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

San Carlo di Nancy Hospital

Status: Completed

Conditions: Benign Prostatic Hypertrophy; Prostate Hyperplasia; Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy With Outflow Obstruction

Treatments: Procedure: Trans-Urethral Resection of Prostate; Procedure: Trans-Perineal Laser Ablation of Prostate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04781049

1580/CELazio1

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 51 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

TPLA (Trans-Perineal Laser Ablation of Prostate)

Experimental group

Description:

Participants who undergo Trans-Perineal Laser Ablation of Prostate

Treatment:

Procedure: Trans-Perineal Laser Ablation of Prostate

TURP (Trans-Urethral Resection of Prostate)

Active Comparator group

Description:

Participants who undergo the standard treatment, namely Trans-Urethral Resection of Prostate

Treatment:

Procedure: Trans-Urethral Resection of Prostate