Procedure Transurethral Needle Ablation (TUNA) and Hospitalization of Short Duration
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      The TUNA is a known and already old technique. There exists, in the literature, a certain
      number of studies showing the long-term effectiveness (5 years), evaluated on the IPS and the
      flow mictional.This effectiveness is slightly lower than that of the endoscopic resection of
      prostate. This technique does not present the disadvantages of the surgery prostate sufferer
      on ejaculation. Moreover, it can be carried out in short hospitalization or ambulatory as it
      is the case in particular in the States Unis. The aim of the study which will be led by the
      AP-HP will be thus to test the feasibility of the TUNA during a hospitalization of less 24
      hours.
    

Detailed description: 
      The TUNA is a known and already old technique. There exists, in the literature, a certain
      number of studies showing the long-term effectiveness (5 years), evaluated on the IPS and the
      flow mictional. This effectiveness is slightly lower than that of the endoscopic resection of
      prostate. This technique does not present the disadvantages of the surgery prostate sufferer
      on ejaculation. Moreover, it can be carried out in short hospitalization or ambulatory as it
      is the case in particular in the States Unis. The aim of the study which will be led by the
      AP-HP will be thus to test the feasibility of the TUNA during a hospitalization of less the
      24h.

      Objective one: To test the feasibility of a procedure TUNA at the time of a hospitalization
      of less 24h.

      Number of patients: A sample of N=70 patients will make it possible to estimate the frequency
      of success with a precision of ± 10% for any frequency higher than 75%.

      Analyse statistical: Principal analyze: Count held of the aim of the study the principal
      analyses will be descriptives. For the variables qualitative or semi-quantitative bilateral
      the confidence frequencies and their interval at 95% (IC95) will be presented. If the
      conditions of use of the asymptotic estimators would not be filled, of the exact estimators
      will be used. For the quantitative averages and IC95%, median variables and outdistances
      interquartile will be calculated. Together analyses will be presented for the general
      population and by center.

      Secondary analyze: In case of rate of important failure, an exploratory analysis at end of
      identification of the predictive factors of failure will be made by analysis in multivariate
      logistic regression.

      Awaited results: The precise evaluation carried out by the present study will make it
      possible to evaluate the benefit report/ratio risks in the short run procedure and its
      feasibility within the framework of a hospitalization in surgery ambulatory. The implications
      are important. Indeed, if this technique can be done into ambulatory with a high rate of
      success, then this technique of treatment could be proposed in alternative of the medical
      treatment or to the bad responders with the medical treatments.
    

Intervention name(s): Transurethral Needle Ablation (TUNA)
Intervention type(s): Procedure
Intervention description(s): Transurethral needle ablation of benign prostatic hyperplasia by radio frequencies
Other intervention name(s): radiofrenquency prostate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Radiofrequency; Mini invasin surgery; Outpatient treatment; Men health