Comparative Efficacy of Trans-Perineal Laser Ablation Vs Water Vapor Ablation for Benign Prostatic Hyperplasia: a Single Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Improvement of Urodynamics parameters after 3 and 12 Months of Follow up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Transperineal Laser Ablation
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.
干预措施: Transperineal laser Ablation (Procedure)
Rezum Vapor Therapy
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.
干预措施: Rezum Vapor Therapy (Procedure)
结局指标
主要结局
Improvement of Urodynamics parameters after 3 and 12 Months of Follow up
时间窗: 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 International Prostate Symptoms Score
时间窗: 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.
Improvement in post voided residual
时间窗: 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.
次要结局
- sexual outcomes(up to 12 months)
- Postoperative complications(up to 3 months)
- Prostate Specific Antigen (PSA) value(up to 12 months)
研究者
ALESSANDRO ZUCCHI
Professor
University of Pisa