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

Not Applicable

Completed

• Conditions: Benign Prostatic Hypertrophy With Outflow Obstruction; Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy; Prostate Hyperplasia
• Interventions: Procedure: Trans-Perineal Laser Ablation of Prostate; Procedure: Trans-Urethral Resection of Prostate

• Registration Number: NCT04781049
• Lead Sponsor: San Carlo di Nancy Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-04
• Primary Completion: 2021-09-20
• Study Completion: 2022-10-06
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 51

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPLA (Trans-Perineal Laser Ablation of Prostate)	Trans-Perineal Laser Ablation of Prostate	Participants who undergo Trans-Perineal Laser Ablation of Prostate
TURP (Trans-Urethral Resection of Prostate)	Trans-Urethral Resection of Prostate	Participants who undergo the standard treatment, namely Trans-Urethral Resection of Prostate

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in International Prostate Symptom Score (IPSS)	Differences among preoperative status versus 1, 3, 6, 12 months after surgery	Standardized Evaluation of the relief in prostate symptoms score. Scaled from a minimum of 0 to a maximum of 35 points.
Changes in Quality of Life (QoL)	Differences among preoperative status versus 1, 3, 6, 12 months after surgery	Standardized Evaluation of the improvement in Quality of Life. Scaled from a minimum of 0 to a maximum of 6 points.
Changes in the maximum urinary flow rate at Uroflowmetry (Qmax)	Differences among preoperative status versus 1, 3, 6, 12 months after surgery	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)

Trial Locations

Locations (1)

San Carlo di Nancy Hospital; 🇮🇹 Roma, RM, Italy