Convective Thermal Therapy: Durable 2-Year Results of Randomized Controlled and Prospective Crossover Studies for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia.

Purpose: We report 2-year outcomes of a multicenter randomized controlled trial plus 1-year results of a crossover trial after treatment with convective radiofrequency water vapor thermal energy for lower urinary tract symptoms due to benign prostatic hyperplasia.

Materials And Methods: A total of 197 men at least 50 years old with I-PSS (International Prostate Symptom Score) 13 or greater, maximum flow rate 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 to thermal therapy with the Rezūm® System or a control group. Rigid cystoscopy with simulated active treatment sounds served as the control procedure.

Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia.

Objective: The objective of this study was to assess the effectiveness and safety of convective radiofrequency (RF) water vapor thermal therapy in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH); a pilot study design with 2-year follow-up evaluations.

Patients And Methods: Men aged ≥45 years with an International Prostate Symptom Score ≥13, a maximum urinary flow rate (Q) ≤15 mL/s, and prostate volume 20-120 cc were enrolled in a prospective, open-label pilot study using convective RF water vapor energy with the Rezūm System. Patients were followed up for 2 years after transurethral thermal treatment at 3 international centers in the Dominican Republic, Czech Republic, and Sweden.

Erectile and Ejaculatory Function Preserved With Convective Water Vapor Energy Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Randomized Controlled Study.

Introduction: Most surgical treatments for male lower urinary tract symptoms and benign prostatic hyperplasia affect erectile and ejaculatory functions negatively, leading to patient dissatisfaction.

Aim: To determine whether water vapor thermal therapy, when conducted in a randomized controlled trial, would significantly improve lower urinary tract symptoms secondary to benign prostatic hyperplasia and urinary flow rate while preserving erectile and ejaculatory functions.

Methods: Men at least 50 years old with International Prostate Symptom Scores of at least 13, a peak flow rate of at least 5 to no higher than 15 mL/s, and prostate volume of 30 to 80 cm(3) were randomized 2:1 between Rezūm System thermal therapy and control.

Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

Purpose: This report reveals the results of a multicenter, randomized, controlled study using transurethral prostate convective water vapor thermal energy to treat lower urinary tract symptoms associated with benign prostatic hyperplasia.

Materials And Methods: Men 50 years old or older with an International Prostate Symptom Score of 13 or greater, maximum flow rate of 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 between thermal therapy with the Rezūm® System and control. Thermal water vapor was injected into the transition zone and median lobe as needed.

Efficacy and Safety of Rezūm System Water Vapor Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

Objective: To assess 1-year efficacy and safety data from pilot trials of the Rezūm System water vapor to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Materials And Methods: A total of 65 men with symptoms of moderate to severe BPH were enrolled in pilot studies at centers in the Dominican Republic, the Czech Republic, and Sweden. Each patient was treated with transurethral delivery of sterile water vapor (steam).

Rezūm System Water Vapor Treatment for Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia: Validation of Convective Thermal Energy Transfer and Characterization With Magnetic Resonance Imaging and 3-Dimensional Renderings.

Objective: To evaluate by magnetic resonance imaging the physical effects of convective thermal energy transfer with water vapor as a means of treating lower urinary tract symptoms due to benign prostatic hyperplasia.

Methods: Sixty-five men with lower urinary tract symptoms were treated with the Rezūm System by transurethral intraprostatic injection of water vapor. A group of 45 of these men consented to undergo a series of gadolinium-enhanced magnetic resonance imagings of the prostate after treatment to monitor the size and location of ablative lesions, their time course of resolution, and the corresponding change in prostate tissue volume.

Transurethral convective water vapor as a treatment for lower urinary tract symptomatology due to benign prostatic hyperplasia using the Rezūm(®) system: evaluation of acute ablative capabilities in the human prostate.

Background: The purpose of this study was to assess the acute ablative characteristics of transurethral convective water vapor (steam) using the Rezūm(®) system in men with benign prostatic hyperplasia through histologic and radiographic studies.

Methods: Seven patients were treated with transurethral intraprostatic injections of sterile steam under endoscopic visualization followed by previously scheduled adenectomies. The extirpated adenomas were grossly examined followed by whole mount sectioning and staining with triphenyl-tetrazolium chloride (TTC) to evaluate thermal ablation.

Initial human feasibility study of DC ablation as a treatment for benign prostatic hyperplasia: 6 month follow-up data.

Direct current (DC) ablation is a novel non-thermal technology that causes focused coagulative necrosis in the lateral lobes of the prostate to treat benign prostatic hyperplasia (BPH). The necrosis is caused by a zone of non-physiologic pH which is created in a predictable pattern around each electrode in which a direct current is applied during treatment. The objective of this study was to optimize treatment parameters and assess treatment tolerability using transurethral DC ablation as an office-based treatment for BPH.

Characterizing Prostiva RF treatments of the prostate for BPH with gadolinium-enhanced MRI.

Transurethral needle ablation (TUNA) is an accepted and effective therapy for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Prostiva (Medtronic, Shoreview, MN) is the newest-generation device, which includes a new needle design and radio frequency (RF) generator. This device creates temperatures of 120 degrees C and necrotic lesions in less than 2.

Blood pressure surges during office-based transurethral microwave therapy for the prostate.

Objective: To investigate the occurrence of adverse blood pressure (BP) events during transurethral microwave therapy (TUMT) for benign prostatic hyperplasia.

