ThuLEP vs. HoLEP vs. Monopolar Enucleation in Management of BPH

Study Overview
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Brief Summary
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Today, endoscopic enucleation of the prostate (EEP) has been recognized a method of choice for treatment of benign prostatic hyperplasia (BPH) of any size, including large-sized glands (>80 cc). The goal of our study was to compare perioperative efficacy, functional outcomes and safety of different techniques of endoscopic enucleation of the prostate (monopolar enucleation, holmium laser enucleation, thulium laser enucleation) in a single center.

Detailed Description
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HoLEP and ThuLEP or EEP have been approved by the current guidelines of the European Association of Urology for use in men with substantially enlarged prostates (>80 ml) as first-line therapy [1]. This type of operation can be performed by means of several sources of energy. To our knowledge, there were no studies comparing efficacy and complications of these three treatment modalities. In this study the investigators have evaluated efficacy of Thulium-fiber laser enucleation (120 W thulium fiber laser Urolase, IPG IRE-POLUS, Russia with wavelength of 1940 nm) and monopolar enuclation in comparision with HoLEP (VersaPulse Powersuite 100, Lumenis, USA/Israel) in reduction of LUTS secondary to BPH in a prospective randomized trial. All peri-operative parameters, urinary flow parameters, prostate size changes, erectile function and complications associated with the procedures were compared.

Official Title
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Comparative Analysis of the Efficacy and Safety of Thulium-fiber Laser Enucleation, Ho:YAG Laser Enucleation and Monopolar Enucleation in Management of BPH

Conditions
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Prostatic Hyperplasia, Benign, Prostate Adenoma, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Procedure: Thulium-fiber laser enucleation of the prostate
* Procedure: Monopolar enucleation of the prostate
* Procedure: Ho:YAG laser enucleation of the prostate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IPSS>20; maximum urinary flow rate< 10ml\s (Qmax); ineffective alfa-blockers therapy. Exclusion Criteria: histologically verified prostate cancer; history of prostatic surgery; urethral strictures; bladder stones; chronic urinary retention and cystostomy.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ThuLEP group<br>Patients who underwent thulium-fiber laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia. | Procedure: Thulium-fiber laser enucleation of the prostate<br>* A high-power (120 W) thulium fiber laser (Urolase, IPG IRE-POLUS, Russia) with wavelength of 1940 nm was used for thulium laser enucleation. In our study, we used a 600-μm laser fiber. The operations were performed at power of 60 W energy of 1.5 J and repetition rate of 40 Hz. Laser power in the verumontanum zone was decreased to 30 W and repetition rate to 20 Hz.<br>* Other names: ThuLEP;|
| Active Comparator: Monopolar enucleation group<br>Patients who underwent monopolar enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia. | Procedure: Monopolar enucleation of the prostate<br>* Monopolar enucleation was performed with a high-frequency generator (50-60 Hz), a pusher-electrode, and a hook-electrode.<br>* Other names: Monopolar enucleation;|
| Active Comparator: HoLEP group<br>Patients who underwent Ho:YAG laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia. | Procedure: Ho:YAG laser enucleation of the prostate<br>* Holmium laser enucleation of prostatic hyperplasia was performed with a 100 W laser (VersaPulse Powersuite 100, Lumenis, USA/Israel) with wavelength of 2100 nm and 550-μm fiber at the tip. The operation was performed at power of 70 W; it was decreased to 40 W when incisions were made at the verumontanum.<br>* Other names: HoLEP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPSS | International Prostate Symptom Score | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL | Quality of Life Score | Six months | 
| PVR | Post-void residual volume | Six months | 
| Qmax | Maximal urine flow rate | Six months | 
| IIEF-5 | The International Index of Erectile Function | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser, HoLEP, ThuLEP, Thulium, Thulium-fiber, EEP, monopolar enucleation, BPH