Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia

Официальное название

Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia: A Multicentre, Randomized, Single-Blind, Four-Arm Controlled Trial

Обзор

This study will evaluate the safety and effectiveness of different surgical treatments for men with small-volume benign prostatic hyperplasia (BPH). Men with small-volume BPH may still have bothersome lower urinary tract symptoms and bladder outlet obstruction, and the best surgical treatment for this group remains uncertain. In this multicentre, randomized, single-blind, four-arm controlled trial, 932 eligible men aged 40 to 80 years will be assigned in a 1:1:1:1 ratio to one of four groups: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation of the prostate alone, transurethral resection of the prostate (TURP), or transurethral incision of the prostate (TUIP). The main goal of the study is to compare the incidence of bladder neck contracture at 6 months after surgery. Secondary outcomes include safety outcomes and changes in urinary symptoms, urinary flow rate, pain score, and symptom response at 3 and 6 months after surgery. Exploratory outcomes include changes in post-void residual urine volume and sexual function scores. Additional exploratory long-term outcomes will also be assessed at 12 months after surgery.

Подробное описание

Benign prostatic hyperplasia (BPH) is a common condition in aging men and may lead to bladder outlet obstruction and lower urinary tract symptoms. In some patients, clinically significant obstruction and symptoms can occur even when prostate volume is relatively small. Small-volume BPH should not necessarily be regarded as a mild condition, because these patients may still experience bothersome symptoms, impaired urinary flow, increased post-void residual urine volume, and bladder outlet obstruction. In this subgroup, obstruction may be related not only to adenomatous enlargement, but also to an elevated, narrow, or fibrotic bladder neck. Surgical treatment of small-volume BPH remains challenging, and the optimal surgical approach has not been clearly established.

This study is a multicentre, randomized, single-blind, four-arm controlled clinical trial designed to evaluate the safety and efficacy of different surgical strategies for patients with small-volume BPH. Eligible male participants aged 40 to 80 years with a prostate volume of less than 30 mL and clinically significant lower urinary tract symptoms or impaired voiding function will be enrolled. A total of 932 participants will be randomly assigned in a 1:1:1:1 ratio to one of four treatment groups: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation of the prostate alone, transurethral resection of the prostate (TURP), or transurethral incision of the prostate (TUIP).

The primary objective of the study is to compare the incidence of bladder neck contracture at 6 months after surgery among the treatment groups. Secondary outcomes include safety outcomes and changes in International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), Visual Analogue Scale (VAS) score, and IPSS response rate at 3 and 6 months after surgery. Exploratory outcomes include changes in post-void residual urine volume and sexual function scores, including the International Index of Erectile Function-5 (IIEF-5) and the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). Additional exploratory long-term outcomes will be assessed at 12 months after surgery, including delayed bladder neck contracture, maintenance of urinary function, late adverse events, and the need for reintervention.

The study is designed to provide high-quality evidence on the comparative safety and effectiveness of these four surgical approaches in men with small-volume BPH and to help define an optimal surgical strategy for this specific patient population.

Вмешательства

• Процедура Thulium Laser Enucleation of the Prostate Combined With Bladder Neck Incision
  Participants will undergo transurethral thulium laser enucleation of the prostate combined with bladder neck incision. Hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system. After enucleation and haemostasis, the bladder neck will be assessed intraoperatively, and bladder neck incision will be performed according to protocol-defined anatomical and obstructive findings when considered safe by the operating surgeon.
• Процедура Thulium Laser Enucleation of the Prostate
  Participants will undergo transurethral thulium laser enucleation of the prostate alone. Hyperplastic prostatic tissue will be enucleated along the surgical capsule plane using a thulium fibre laser system, followed by haemostasis of the surgical wound. No bladder neck incision will be performed as part of the assigned intervention.
• Процедура Transurethral Resection of the Prostate
  Participants will undergo transurethral resection of the prostate using a conventional resectoscope. Obstructive hyperplastic prostatic tissue will be resected transurethrally according to standard TURP principles to relieve obstruction while avoiding excessive resection and injury to adjacent structures.
• Процедура Transurethral Incision of the Prostate
  Participants assigned to this intervention will undergo transurethral incision of the prostate using standard endoscopic equipment. One or two longitudinal incisions will be made at the bladder neck and prostatic urethra according to prostate morphology and the degree of obstruction. The procedure aims to relieve bladder outlet obstruction without substantial prostatic tissue resection. The incision site and extent will be individualized according to intraoperative anatomy, with careful avoidanc

Первичные конечные точки

• Incidence of Bladder Neck Contracture [Срок оценки: 6 months after surgery (180 ± 7 days)]

Вторичные конечные точки (9)

