Ignite Creation Date:
2024-05-05 @ 9:28 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00890851
Status:
COMPLETED
Last Update Posted:
2009-10-01
First Post:
2009-04-29
Brief Title:
Procedure Transurethral Needle Ablation TUNA and Hospitalization of Short Duration
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation of Procedure Tuna Within the Framework of a Hospitalization of Short Duration
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPURE
Brief 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 mictionalThis 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 N70 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 reportratio 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
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 N70 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 reportratio 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None