跳至主要内容
临床试验/NCT07334730
NCT07334730尚未招募不适用

A Prospective Analysis of the Effects of Holmium Laser Enucleation (HoLEP) and Thulium Laser Enucleation (ThuLEP) on Continence, Urethral Stricture, and Sexual Function in Benign Prostatic Hyperplasia

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Number of Participants with Postoperative Urethral Stricture or Urinary Incontinance

研究概览

简要总结

This study aims to evaluate the effects of Holmium Laser Enucleation of the Prostate (HoLEP) and Thulium Laser Enucleation of the Prostate (ThuLEP), performed for the treatment of benign prostatic hyperplasia (BPH), on the following parameters: urinary continence, development of urethral or bladder neck stricture, and sexual function, including erectile function, ejaculation, and libido.

详细描述

Benign prostatic hyperplasia (BPH) is a progressive condition commonly affecting men, characterized by lower urinary tract symptoms (LUTS) that increase in prevalence and severity with age. Although medical therapy is effective for many patients, approximately 5% experience symptom progression requiring surgical intervention. While transurethral resection of the prostate (TURP) has long been considered the standard surgical treatment, technological advancements have enabled the widespread use of anatomical endoscopic enucleation of the prostate (AEEP) employing various laser modalities. Among these, Holmium laser enucleation of the prostate (HoLEP) and thulium laser enucleation of the prostate (ThuLEP) are established minimally invasive techniques used in the surgical management of BPH.

Detailed Description

Recent studies have demonstrated comparable perioperative and functional outcomes between HoLEP and ThuLEP, with no significant differences reported in terms of urinary retention, stress urinary incontinence, bladder neck contracture, or urethral stricture formation. However, postoperative evolution of urinary continence, overactive bladder symptoms, and sexual function remains a clinically relevant concern, particularly regarding patients' quality of life. Despite the increasing use of laser-based enucleation techniques, comparative data focusing on continence status, urethral or bladder neck stricture development, and sexual function outcomes remain limited.

To reduce postoperative complications, several surgical technique modifications have been introduced, including en bloc enucleation, two-lobe and three-lobe techniques, as well as urethral mucosa-preserving approaches such as single-N and double-N techniques. These modifications aim to preserve periurethral and paracollicular tissues, particularly in proximity to the verumontanum, thereby potentially improving functional outcomes.

The prevalence of BPH continues to rise in the aging population, often accompanied by systemic comorbidities and the use of anticoagulant or antithrombotic medications, which are associated with an increased risk of postoperative bleeding and hemorrhagic complications. Consequently, there is a growing need to evaluate the long-term outcomes of minimally invasive surgical techniques in this patient population.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Diagnosis of benign prostatic hyperplasia (BPH).
  • Indication for surgical treatment of BPH.
  • Male patients aged 40-90 years.

排除标准

  • Patients with active urinary tract infection (UTI).
  • Patients at high risk who cannot undergo spinal or general anesthesia.
  • Patients with uncontrolled bleeding diathesis.

结局指标

主要结局

Number of Participants with Postoperative Urethral Stricture or Urinary Incontinance

时间窗: Within 6 months after surgery

Postoperative urethral stricture was defined as a maximum urinary flow rate (Qmax) of less than 15 mL/s on uroflowmetry at the first postoperative month, accompanied by a voiding curve pattern consistent with urethral obstruction. Postoperative urinary incontinence was defined as the presence of patient-reported urge or stress-type incontinence at the first postoperative month, supported by an increased score on the International Consultation on Incontinence Questionnaire (ICIQ)

次要结局

  • Number of participants assessed for sexual function(within 6 months after surgery)
  • Number of participants with surgery-related complications(Within 6 months after surgery)
  • Number of participants presenting with lower urinary tract symptoms(Within 6 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Halil Tosun

Halil Tosun Assistant Proffessor

TC Erciyes University

研究点 (1)

Loading locations...

相似试验