• Incidence of Postoperative Retrograde Ejaculation [Срок оценки: Up to 6 months after surgery]
• Incidence of Device-Related New-Onset Severe Urinary Retention [Срок оценки: Up to 6 months after surgery]
• Incidence of Device-Related New-Onset Stress Urinary Incontinence [Срок оценки: Up to 6 months after surgery]
• Incidence of Device-Related Bleeding Events Requiring Blood Transfusion [Срок оценки: Up to 6 months after surgery]
• Incidence of Device-Related Urethral or Prostatic Capsule Rupture Requiring Surgical Intervention [Срок оценки: Up to 6 months after surgery]
• Change From Baseline in International Prostate Symptom Score (IPSS) [Срок оценки: 3 months and 6 months after surgery]
• IPSS Response Rate [Срок оценки: 3 months and 6 months after surgery]
• Change From Baseline in Maximum Urinary Flow Rate (Qmax) [Срок оценки: 3 months and 6 months after surgery]
• Change From Baseline in Visual Analogue Scale (VAS) Score [Срок оценки: 3 months and 6 months after surgery]

Критерии участия

Критерии включения

• Male patients aged 40-80 years.
• Diagnosis of benign prostatic hyperplasia (BPH) and scheduled to undergo surgical treatment.
• International Prostate Symptom Score (IPSS) of at least 12, maximum urinary flow rate of no more than 15 mL/s, with a voided volume greater than 150 mL.
• Prostate volume of less than 30 mL measured by transrectal ultrasound (TRUS), calculated as length × width × height × 0.52.
• Ability, as assessed by the investigator, to understand the study requirements and complete the scheduled treatment, follow-up visits, and study-related assessments.

Критерии исключения

• Inability or refusal to provide written informed consent, or inability to comply with the required follow-up schedule.
• Prostate-specific antigen (PSA) level of 10 ng/mL or higher, unless prostate cancer has been excluded by biopsy.
• Confirmed or suspected prostate or bladder malignancy.
• Pre-existing bladder neck contracture or urethral stricture before surgery.
• Known coagulation disorder or abnormal coagulation function.
• Neurogenic bladder or detrusor underactivity that may affect bladder or urethral sphincter function.
• Benign prostatic hyperplasia (BPH) complicated by acute urinary tract infection, acute prostatitis, or bacterial prostatitis.
• History of prostate surgery, urethral stricture, or neurogenic bladder.
• History of prostate cancer or pelvic radiotherapy.
• Severe cardiovascular disease, pulmonary disease, or other systemic disease that, in the investigator's judgment, would make the patient unable to tolerate surgery.
• Participation in another clinical trial related to benign prostatic hyperplasia (BPH) within 3 months before enrolment.
• Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chinese PLA General Hospital — Пекин

Публикации

• Gomes CM, Nunes RV, Araujo RM, Sacomani CR, Trigo-Rocha FE, Bruschini H, Srougi M. Urodynamic evaluation of patients with lower urinary tract symptoms and small prostate volume. Urol Int. 2008;81(2):129-34. doi: 10.1159/000144049. Epub 2008 Aug 29. PMID 18758208
• Gravas S, Gacci M, Gratzke C, Herrmann TRW, Karavitakis M, Kyriazis I, Malde S, Mamoulakis C, Rieken M, Sakalis VI, Schouten N, Speakman MJ, Tikkinen KAO, Cornu JN. Summary Paper on the 2023 European Association of Urology Guidelines on the Management of Non-neurogenic Male Lower Urinary Tract Symptoms. Eur Urol. 2023 Aug;84(2):207-222. doi: 10.1016/j.eururo.2023.04.008. Epub 2023 May 17. PMID 37202311
• Dias US Jr, de Moura MRL, Viana PCC, de Assis AM, Marcelino ASZ, Moreira AM, Leite CC, Cerri GG, Carnevale FC, Horvat N. Prostatic Artery Embolization: Indications, Preparation, Techniques, Imaging Evaluation, Reporting, and Complications. Radiographics. 2021 Sep-Oct;41(5):1509-1530. doi: 10.1148/rg.2021200144. Epub 2021 Aug 20. PMID 34415807
• Lee SWH, Chan EMC, Lai YK. The global burden of lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A systematic review and meta-analysis. Sci Rep. 2017 Aug 11;7(1):7984. doi: 10.1038/s41598-017-06628-8. PMID 28801563
• 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 I-Initial Work-up and Medical Management. J Urol. 2021 Oct;206(4):806-817. doi: 10.1097/JU.0000000000002183. Epub 2021 Aug 13. PMID 34384237

Идентификаторы

NCT: NCT07569874 · ThuLEP-BNI-2026-161

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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