Single Center Comparative Trial of Trans-Perineal Laser Ablation Vs Water Vapor Ablation

NCT06794333 | Completed

• 2 other identifiers: SPIT_2PROGETTO SMART REGIONE TOSCANA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this clinical trial is to determine whether one of the two methods under investigation, TPLA or WVA, is superior in the treatment of BPH. Additionally, as a secondary objective, the study seeks to evaluate the potential superiority of one method over the other concerning the sexual parameters of treated participants, assessed using the International Index of Erectile Function 5 (IIEF5) and the Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EJ). The researchers will compare the two methods under investigation (TPLA and WVA) to assess the potential superiority of one over the other. Participants will:

• be randomized 1:1 between the two techniques and will undergo treatment at time 0;
• undergo follow-up including uroflowmetry and assessment of the International Prostate Symptoms Score (IPSS), IIEF5, and MSHQ-EJ questionnaires at 3, 6, and 12 months.

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia; MISTs; LUTS; Rezum Vapor Therapy; Transperineal Laser Ablation

Outcome Measures

Primary Outcomes (3)

• Improvement of Urodynamics parameters after 3 and 12 Months of Follow up

  After 3,6 and 12 months of follow-up, uroflowmetry will be conducted to assess improvements in urinary maximum flow (Qmax: ml/sec) and average flow (Qmed: ml/sec). Milliliters and seconds will be combined to calculate and report Qmax and Qmed.

  up to 12 months

• Improvement in post voided residual

  After 3,6 and 12 months of follow-up, uroflowmetry will be conducted to assess improvements post voided residual (PVR: ml). Milliliters will be used to report PVR.

  up to 12 months

• Improvement in International Prostate Symptoms Score

  After 3,6 and 12 months of follow-up International Prostate Symptom Score (IPSS) questionnaire will be administered to all participants to evaluate changes in subjective symptoms and quality of life (Lower IPSS values indicate an improvement in the symptoms reported by the patient). The IPSS ranges from 0 to 35, with scores interpreted as follows: 0-7 indicates mild symptoms, 8-19 indicates moderate symptoms, and 20-35 indicates severe symptoms.

  up to 12 months

Secondary Outcomes (4)

• Postoperative complications

  up to 3 months

• Prostate Specific Antigen (PSA) value

  up to 12 months

• sexual outcomes

  up to 12 months

• sexual outcomes

  up to 12 months

Study Arms (2)

Transperineal Laser Ablation

EXPERIMENTAL

Treatments are performed with the combined EchoLaser EVO system (Elesta SpA - Calenzano, FI). The EchoLaser EVO consists of the Echolaser X4, a multi-source laser system with a wavelength of 1064 nm, and the Echolaser Smart Interface (ESI). The procedure are performed with the patient in the lithotomy position. Local anesthesia of the perineal region and periprostatic block with lidocaine is administered under ultrasound guidance. A catheter is placed during the irradiation to allow continuous irrigation of the urethra with saline solution, protecting the urethra from temperature rise. The Echolaser Smart Interface, defines: the number and positioning of fibers, the optimal dose, and the need for multiple pullbacks. 2 to 4 21G needles are inserted simultaneously (1 or 2 per lobe) in the peri-urethral area via transperineal ultrasound guidance. A 300-micron optical fiber will be placed in each needle. Each treatment delivers a maximum energy of 1800 J per fiber with a power of 3-5 W.

Procedure: Transperineal laser Ablation

Rezum Vapor Therapy

ACTIVE COMPARATOR

The treatment involves the insertion of a radiofrequency needle into the prostate tissue and the emission of water vapor. Treatment under local anesthesia/sedation. Treatment planning using the REZUM device, with the number of injections proportional to the recommended therapeutic scheme based on prostate volume (1 injection every centimeter starting 1 cm below the bladder neck and 1 cm in front of the verumontanum). Water vapor emission for 9-second intervals with a maximum of 9 applications per patient. Three-way bladder catheter to decrease local temperature. The bladder catheter will be removed 15 days after patient discharge. Regarding the REZUM, it is a system that uses sterile single-use handpieces available within the company, where a special optics is inserted for direct visualization. The handpiece features a device that allows the manual insertion of a needle into the prostate, from which water vapor is emitted for the described treatment.