Patients And Methods: We conducted a retrospective study of the vital signs of 185 consecutive patients who received TUMT (via 6 devices) at 4 institutions from March 1, 2003, to September 18, 2005. Maximum change, percent change in systolic BP, diastolic BP, mean arterial pressures, heart rate, and oxygen saturation were evaluated.

Characterizing TUNA ablative treatments of the prostate for benign hyperplasia with gadolinium-enhanced magnetic resonance imaging.

Background And Purpose: Transurethral Needle Ablation of the prostate TUNA has been accepted as an office-based treatment for benign prostatic hyperplasia (BPH) for many years. Clinical outcomes have been reported, but the amount and location of the necrosis produced have yet to be characterized. The necrosis caused by TUNA was evaluated by gadolinium-enhanced magnetic resonance imaging (MRI) of the pelvis.

Intraprostatic injection of alcohol gel for the treatment of benign prostatic hyperplasia: preliminary clinical results.

Benign prostatic hyperplasia (BPH) is one of the most common diseases ailing older men. Office-based procedures offer the advantage of being more effective than medications, while limiting the adverse effects, cost, and recovery of surgery. This study presents preliminary data on a new procedure that utilizes intraprostatic alcohol gel injection to ablate prostatic tissue.

Five-year follow-up of feedback microwave thermotherapy versus TURP for clinical BPH: a prospective randomized multicenter study.

Objectives: To compare the efficacy and safety of transurethral microwave thermotherapy (TUMT) with ProstaLund Feedback Treatment, using the CoreTherm device, with transurethral resection of the prostate (TURP) 5 years after treatment.

Methods: This prospective, randomized, multicenter study was conducted at 10 centers in the United States and Scandinavia. A total of 154 patients with benign prostatic hyperplasia were randomized to TUMT or TURP in a 2:1 ratio.

Interstitial temperature mapping during Prolieve transurethral microwave treatment: imaging reveals thermotherapy temperatures resulting in tissue necrosis and patent prostatic urethra.

Objectives: Temperature mapping of the prostate during transurethral microwave thermotherapy and imaging of the resultant zones of tissue necrosis have been previously performed using several commercial systems. This study was performed using the Prolieve Thermodilatation System, which simultaneously compresses the prostate with a 46F balloon circulating heated fluid and delivering microwave energy into the prostate.

Methods: Interstitial temperature mapping during Prolieve treatment was performed on 10 patients with benign prostatic hyperplasia using 24 temperature sensors arrayed throughout the prostate.

Transurethral microwave thermotherapy effectiveness in small prostates.

Objectives: To dispel the misconceptions that patients with small prostates react differently than patients with larger prostates to cooled transurethral microwave thermotherapy. Cooled transurethral microwave thermotherapy has developed into a valid alternative to treat men with lower urinary tract symptoms due to benign prostatic hyperplasia. However, doubts still remain regarding the ability of this office-based technique to treat smaller prostates.

In vivo temperature mapping of prostate during treatment with TherMatrx TMx-2000 device: heat field and MRI determinations of necrotic lesions.

Background And Purpose: The effectiveness of any thermotherapy device is determined by the temperatures created and how long they are applied. Understanding the heating characteristics of a thermotherapy device is vital to its correct implementation. Interstitial temperature mapping was used to determine the heat field created within the prostate by the TherMatrx TMx-2000 transurethral microwave thermotherapy (TUMT) device.

Ablation of stage T1/T2 prostate cancer with permanent interstitial temperature self-regulating rods.

Purpose: To determine if stage T(1)/T(2) prostate cancer can be treated safely and effectively with interstitial thermal ablation.

Patients And Methods: Twenty patients with biopsy-confirmed prostate cancer were enrolled in the protocol. The average age was 71.

Three-year follow-up of feedback microwave thermotherapy versus TURP for clinical BPH: a prospective randomized multicenter study.

Objectives: To compare, in a prospective randomized multicenter study, the efficacy and safety of transurethral microwave thermotherapy with ProstaLund Feedback Treatment (PLFT), using the CoreTherm device, with transurethral resection of the prostate (TURP) 36 months after treatment.

Methods: The study was conducted at 10 centers in the United States and Scandinavia. A total of 154 patients with benign prostatic hyperplasia were randomized to PLFT or TURP in a 2:1 ratio.

Long-term pooled analysis of multicenter studies of cooled thermotherapy for benign prostatic hyperplasia results at three months through four years.

Objectives: To determine the long-term efficacy of cooled thermotherapy in the treatment of lower urinary tract symptoms of clinical benign prostatic hyperplasia.

Methods: A total of 541 men underwent cooled thermotherapy treatment in six multicenter studies in the United States, England, and Canada. Both fixed and random effects models were used to pool the data across the six studies.

Evaluation of microwave thermotherapy with histopathology, magnetic resonance imaging and temperature mapping.

Purpose: Interstitial temperature mapping was used to determine the heat field within the prostate by the Coretherm (ProstaLund, Lund, Sweden) transurethral microwave thermotherapy device. Gadolinium enhanced magnetic resonance imaging (MRI) and histopathology were used to determine the extent and pattern of coagulation necrosis following treatment. The cell kill assessment feature of the device was compared with MRI and histopathology.

Histological changes of minimally invasive procedures for the treatment of benign prostatic hyperplasia and prostate cancer: clinical implications.

Purpose: Benign prostatic hyperplasia (BPH) is near universal in aging men, creating tremendous costs in morbidity and surgical treatment. In the last decade numerous nonsurgical minimally invasive methods have emerged for ablation of prostatic tissue.

Materials And Methods: We reviewed the recently published English language literature on minimally invasive techniques for treating BPH and cancer with an emphasis on histopathological findings.