Prospective Randomized Comparative Study Evaluating Functional and Perioperative Outcomes After Thulium Laser Enucleation of the Prostate (ThuLEP) Versus Holmium Laser Enucleation of the Prostate (HoLEP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in International Prostate Symptom Score (IPSS) at 12 months
研究概览
简要总结
Benign prostatic hyperplasia (BPH) is a very common condition in older men. As the prostate enlarges, it can press on the urethra and make urination difficult. Typical symptoms include a weak urinary stream, frequent urination, getting up at night to urinate, and a feeling that the bladder is not fully empty. When medication is no longer sufficient, surgical removal of the inner part of the prostate ("enucleation") is the recommended treatment.
Two modern laser techniques are used for this operation. Holmium Laser Enucleation of the Prostate (HoLEP) is currently considered the reference standard, with very good long-term results and a low rate of re-operations. Thulium Laser Enucleation of the Prostate (ThuLEP) using a pulsed thulium laser is a newer alternative. Because the laser energy is delivered in short pulses, ThuLEP may allow more precise tissue cutting and better control of bleeding during surgery.
So far, only limited high-quality randomized data directly compare the two techniques, particularly for patient-reported outcomes such as urinary symptoms, continence, and erectile function.
Purpose of the study The HoT-Trial investigates whether ThuLEP is as effective as HoLEP for men who need surgery for an enlarged prostate, and whether there are differences in recovery, complication rates, urinary symptoms, continence, and erectile function after surgery.
Research question Does ThuLEP lead to a similar improvement in lower urinary tract symptoms (LUTS) as HoLEP 12 months after surgery, measured by the change in the International Prostate Symptom Score (IPSS)?
How the study works A total of 150 men aged 18 years or older with clinically relevant BPH, an IPSS of 8 or higher, a prostate volume above 40 ml, and an indication for surgery will take part. Each participant will be randomly assigned (1:1) to either ThuLEP or HoLEP. Participants are blinded to the assigned technique (single-blind design). Both procedures are established, guideline-recommended treatments; taking part in the study does not add any risks beyond standard care.
Before surgery, participants complete standardized questionnaires (IPSS, ICIQ-SF, IIEF) and undergo uroflowmetry and residual urine measurement. Surgery is performed according to randomization. Participants are then followed up in the urology outpatient clinic at discharge and at 3, 6, and 12 months after surgery. The same measurements and questionnaires are repeated at each visit.
Primary outcome Change in IPSS from baseline to 12 months after surgery.
Secondary outcomes Maximum urinary flow rate (Qmax) and post-void residual urine; continence (ICIQ-SF) and erectile function (IIEF); operative time, laser time, blood loss, transfusion rate; catheter indwelling time and length of hospital stay; peri- and postoperative complications graded by the Clavien-Dindo classification; and the rate of re-intervention or re-catheterization within 12 months.
Setting and timeline The study is conducted as a single-center trial at the Department of Urology, Ludwig-Maximilians-University Munich, Germany. Recruitment runs for approximately two years, with up to 12 months of follow-up per participant. The total study period is planned from April 2026 to April 2029.
By directly comparing the two laser enucleation techniques in a randomized setting, the HoT-Trial aims to help patients and physicians choose the most suitable surgical treatment for benign prostatic hyperplasia.
详细描述
Background and rationale Benign prostatic syndrome (BPS) is among the most frequent urological diseases in older men and a leading cause of treatment-requiring lower urinary tract symptoms (LUTS). For moderately to severely enlarged prostates, endoscopic enucleation procedures have become the surgical gold standard. Holmium Laser Enucleation of the Prostate (HoLEP) is considered the reference technique, with excellent long-term functional outcomes and a low re-intervention rate.
Thulium Laser Enucleation of the Prostate (ThuLEP) using pulsed thulium laser technology (wavelength approximately 2013 nm) has been introduced as an alternative enucleation procedure. The high absorption in water enables precise tissue dissection while allowing effective hemostasis, and the pulsed energy delivery may offer advantages in tissue control, precision, and intraoperative hemostasis. However, adequately powered prospective randomized trials directly comparing ThuLEP and HoLEP remain scarce, and patient-reported outcomes such as IPSS and ICIQ-SF are insufficiently studied.
