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

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ClinicalTrials.gov Identifier: NCT04781049
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : March 4, 2021
Sponsor:
Collaborator:
Elesta S.R.L.
Information provided by (Responsible Party):
Riccardo Bertolo, 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).


Condition or disease Intervention/treatment Phase
Prostate Hyperplasia Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy Benign Prostatic Hypertrophy With Outflow Obstruction Procedure: Trans-Perineal Laser Ablation of Prostate Procedure: Trans-Urethral Resection of Prostate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transperineal Laser Ablation Of Prostate Versus Transurethral Prostate Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : April 2022

Arm Intervention/treatment
Experimental: TPLA (Trans-Perineal Laser Ablation of Prostate)
Participants who undergo Trans-Perineal Laser Ablation of Prostate
Procedure: Trans-Perineal Laser Ablation of Prostate
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.

Active Comparator: TURP (Trans-Urethral Resection of Prostate)
Participants who undergo the standard treatment, namely Trans-Urethral Resection of Prostate
Procedure: Trans-Urethral Resection of Prostate
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 Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study is investigating a novel micro-invasive treatment for benign prostatic obstruction. Thus, being male and having prostate in situ is mandatory.
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04781049


Contacts
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Contact: Riccardo Bertolo, MD, PhD +393332449956 riccardobertolo@hotmail.it

Locations
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Italy
San Carlo di Nancy Hospital Recruiting
Roma, RM, Italy, 00175
Contact: Riccardo Bertolo, MD, PhD    +393332449956    riccardobertolo@hotmail.it   
Principal Investigator: Pierluigi Bove, MD         
Sub-Investigator: Chiara Cipriani, PhD         
Sponsors and Collaborators
San Carlo di Nancy Hospital
Elesta S.R.L.
Investigators
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Principal Investigator: Pierluigi Bove, MD San Carlo di Nancy Hospital
Publications of Results:

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Responsible Party: Riccardo Bertolo, Assistant Professor, San Carlo di Nancy Hospital
ClinicalTrials.gov Identifier: NCT04781049    
Other Study ID Numbers: 1580/CELazio1
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study will be subject of publication. The data will be available upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riccardo Bertolo, San Carlo di Nancy Hospital:
TPLA
TURP
BPH
BPO
LUTS
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Hypertrophy
Pathologic Processes
Prostatic Diseases
Pathological Conditions, Anatomical