sectional Analysis. J Patient Exp. 2025 May 7;12:23743735251341726. doi: 10.1177/23743735251341726. eCollection 2025.

    PubMed 40351737
  • Pietrzyk B, Olszanecka-Glinianowicz M, Owczarek A, Gabryelewicz T, Almgren-Rachtan A, Prajsner A, Chudek J. Depressive symptoms in patients diagnosed with benign prostatic hyperplasia. Int Urol Nephrol. 2015 Mar;47(3):431-40. doi: 10.1007/s11255-015-0920-5. Epub 2015 Feb 12.

    PubMed 25673555
  • Liu X, Ma K, Yang L, Peng Z, Song P, Liu Z, Zhou J, Yu Y, Dong Q. The relationship between depression and benign prostatic hyperplasia in middle-aged and elderly men in India: a large-scale population study. BMC Public Health. 2023 Nov 3;23(1):2152. doi: 10.1186/s12889-023-17027-2.

    PubMed 37924045
  • Koh JS, Ko HJ, Wang SM, Cho KJ, Kim JC, Lee SJ, Pae CU. The Relationship between Depression, Anxiety, Somatization, Personality and Symptoms of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia. Psychiatry Investig. 2015 Apr;12(2):268-73. doi: 10.4306/pi.2015.12.2.268. Epub 2014 Dec 12.

    PubMed 25866530
  • Sandhu JS, Bixler BR, Dahm P, Goueli R, Kirkby E, Stoffel JT, Wilt TJ. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline Amendment 2023. J Urol. 2024 Jan;211(1):11-19. doi: 10.1097/JU.0000000000003698. Epub 2023 Sep 14.

    PubMed 37706750
  • Assmus MA, Lee MS, Helon J, Krambeck AE. Improving communication of post-holmium laser enucleation of the prostate recovery using a surgeon-patient handout. Can Urol Assoc J. 2022 Nov;16(11):E533-E538. doi: 10.5489/cuaj.7911.

    PubMed 35704929
  • Piercy KL, Troiano RP, Ballard RM, Carlson SA, Fulton JE, Galuska DA, George SM, Olson RD. The Physical Activity Guidelines for Americans. JAMA. 2018 Nov 20;320(19):2020-2028. doi: 10.1001/jama.2018.14854.

    PubMed 30418471
  • Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.

    PubMed 20559064
  • Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, Byers T, Gansler T. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012 Jul-Aug;62(4):243-74. doi: 10.3322/caac.21142. Epub 2012 Apr 26.

    PubMed 22539238
  • Geraerts I, Van Poppel H, Devoogdt N, Joniau S, Van Cleynenbreugel B, De Groef A, Van Kampen M. Influence of preoperative and postoperative pelvic floor muscle training (PFMT) compared with postoperative PFMT on urinary incontinence after radical prostatectomy: a randomized controlled trial. Eur Urol. 2013 Nov;64(5):766-72. doi: 10.1016/j.eururo.2013.01.013. Epub 2013 Jan 21.

    PubMed 23357349
  • Dijkstra-Eshuis J, Van den Bos TW, Splinter R, Bevers RF, Zonneveld WC, Putter H, Pelger RC, Voorham-van der Zalm PJ. Effect of preoperative pelvic floor muscle therapy with biofeedback versus standard care on stress urinary incontinence and quality of life in men undergoing laparoscopic radical prostatectomy: a randomised control trial. Neurourol Urodyn. 2015 Feb;34(2):144-50. doi: 10.1002/nau.22523. Epub 2013 Nov 19.

    PubMed 24249542
  • Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.

    PubMed 22018588

Questions about this trial

What is this clinical trial studying?

A study testing Comprehensive Prehabilitation Programming in people with Benign Prostatic Hyperplasia and Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07552961, which also lists 54 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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