Procedure Transurethral Needle Ablation (TUNA) and Hospitalization of Short Duration - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00890851

Purpose

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.

Condition	Intervention
Benign Prostatic Hyperplasia	Procedure: Transurethral Needle Ablation (TUNA)

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Procedure Tuna Within the Framework of a Hospitalization of Short Duration

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	53
Study Start Date:	March 2006
Study Completion Date:	March 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Procedure TUNA	Procedure: Transurethral Needle Ablation (TUNA) Transurethral needle ablation of benign prostatic hyperplasia by radio frequencies

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.

Eligibility

Ages Eligible for Study:	45 Years to 85 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Man whose age is superior or egal to 45 and inferior or egal to 85 years
Patient presenting an anaesthetic risk of ASA 1 at 3
Patient accepting the protocol, in particular the return to residence with a sounder
Patient presenting a TUBA related to a HBP and lasting since more than 3 months
1. with a gene score higher superior or egal to 3
2. with a score IPS superior to 8
Patient presenting a prostate whose estimated weight is inferior or egal to 80g, without median lobe prevailing and whose transverse width lies between 34 and 80 mm.
Patient having a residue post mictional lower than 200cc.
Patient presenting a normal renal function
Patient having a result PSA £ 4 ng/ml, or negative biopsies if PSA > 4 and < 10 ng/ml
Patient having given his free and in writing lit assent
Patient affiliated to the Social security or an assimilated mode
Patient having stopped his treatment by 5 alpha reductase since at least a month (1)

Exclusion Criteria:

Patient presenting a urinary infection
Patient presenting an acute retention of urine
Patient presenting a neurological bladder and/or of an anomaly of the sphincter
Patient currently under anticoagulant treatment.
Patient currently under anti-inflammatory treatment.
Patient presenting an affection or a confirmed or suspected malignant tumour of the prostates or vegie.
Patient presenting an antecedent of surgery prostatic
Patient presenting of the biopsies prostate sufferers carried out less than 4 months before procedure TUNA
Patient introducing of the antecedents of vesical lithiasis, haematuria important, contracting of the urethra, stenosis of the vesical collar, pathologies of the bladder or sweetened diabetes affecting vesical operation,
Patient presenting a prosthesis in the zone being able to be affected by the procedure
Patient presenting a desire of fertility
Patient presenting an anorectal pathology
Patient presenting an allergy to the anaesthesia locale
Patient whose follow-up seems incompatible with the needs for the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890851

Locations

France
Hôpital TENON - Service d'Urologie
Paris, France, 75020

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Bertrand LUKACS, MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Department of clinical research and development ( Mathieu Quintin )
Study ID Numbers:	P050302
Study First Received:	April 29, 2009
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00890851 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Radiofrequency
Mini invasin surgery
Outpatient treatment
Men health

Study placed in the following topic categories:

Hyperplasia
Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

Additional relevant MeSH terms:

Hyperplasia
Pathologic Processes
Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

ClinicalTrials.gov processed this record on May 07, 2009