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

Patients receive ciprofloxacin PO BID for 2 weeks.

Patients receive placebo PO BID for 2 weeks.

Prostate Cancer

ciprofloxacin

placebo

quality-of-life assessment

laboratory biomarker analysis

Veterans Administration Medical Center.

Comprehensive Cancer Center of Wake Forest University

Ciprofloxacin Compared to Placebo in Diagnosing Prostate Cancer in Patients Undergoing Prostate Biopsy

A Phase II, Double-Blind, Placebo-Controlled Prospective Randomized Clinical Trial Evaluating the Role of an Empiric 2-Week Course of Ciprofloxacin on Rates of Detection of Cancer by Prostate Biopsy in Men With Abnormal Serum Prostate Specific Antigen Found at Screening (PREP Trial)

Will be compared between groups using a binomial test to compare rates in the two groups. Groups will also be compared using logistic regression models to adjust for any pre-treatment patient level characteristics.

The data will be analyzed on a logarithmic scale to stabilize the variance. The change in log PSA from randomization to biopsy will be compared between the two groups using a two-sample t-test. In addition, the baseline log PSA levels will be compared between the two groups and if they are found to be imbalanced a 1-way analysis of covariance will be used to compare groups by including the baseline pre-randomization log-PSA value as the covariate in the model.

Will be compared between groups using Chi-square tests (or Fisher's Exact tests if the expected cell counts are below 5).

In order to determine if BPH or erectile dysfunction are associated with abnormal PSA or prostatic inflammation reported in the biopsy specimen, 2x2 Chi Square tests will be used where each measure will be dichotomized. In addition, the consistency of these associations across the two treatment groups will be examined using a 3-way table and examining the Breslow Day test to see whether the odds ratios for each treatment are comparable.

In order to determine the correlation between change in PSA from randomization to biopsy and urinalysis pre- and post-ciprofloxacin, the Pearson correlations of the change in PSA with white blood cells pre- and post-ciprofloxacin vs. placebo will be estimated. If the data is found to be non-normal the Spearman rank correlations will be used for this analysis.

The correlation between change in PSA and prostate massage pre- and post-ciprofloxacin vs placebo will be determined. Will examine whether there is a significant difference in PSA changes between the ciprofloxacin group and placebo group for different prostate massage outcomes using a 2-way analysis of variance (ANOVA) model. Will consider creating contrasts within the ANOVA model to test whether there is an ordered (possibly linear) relationship between levels of prostate massage and PSA change values (i.e., fitting a one-degree of freedom contrast within the ANOVA models).

In order to determine the qualitative and quantitative difference in flora obtained from rectal swab pre- and post- two week course of ciprofloxacin vs. placebo 2-sample t-tests will be used to compare the change in these measures (for quantitative measures) and 2x2 Chi-Square tests to examine qualitative changes (Improve Yes/no by treatment group).

To assess the correlation between prostate symptom severity (IPSS) and erectile function (IIEF-5) at baseline to ciprofloxacin or placebo treatment, an analysis of covariance model will be fit that examines the follow-up measure (IPSS) as the outcome, with the treatment indicator and IIEF-5 measure as predictors and their interaction included to see if the relationship depends on treatment.

In order to correlate urinary, prostate massage or rectal swab findings to pathology findings including cancer, inflammation, prostatic intra-epithelial neoplasia, atypical acinar proliferation or other findings will either estimate Pearson or Spearman correlations (depending on the distribution of the measures) or one measure is binary (i.e., cancer yes/no) then will examine 2-sample t-tests.

prostatic hyperplasia/kuume

Focal Laser Ablation for Benign Prostatic Hyperplasia

Ciprofloxacin Compared to Placebo in Diagnosing Prostate Cancer in Patients Undergoing Prostate Biopsy

The Efficacy of Alpha-blockers for Expulsion of Distal Ureteral Stones

Täydellisin lääketieteellinen tietokanta tieteen tukemana