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).

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Comprehensive 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

Первичные конечные точки

• Feasibility through modified system usability scale as well as through recruitment rates, adherence rates, and retention rates. [Срок оценки: 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. [Срок оценки: To be administered every 3 weeks of the 12-week prehabilitation program starting with the 3rd week and ending with the 12th week.]

Вторичные конечные точки (6)

• International Prostate Symptom Score (IPSS) [Срок оценки: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.]
• Michigan Incontinence Symptom Index (M-ISI) [Срок оценки: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.]
• Sexual Health Inventory for Men (SHIM) [Срок оценки: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.]
• Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD) [Срок оценки: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.]
• Euroquol 5-Dimension 5-Level (EQ-5D-5L) [Срок оценки: To be collected at baseline, pre-surgery, and 4-, 12-, 26-, and 52-weeks post-surgery.]
• Novel Incontinence Questionnaire [Срок оценки: To be collected at baseline, pre-surgery, and 4-, 12-, 26- and 52-weeks post-surgery.]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Канада · 1 центр

• Southern Alberta Institute of Urology — Calgary

Публикации

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• 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. PMID 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. PMID 40351737
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• 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. PMID 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. PMID 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. PMID 37706750

Идентификаторы

NCT: NCT07552961 · University of Calgary

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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