Optic fiber of 300um will be inserted at a distance of 8-10mm from the urethra. Each ablation lasts 6 minutes. Each fiber ablates at an energy of 1800J with a power of 2-3W. Treatment lasts for about 30 minutes.

Benign Prostatic Hyperplasia

Lower Urinary Tract Symptoms

The intervention will take place in an ambulatory setting of the interventional radiology department using the combined Echolaser XVG system. The treatment consists of a local anesthesia to the perineal region. Within each needle, an optic fiber of 300um will be inserted. Each ablation lasts 6 minutes and each fiber ablates1800J at a power of 2-3W. At the end of the ablation there is a pull-back of about 1cm from the original ablation location. According to the dimension of the middle lobe of the prostate, multiple pullbacks can be used. The total ablation is 3600J for 2 fibers (1800J/ fiber) at the power of 2-3W for a total duration of about 30minutes. At the end of the treatment, a 20mg bolus of i.v. corticosteroid is given for anti-edema and anti-inflammatory effects. Antibiotic therapy (Ciprofloxacin 500mg and gastroprotective therapy is given for 5 days. After an adequate amount of time for observation, the patient is dismissed.

Transperineal Focal Laser Ablation (TPLA)

Policlinico Tor Vergata (PTV) Foundation: UOC Department of Diagnostic Imaging and Interventional Radiology

Focal Laser Ablation for Benign Prostatic Hyperplasia

Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study

Improvement of obstructive symptomatology correlated to BPH. The evaluation will be based on urodynamic studies of Qmax, post void and residual volume.

Evaluation of complications post TPLA treatment by MRI.

Evaluation of multi-parametric MRI of the prostate to quantify and/or preview coagulative necrosis after treatment and evaluate the response to transperineal laser ablation treatment for lower urinary tract symptoms.

Calculation and stratification of prodecural costs in in comparison to transurethral resection of the prostate (TURP).

Evaluation of quality of life quantified by the questionnaire (IPSS)

Evaluation of Quality of Life by International Index of Erectile Function (IIEF)

Create an international registry to assess long-term effectiveness of transperineal laser ablation for lower urinary tract symptoms, to assess functional outcomes, to assess safety, to determine baseline patient characteristics, to collect information on possible differences between centres applying treatment of transperineal laser ablation and to explore the optimal treatment indications and possible limitations. It an international prospective observational registry in which data is recorded of patients who are treated with transperineal laser ablation for lower urinary tract symptoms.

Guglielmo Manenti

Principal Investigator

University of Rome Tor Vergata

rifaximin 400mg taken 3 times a day
Rifaximin (Xifaxan)

Rifaximin Treatment Arm

vancomycin 125mg taken 4 times a day
Vancomycing

Vancomycin Comparator Arm

Total

Sex: Female, Male

Race (NIH/OMB)

Resolution or improvement of baseline signs and symptoms was assessed as
Absence of severe abdominal pain for 2 consecutive days at the test of cure (TOC) Visit (Day 14 +/-1);
Absence of fever (< 38°C/100.4°F) for 2 consecutive days at the TOC Visit; and
3 unformed (loose or watery) stools per day for at least 48 hours that was sustained through the TOC Visit.

vancomycin 125mg taken 4 times a day
Vancomycin

Proportion of Participants Achieving Clinical Success, Where Clinical Success is Defined as Resolution or Improvement of Baseline Signs and Symptoms i.e., Abdominal Pain, Fever, Diarrhea.

Recurrence of CDAD was defined as diarrhea and a positive Clostridium difficile stool toxin assay that occurs after initial clinical success.

Proportion of Participants Recurrence-free of Clostridium Difficile-associated Diarrhea (CDAD), After Achieving Clinical Success

Overall Study

Director of Clinical Operations

Clostridium Infections

Diarrhea

Rifaximin (Xifaxan)

Vancomycin

Mayo Clinic Scottsdale

Inland Empire Digestive & Liver Diseases

Gastroenterology of the Rockies

Connecticut Gastroenterology Institute

The George Washington University Medical Center

Halifax Medical Center

Advanced Medical Research Center

Webster Surgical Center LLC

Digestive Healthcare of Georgia

Southeast Regional Research Group

Sky Blue, M.D.

Howard Brown Health Center

The University of Chicago

Gastroenterology, Ltd.

Springfield Clinic

Memorial Medical Center

Carle Clinic Association NCW5

Iowa Digestive Disease Center, PC

GI Specialists

Gastrointestinal Associates

Kansas Medical Clinic

Baltimore VA Medical Center

University of Maryland

Chevy Chase Clinical Research

Center for Clinical Research at Washington County Hospital

Shah Associates

Henry Ford Hospital

Arnold Markowitz, MD, PC

Newland Medical Association

St. Mary's/Duluth Clinic Health System

Minneapolis VAMC

Infectious Disease - Minneapolis Ltd.

Mayo Clinic Rochester

Digestive Health Specialists, PA

Deaconess Billings Clinic Research

Infectious Diseases Associates, PC

Dartmouth Hitchcock Medical Center

Drs. Scherl, Chessler, Zingler, Spinnel and Meininger

Marlboro Gastroenterology PC

St. Michael's Medical Center

Institute for Clinical Research (ICR) at Holy Name Hospital

The Gastroenterology Group of South Jersey

Brookdale University Hospital and Medical Center

AMS Clinical Research

North Shore Hepatology

Weill Medical College

University of Rochester School of Medicine

New York Medical College/Westchester Medical Center

East Carolina Gastroenterology, PA

Southern Gastroenterology Associates

University of Cincinnati

Regional Infectious Diseases - Infusion Center

Lima Memorial Health System

Lehigh Valley Hospital

Drexel University College of Medicine

RPS Infectious Diseases

University Gastroenterology

Digestive Disease Associates of Dallas

Michael E. DeBakey VA Medical Center

University of Texas Health Sciences Center

Infectious Disease Associates of Central Virginia

North Pacific Clinical Research

Associated Physicians, LLP

A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

A Double-Blind, Randomized, Controlled Trial of Rifaximin Compared to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

Bausch Health Americas, Inc.

azotemia

حمى

fever

azotemia/حمى

Focal Laser Ablation for Benign Prostatic Hyperplasia

A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

قاعدة بيانات الأعشاب الطبية الأكثر اكتمالا التي يدعمها العلم