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NCT Number: NCT04781049

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

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).

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Key information

Conditions

Prostate Hyperplasia Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy Benign Prostatic Hypertrophy With Outflow Obstruction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

San Carlo di Nancy Hospital

Roma, RM, 00175, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Trans-Perineal Laser Ablation of Prostate

Procedure

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.

Trans-Urethral Resection of Prostate

Procedure

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.

Primary outcomes

  1. Change in Visual Analogue Scale (VAS)

    Time frame: 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.

  2. Change in Ejaculatory function as assessed by the Male Sexual Health Questionnaire - Ejaculatory function domain (EJ-MSHQ)

    Time frame: 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.

  3. Changes in Sexual function as assessed by the International Index of Erectile Function Questionnaire (IIEF)

    Time frame: 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 outcomes

  1. Changes in International Prostate Symptom Score (IPSS)

    Time frame: 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.

  2. Changes in Quality of Life (QoL)

    Time frame: 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.

  3. Changes in the maximum urinary flow rate at Uroflowmetry (Qmax)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

San Carlo di Nancy Hospital

Other

Collaborators

  • Elesta S.R.L.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 4, 2021
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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