Objectives The primary objective is to compare the improvement of LUTS between ThuLEP and HoLEP, measured as the change in IPSS from baseline to 12 months postoperatively. Secondary objectives include comparison of functional outcomes (Qmax, post-void residual urine), urinary continence (ICIQ-SF), erectile function (IIEF), perioperative parameters (operative time, laser time, blood loss, catheter indwelling time, length of hospital stay), complication rates (Clavien-Dindo), and re-intervention and re-catheterization rates.
Design Prospective, randomized, single-blind (participant-blinded), interventional comparative trial with 1:1 allocation to ThuLEP or HoLEP. Randomization is performed using sealed envelopes drawn preoperatively. Follow-up duration is 12 months per participant.
Study procedures After establishing the indication for surgical treatment of BPS, patients are screened and informed. Following written informed consent, patients are randomized. Baseline assessment (IPSS, Qmax, post-void residual urine, IIEF, ICIQ-SF) is performed the day before surgery. Surgery is performed according to randomization. Clinical baseline data (laboratory parameters, age, medications, comorbidities) and perioperative data (operative time, resection weight, laser energy) are extracted from operative and medical records. Postoperative assessments are performed at discharge and at 3, 6, and 12 months in the urology outpatient clinic, where patients are scheduled for follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, age ≥ 18 years
- •Clinically relevant benign prostatic syndrome (BPS) with an established indication for surgical treatment
- •International Prostate Symptom Score (IPSS) ≥ 8
- •Prostate volume > 40 ml
- •Signed written informed consent
排除标准
- •Proven or suspected prostate cancer
- •Previous surgery of the prostate or urethra
- •Neurogenic bladder dysfunction
- •Anticoagulation therapy that cannot be paused perioperatively
研究组 & 干预措施
HoLEP Arm
Holmium Laser Enucleation of the Prostate using a holmium:YAG laser system. Considered the current reference standard for endoscopic enucleation of the prostate.
干预措施: Holmium Laser Enucleation of the Prostate (HoLEP) (Procedure)
ThuLEP Arm
Thulium Laser Enucleation of the Prostate using a pulsed thulium laser system (wavelength approximately 2013 nm). The enucleation is performed according to the institutional standard operating procedure.
干预措施: Thulium Laser Enucleation of the Prostate (ThuLEP) (Procedure)
结局指标
主要结局
Change in International Prostate Symptom Score (IPSS) at 12 months
时间窗: Baseline (day before surgery) and 12 months postoperatively
The IPSS is a validated 7-item questionnaire assessing lower urinary tract symptoms. Total score ranges from 0 to 35, with higher scores indicating more severe symptoms. The primary endpoint is the difference between baseline IPSS (day before surgery) and IPSS at 12 months postoperatively (ΔIPSS).
次要结局
- Maximum urinary flow rate (Qmax)(Baseline, 3, 6, and 12 months postoperatively)
- Post-void residual urine volume (PVR)(Baseline, 3, 6, and 12 months postoperatively)
- Urinary incontinence - ICIQ-SF score(Baseline, 3, 6, and 12 months postoperatively)
- Erectile function - IIEF score(Baseline, 3, 6, and 12 months postoperatively)
- Operative time(Intraoperative (day of surgery))
- Laser time(Intraoperative (day of surgery))
- Morcellation time(Intraoperative (day of surgery))
- Hemoglobin drop(Preoperative to postoperative day 1)
- Transfusion rate(During index hospital admission (typically up to 7 days))
- Catheter indwelling time(From surgery until catheter removal (typically within 7 days))
- Length of hospital stay (LOS)(During index hospital admission (typically up to 7 days))
- Perioperative complications - Clavien-Dindo(Up to 12 months postoperatively)
- Re-intervention and re-catheterization rate(Within 12 months postoperatively)
- Stricture rate (urethra)(Within 12 months postoperatively)
- Bladder neck stenosis(Within 12 months postoperatively)
研究者
Yannic Volz
Consultant and Assistant Professor for Urology
Ludwig-Maximilians - University of Munich