HoLEP-ThuLEP Prospective Trial

NCT07565961 | Recruiting

• 1 other identifier: 26-004
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

BPH (Benign Prostatic Hyperplasia)

Keywords

BPH; BPS; Enculeation; Prostate; Laser; HOLEP; THULEP

Outcome Measures

Primary Outcomes (1)

• Change in International Prostate Symptom Score (IPSS) at 12 months

  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).

  Baseline (day before surgery) and 12 months postoperatively

Secondary Outcomes (15)

• 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)

Study Arms (2)

ThuLEP Arm

EXPERIMENTAL

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.

Procedure: Thulium Laser Enucleation of the Prostate (ThuLEP)

HoLEP Arm

ACTIVE COMPARATOR

Holmium Laser Enucleation of the Prostate using a holmium:YAG laser system. Considered the current reference standard for endoscopic enucleation of the prostate.

Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)

Interventions

Thulium Laser Enucleation of the Prostate (ThuLEP) PROCEDURE

Endoscopic enucleation of the prostatic adenoma with a pulsed thulium laser; performed in arm 1

ThuLEP Arm

Holmium Laser Enucleation of the Prostate (HoLEP) PROCEDURE

Endoscopic enucleation of the prostatic adenoma with a holmium:YAG laser; performed in arm 2

HoLEP Arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Proven or suspected prostate cancer
• Previous surgery of the prostate or urethra
• Neurogenic bladder dysfunction
• Anticoagulation therapy that cannot be paused perioperatively

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Urologische Klinik und Poliklinik, LMU Klinikum

Munich, Bavaria, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yannic Volz, PD Dr. med.

  LMU University Hospital

  STUDY CHAIR

• Patrick Keller, PD Dr. med.

  LMU University Hospital

  STUDY CHAIR

Central Study Contacts

Yannic Volz, PD Dr. med.

CONTACT

+498944000; yannic.volz@med.uni-muenchen.de

Patrick Keller, PD Dr. med.

CONTACT

patrick.keller@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Model Details: 1:1 randomization to ThuLEP or HoLEP using sealed envelopes drawn preoperatively

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)