Procedure: Rezum Vapor Therapy

Interventions

Transperineal laser Ablation PROCEDURE

Treatments are performed with the combined EchoLaser EVO system (Elesta SpA - Calenzano, FI). The EchoLaser EVO consists of the Echolaser X4, a multi-source laser system with a wavelength of 1064 nm, and the Echolaser Smart Interface (ESI). The procedure are performed with the patient in the lithotomy position. Local anesthesia of the perineal region and periprostatic block with lidocaine is administered under ultrasound guidance. A catheter is placed during the irradiation to allow continuous irrigation of the urethra with saline solution, protecting the urethra from temperature rise. The Echolaser Smart Interface, defines: the number and positioning of fibers, the optimal dose, and the need for multiple pullbacks. 2 to 4 21G needles are inserted simultaneously (1 or 2 per lobe) in the peri-urethral area via transperineal ultrasound guidance. A 300-micron optical fiber will be placed in each needle. Each treatment delivers a maximum energy of 1800 J per fiber with a power of 3-5 W.

Also known as: EchoLaser EVO

Transperineal Laser Ablation

Rezum Vapor Therapy PROCEDURE

The treatment involves the insertion of a radiofrequency needle into the prostate tissue and the emission of water vapor. Treatment under local anesthesia/sedation. Treatment planning using the REZUM device, with the number of injections proportional to the recommended therapeutic scheme based on prostate volume (1 injection every centimeter starting 1 cm below the bladder neck and 1 cm in front of the verumontanum). Water vapor emission for 9-second intervals with a maximum of 9 applications per patient. Three-way bladder catheter to decrease local temperature. The bladder catheter will be removed 15 days after patient discharge. Regarding the REZUM, it is a system that uses sterile single-use handpieces available within the company, where a special optics is inserted for direct visualization. The handpiece features a device that allows the manual insertion of a needle into the prostate, from which water vapor is emitted for the described treatment.

Rezum Vapor Therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PSA levels under 4 ng/ml (if PSA is over 4 ng/ml, a multiparametric prostate magnetic resonance will be performed; if a lesion with a PIRADS score over 2 is detected, a prostate biopsy will be conducted);
• Post void residual (PVR) over 50 ml;
• Maximum flow (Qmax) under 15 ml/s;
• IPSS score over 7;
• The possibility of undergoing transrectal ultrasound to assess the size of the prostate and prostate adenoma;
• Negative urinary culture.

You may not qualify if:

• Diabetes;
• Overactive or Underachieve bladder;
• Contraindications for performing MRI or prostate biopsy in cases where PSA is over 4 ng/ml;
• Intolerance to transrectal ultrasound;
• Intolerance or allergy to local anesthetics.

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University of Pisa

Pisa, Pisa, 56126, Italy

Location

Related Publications (4)

• van Riel LAMJG, van Kollenburg RAA, Vis AN, van Leeuwen PJ, de Reijke TM, de Bruin DM, Oddens JR. Safety and Feasibility of Soractelite Transperineal Focal Laser Ablation for Prostate Cancer and Short-term Quality of Life Analysis from a Multicenter Pilot Study. Eur Urol Open Sci. 2022 Apr 2;39:48-54. doi: 10.1016/j.euros.2022.02.012. eCollection 2022 May.

  PMID: 35528781 BACKGROUND

• McVary KT, Roehrborn CG. Three-Year Outcomes of the Prospective, Randomized Controlled Rezum System Study: Convective Radiofrequency Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Urology. 2018 Jan;111:1-9. doi: 10.1016/j.urology.2017.10.023. Epub 2017 Nov 6.

  PMID: 29122620 BACKGROUND

• Patelli G, Ranieri A, Paganelli A, Mauri G, Pacella CM. Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1440-1446. doi: 10.1007/s00270-017-1662-9. Epub 2017 May 4.

  PMID: 28474112 BACKGROUND

• Pacella CM, Patelli G, Iapicca G, Manenti G, Perretta T, Ryan CP, Esposito R, Mauri G. Transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a feasibility study. Results at 6 and 12 months from a retrospective multi-centric study. Prostate Cancer Prostatic Dis. 2020 Jun;23(2):356-363. doi: 10.1038/s41391-019-0196-4. Epub 2019 Dec 11.

  PMID: 31827239 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Alessandro Zucchi, Professor

  University of Pisa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: January 27, 2025
• Study Start: January 8, 2024
• Primary Completion: July 5, 2024
• Study Completion: October 15, 2024
• Last Updated: January 27, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)