Effect of Group Preoperative Pelvic Floor Training for HoLEP

Официальное название

The Effect of Group Preoperative Pelvic Floor Training on Transient Urinary Incontinence After Holmium Laser Enucleation of the Prostate: A Prospective Cohort Study

Обзор

The main goal of this study is to see if group pelvic floor training before surgery can help prevent urinary incontinence after Holmium laser enucleation of the prostate (HoLEP) surgery. The study has the potential to inform preoperative intervention strategies for managing incontinence after HoLEP.

Подробное описание

Preoperative pelvic floor training (PFT) may improve early urinary incontinence after prostate surgery. Group-based training potentially provides additional benefits such as cost-benefit, social support, and motivation. However, the efficacy of group preoperative PFT has not been reported. This study aims to determine the effect of group preoperative PFT on transient urinary incontinence after HoLEP in a prospective cohort of patients and to identify any potential predictors of transient urinary incontinence after HoLEP.

In this study, the investigators will recruit approximately 50 patients in each cohort (total 100) and will be followed over time to collect data on both the exposure (group PFT) and the outcome (incidence of urinary incontinence 1 month and 3 months after HoLEP). Potential confounding variables, such as patient demographics, preoperative imaging, and operative data, will be collected and analyzed. The results of this study have the potential to inform the development of effective preoperative interventions for the management of transient urinary incontinence after HoLEP.

Вмешательства

• Поведенческое Group preoperative pelvic floor training
  Patients will receive PFT from a trained physical therapist delivered in a group setting of 8-10 people. The investigators allow patients in the PFT group to attend group classes as many times as they want prior to surgery to see if the frequency of training has an effect on outcomes. The treatment group could be required to go to at least 1 group class 4 weeks prior to their procedure, but they could be welcome to attend more if they want further practice and review of the material. A 45-minute

Первичные конечные точки

• Incidence of urinary incontinence at 1 month [Срок оценки: 1 month after the operation]
• Incidence of urinary incontinence at 3 months [Срок оценки: 3 months after the operation]

Вторичные конечные точки (7)

• The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 1 month [Срок оценки: 1 month after the operation]
• The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form at 3 months [Срок оценки: 3 months after the operation]
• The International Prostate Symptom Score at 1 month [Срок оценки: 1 month after the operation]
• The International Prostate Symptom Score at 3 months [Срок оценки: 3 months after the operation]
• Pelvic floor muscle strength at 1 month [Срок оценки: 1 month after the operation]
• Pelvic floor muscle strength at 3 months [Срок оценки: 3 months after the operation]
• Patient satisfaction [Срок оценки: Immediately after the completion of the PFT program or soon thereafter]

Критерии участия

Критерии включения

• Consecutive patients with a diagnosis of BPH with a plan to undergo HoLEP.
• Between the age of 50-90.
• Ability to understand and provide informed consent.

Критерии исключения

• Patients whom inability to carry out PFT protocol.
• Patients unwilling or unable to complete follow up care.
• Severe urinary incontinence due to a history of neurological diseases such as a cerebrovascular accident or spinal cord injuries.
• Patients whom inability to read and understand the English language.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Публикации

• Gilling PJ, Wilson LC, King CJ, Westenberg AM, Frampton CM, Fraundorfer MR. Long-term results of a randomized trial comparing holmium laser enucleation of the prostate and transurethral resection of the prostate: results at 7 years. BJU Int. 2012 Feb;109(3):408-11. doi: 10.1111/j.1464-410X.2011.10359.x. Epub 2011 Aug 23. PMID 21883820
• Sun F, Sun X, Shi Q, Zhai Y. Transurethral procedures in the treatment of benign prostatic hyperplasia: A systematic review and meta-analysis of effectiveness and complications. Medicine (Baltimore). 2018 Dec;97(51):e13360. doi: 10.1097/MD.0000000000013360. PMID 30572440
• Lerner LB, McVary KT, Barry MJ, Bixler BR, Dahm P, Das AK, Gandhi MC, Kaplan SA, Kohler TS, Martin L, Parsons JK, Roehrborn CG, Stoffel JT, Welliver C, Wilt TJ. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART II-Surgical Evaluation and Treatment. J Urol. 2021 Oct;206(4):818-826. doi: 10.1097/JU.0000000000002184. Epub 2021 Aug 13. PMID 34384236
• Cho MC, Park JH, Jeong MS, Yi JS, Ku JH, Oh SJ, Kim SW, Paick JS. Predictor of de novo urinary incontinence following holmium laser enucleation of the prostate. Neurourol Urodyn. 2011 Sep;30(7):1343-9. doi: 10.1002/nau.21050. Epub 2011 Apr 28. PMID 21538499
• Nam JK, Kim HW, Lee DH, Han JY, Lee JZ, Park SW. Risk Factors for Transient Urinary Incontinence after Holmium Laser Enucleation of the Prostate. World J Mens Health. 2015 Aug;33(2):88-94. doi: 10.5534/wjmh.2015.33.2.88. Epub 2015 Aug 19. PMID 26331125
• Shigemura K, Tanaka K, Yamamichi F, Chiba K, Fujisawa M. Comparison of Predictive Factors for Postoperative Incontinence of Holmium Laser Enucleation of the Prostate by the Surgeons' Experience During Learning Curve. Int Neurourol J. 2016 Mar;20(1):59-68. doi: 10.5213/inj.1630396.198. Epub 2016 Mar 9. PMID 27032559
• Houssin V, Olivier J, Brenier M, Pierache A, Laniado M, Mouton M, Theveniaud PE, Baumert H, Mallet R, Marquette T, Villers A, Robert G, Rizk J. Predictive factors of urinary incontinence after holmium laser enucleation of the prostate: a multicentric evaluation. World J Urol. 2021 Jan;39(1):143-148. doi: 10.1007/s00345-020-03169-0. Epub 2020 Mar 26. PMID 32219512
• Pan LH, Lin MH, Pang ST, Wang J, Shih WM. Improvement of Urinary Incontinence, Life Impact, and Depression and Anxiety With Modified Pelvic Floor Muscle Training After Radical Prostatectomy. Am J Mens Health. 2019 May-Jun;13(3):1557988319851618. doi: 10.1177/1557988319851618. PMID 31092098

Идентификаторы

NCT: NCT05719220 · 23-38400

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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