Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial

Study Overview
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Brief Summary
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The primary objective of the study is to compare Trans-Perineal Laser Ablation of Prostate versus Trans-Urethral Resection of Prostate in the immediate impact on post-operative pain; in terms of relief in benign prostatic obstruction and preservation of the ejaculatory function in the short term (at 1, 3 and 6 months). The secondary objective of the study is the evaluation of the long-term deobstructive effectiveness (12 months).

Detailed Description
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Consecutive patients coming to our institution affected by benign prostatic obstruction (BPO) with indication to surgery and strong need of ejaculatory preservation will be enrolled in the present randomised controlled trial study after counseling. After an informed consent is obtained, uroflowmetry with calculation of the post-voiding residual volume (PVR), a transrectal ultrasonography to estimate prostate volume (PVol), the international prostate symptoms score (IPSS) questionnaire with quality of life (QoL) assessment, and the evaluation of the ejaculatory sexual function will be performed in all patients. Trans-Perineal Laser Ablation of Prostate (TPLA) will be performed using the EchoLaser combined system (Elesta, Italy). During the procedure, two 21G spinal needles are inserted transperineally in the peri-urethral area under ultrasound-guidance. By optical fibers, a maximum energy of 1800 J at a power of 3 Watts is delivered. If necessary, the fibers are eventually pulled-back. Immediately after the procedure, the patients will be asked to fill in the Visual Analogue Scale (VAS) for the assessment of the pain perceived. Perioperative data and postoperative data including assessment of ejaculatory function will be analyzed at different time points.

Official Title
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Transperineal Laser Ablation Of Prostate Versus Transurethral Prostate Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial

Conditions
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Prostate Hyperplasia, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Benign Prostatic Hypertrophy With Outflow Obstruction

Intervention / Treatment
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* Procedure: Trans-Perineal Laser Ablation of Prostate
* Procedure: Trans-Urethral Resection of Prostate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed written informed consent patient able to complete the Whole protocol IPSS score ≥ 10 Maximum urinary flow rate < 15 ml/sec Prostate volume at preop. ultrasonography < 100 mL normal urinalysis (all of the above) Exclusion Criteria: former prostate surgery prostate cancer (history) urethral stricture (history) Marion's disease (history) bladder stones median obstructive lobe, as defined by a > 1 cm of prostate abutting in the bladder lumen at ultrasonography neurological conditions potentially impacting on the bladder voiding (at least one of the above)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: TPLA (Trans-Perineal Laser Ablation of Prostate)<br>Participants who undergo Trans-Perineal Laser Ablation of Prostate | Procedure: Trans-Perineal Laser Ablation of Prostate<br>* TPLA treatment will be performed using the EchoLaser EVO system (Elesta SpA - Calenzano, FI, Italy). EchoLaser EVO consists of four echolasers, a multi-source laser system with a wavelength of 1064nm and Echolaser Smart Interface (ESI), a treatment planning device for safely inserting introductor needles and optical fibers into prostate tissue. EchoLaser therapy is a micro-invasive percutaneous procedure that uses laser light transmitted through applicators (optical fibers) for a few minutes, causing a heating of the affected tissue to its irreversible damage in situ, without the need to remove it. EchoLaser therapy, through flat-tip fibers, produces an ellipsoidal clotting area (area where the tissue has irreversible damage). EchoLaser therapy will be performed under ultrasound guidance.<br>|
| Active Comparator: TURP (Trans-Urethral Resection of Prostate)<br>Participants who undergo the standard treatment, namely Trans-Urethral Resection of Prostate | Procedure: Trans-Urethral Resection of Prostate<br>* TURP is the gold standard for the treatment of benign prostatic obstruction. It will be performed by using a bipolar energy resectoscope. The procedure will be carried out with patient in a lithotomic position.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analogue Scale (VAS) | Visual Analogue Scale. A standardized assessment of perceived pain. Scaled from a minimum of 0 to a maximum of 10 points. | Differences between preoperative and 4-hours postoperative | 
| Change in Ejaculatory function as assessed by the Male Sexual Health Questionnaire - Ejaculatory function domain (EJ-MSHQ) | EJ-MSHQ questionnaire will be used for a standardized assessment. Scaled from a minimum of 0 to a maximum of 25 points. | Differences among preoperative status versus 1, 3, 6, 12 months after surgery | 
| Changes in Sexual function as assessed by the International Index of Erectile Function Questionnaire (IIEF) | IIEF questionnaire will be used for a standardized assessment. Scaled from a minimum of 0 to a maximum of 25 points. | Differences among preoperative status versus 1, 3, 6, 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in International Prostate Symptom Score (IPSS) | Standardized Evaluation of the relief in prostate symptoms score. Scaled from a minimum of 0 to a maximum of 35 points. | Differences among preoperative status versus 1, 3, 6, 12 months after surgery | 
| Changes in Quality of Life (QoL) | Standardized Evaluation of the improvement in Quality of Life. Scaled from a minimum of 0 to a maximum of 6 points. | Differences among preoperative status versus 1, 3, 6, 12 months after surgery | 
| Changes in the maximum urinary flow rate at Uroflowmetry (Qmax) | objective improvement of maximum urinary flow rate at uroflowmetry. Measured in ml/s, scaled from 0 to the maximum of the distribution (usually no more than 50 ml/s) | Differences among preoperative status versus 1, 3, 6, 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TPLA, TURP, BPH, BPO, LUTS