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临床试验/CTRI/2025/12/099812
CTRI/2025/12/099812尚未招募不适用

A comparative observational prospective study to assess outcome in monopolar transurethral resection of the prostate (turp) vs holmium laser enucleation of the prostate (holep) in benign prostatic hyperplasia

Bhaktivedanta Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年1月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
68
试验地点
1

研究概览

简要总结

Benign prostatic hyperplasia (BPH) is most common causes of lower urinary tract symptoms (LUTS) in ageing male, with significant impact on quality of life. Surgical management is indicated in patients with severe symptoms, complications, and failure of medical management. Monopolar transurethral resection of the prostate (mTURP) has long been considered the gold standard surgical treatment, offering proven efficacy in relieving LUTS in BPH. However, mTURP is associated with some limitations such as perioperative bleeding, risk of TUR syndrome, and reduced efficiency in very large prostates.

Holmium laser enucleation of the prostate (HoLEP) is a novel, minimally invasive technique that uses the Holmium:YAG laser to enucleate the adenoma, followed by intravesical morcellation. HoLEP can be applied to all sizes prostates, uses saline irrigation (avoiding TUR syndrome), and is associated with reduced blood loss, shorter catheterisation time, and shorter hospital stay. Despite these advantages, its adoption is limited by high equipment costs, a steep learning curve, and limited availability. There is limited study on moderate size prostate glands which is most seen in BPH.

This prospective comparative study aims to evaluate and compare perioperative parameters, functional outcomes, complication rates, and patient satisfaction between mTURP and HoLEP in patients with BPH. Eligible patients will be allocated to either surgical group and followed up for 1 year. Data will be analysed to determine differences in symptom improvement, flow rate changes, hospitalisation duration, and postoperative complications. The findings of this study are expected to provide evidence-based insights into the relative merits of these two surgical modalities, helping guide clinical decision-making and optimising patient care in the context of both traditional and evolving urological practice.

研究设计

研究类型
Observational

入排标准

年龄范围
50.00 Year(s) 至 99.00 Year(s)(—)
性别
Male

入选标准

  • Male patients age more than 50 years
  • Diagnosed with symptomatic BPH with moderate to severe lower urinary tract symptoms (International Prostate Symptom Score [IPSS] more than or equal to 8).
  • Patient of BPH with recurrent UTI and recurrent Hematuria.
  • Prostate size between 40 mL and 100 mL as assessed by prostate ultrasound done by Senior Radiologist at our hospital (Voluson).
  • Patients consenting to undergo surgical treatment and participate in the study.

排除标准

  • Patients with prostate cancer confirmed by biopsy.
  • Patients with neurogenic bladder or other neurological conditions affecting voiding.
  • Previous prostate surgery.
  • Presence of active urinary tract infection.
  • • Patients unfit for anaesthesia or surgery.

研究者

发起方
Bhaktivedanta Hospital and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Harshad Kavad

Bhaktivedanta Hospital and Research Institute

研究点 (1)

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