Hôpital TENON - Service d'Urologie
Paris, 75020, France
NCT Number: NCT00890851
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.
Looking for future studies?
Notify Me45 year–85 year
Male
Interventional
Not applicable
Paris, 75020, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transurethral needle ablation of benign prostatic hyperplasia by radio frequencies
Other names: radiofrenquency prostate
Time frame: the evening of the intervention
Time frame: in the month following the intervention
Time frame: at 1 month
Time frame: at 1 month
Time frame: at 1 month
Assistance Publique - Hôpitaux de Paris
Other
Evaluation of Procedure Tuna Within the Framework of a Hospitalization of Short Duration
Acronym: EPURE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07103278
Benign Prostatic Hyperplasia, Genital Diseases
Seoul, South Korea
View Trial DetailsNCT06589154
Benign Prostatic Hyperplasia, Genital Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT07715448
Benign Prostatic Hyperplasia, Ejaculatory Dysfunction
Banī Suwayf, Beni Suef Governorate, Egypt
View Trial DetailsNCT05200065
Benign Prostatic Hyperplasia, Genital Diseases
Cairo, Cairo Governorate, Egypt
View Trial Details