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

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT06794333
• Lead Sponsor: University of Pisa

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.

Detailed Description

Therapeutic options for the treatment of benign prostatic hyperplasia (BPH) encompass a wide range of both pharmacological and surgical approaches. BPH is an age-related condition that increasingly affects relatively younger individuals, starting from the age of 50.

Pharmacological therapy primarily involves medications that can alleviate symptoms but do not cure or lead to a regression of the prostate gland enlargement over time.

Surgical therapy aims to reduce the degree of obstruction, and in most cases, it can result in significant alterations in sexual function, such as inducing retrograde ejaculation or causing erectile dysfunction. These side effects are more common with the use of classical treatment methods, whose clinical value is widely recognized and confirmed by clinical evidence reported in international guidelines (EAU Guidelines, 2021 edition).

The classical surgical treatment methods include the removal of the adenoma (benign hyperplastic part of the prostate gland) through open surgery, transurethral resection (TURP), laser ablation with en bloc removal (holmium and thulium lasers), or direct cavitation (green light laser). These classical methods typically require hospital admission with a stay of three days or more, depending on the extent of postoperative bleeding and the risk of post-surgical obstructive complications (bladder clots).

On the other hand, some minimally invasive and innovative methods can reduce the symptoms caused by the disease while preserving the patient's sexual function. These techniques also allow for treatment without hospitalization or, at most, in a outpatients setting, utilizing local anesthesia or sedation and presenting a low risk of bleeding or other complications. Specifically, the minimally invasive technologies aim for thermal ablation of the hyperplastic tissue without cavitation. This approach results in longer healing times and clinical improvement, as they are dependent on cellular apoptosis, tissue necrosis, and spontaneous gland remodeling, which occur in the months following treatment, thus not producing immediate visible or effective results.

These methods include Rezum (WVA), I-Tind, and SoracteLite trans-perineal laser ablation (TPLA). All of these minimally invasive methods have been extensively validated by clinical studies and scientific evidence.

SoracteLite-TPLA increases the temperature of the treated tissue through the absorption of laser radiation delivered to the targeted tissue by very thin optical fibers inserted perineally. Exposure to high temperatures causes coagulative necrosis of the tissues. In contrast, WVA involves the transurethral injection of water vapor through a radiofrequency needle. The local temperature increase generated by radiofrequency and water vapor leads to progressive tissue necrosis, reducing the size of the prostate adenoma and significantly improving urinary flow.

It is also logical that the use of minimally invasive methods allows for treating a larger number of patients with a lower risk of complications, although with an apparently reduced effectiveness in deobstruction compared to classical methods. The economic and social advantages are further highlighted by the faster resolution of waiting lists and greater psychological acceptance by the patient, due to the preservation of certain sexual functions and the reduced personal burden associated with the complex system of hospitalization/anesthesia/surgery/outcomes.

The primary objective is to evaluate the efficacy of TPLA vs WVA treatment at 3, 6, and 12 months in patients with BPH in terms of improvement in uroflowmetry parameters and symptoms. Specifically, the uroflowmetry parameters analyzed include maximum flow (Qmax), average flow (Qmed), and post-void residual (PVR). For symptom assessment, the IPSS questionnaire will be used.

The secondary objective includes evaluating the impact of these methods on the sexual health of treated participants through the IIEF5 and MSHQ-EJ questionnaires, which will be administered at 3, 6, and 12 months.

All participants will therefore undergo follow-up at 3, 6, and 12 months, during which they will undergo uroflowmetry with recording of Qmax, Qmed, and PVR parameters, as well as administration of the IPSS, IIEF5, and MSHQ-EJ questionnaires. This is a single-center randomized clinical trial in which participants are randomized 1:1 into the two treatment arms by the researchers.

Study Timeline

• Study Start: 2024-01-08
• Status Verified: 2024-05
• Primary Completion: 2024-07-05
• Study Completion: 2024-10-15
• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement of Urodynamics parameters after 3 and 12 Months of Follow up	up to 12 months	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.
Improvement in post voided residual	up to 12 months	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.
Improvement in International Prostate Symptoms Score	up to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	up to 3 months	Evaluate the incidence of postoperative complications according to Calvin Dindo Classification.; The Clavien-Dindo classification categorizes complications related to a surgical procedure on a scale from 1 to 5. The severity of the complication increases with higher Clavien-Dindo scores.
Prostate Specific Antigen (PSA) value	up to 12 months	To evaluate the PSA levels at 3,6 and 12 months. PSA will be reported by combining nanograms and milliliters (ng/ml).
sexual outcomes	up to 12 months	To assess the impact of the procedures on anterograde ejaculatory function, we will use the Male Sexual Health Questionnaire - Ejaculation Disfunction (MSHQ-EJD).; Higher scores reflect better ejaculatory function, with the questionnaire ranging from 0 to 15. Additionally, a final question, scored from 0 to 5, assesses the difficulty experienced by the patient during ejaculation. For this specific question, higher scores correspond to greater levels of difficulty reported (0: no difficulty, 5: extremely bothered).

Trial Locations

Locations (1)

University of Pisa; 🇮🇹 Pisa, Italy