Procedure Transurethral Needle Ablation (TUNA) and Hospitalization of Short Duration (EPURE)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Procedure Tuna Within the Framework of a Hospitalization of Short Duration|
- Left the hospital [ Time Frame: the evening of the intervention ] [ Designated as safety issue: No ]
- Not hospitalized for a complication related to the intervention [ Time Frame: in the month following the intervention ] [ Designated as safety issue: No ]
- Evaluation of the satisfaction of the intervention for the patient [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
- Evaluation for the micturition of the following parameters [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
- Evaluation of the appeared minor complications [ Time Frame: at 1 month ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||March 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Procedure: Transurethral Needle Ablation (TUNA)
Transurethral needle ablation of benign prostatic hyperplasia by radio frequencies
Other Name: radiofrenquency prostate
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890851
|Hôpital TENON - Service d'Urologie|
|Paris, France, 75020|
|Principal Investigator:||Bertrand LUKACS, MD,PhD||Assistance Publique - Hôpitaux de Paris|