Clinical trial NCT00890851: Procedure Transurethral Needle Ablation (TUNA) and Hospitalization of Short Duration
Official title: Evaluation of Procedure Tuna Within the Framework of a Hospitalization of Short Duration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Radiofrequency
Mini invasin surgery
Outpatient treatment
Men health
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-04-30
Enrollment: 53
Sex: MALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Man whose age is superior or egal to 45 and inferior or egal to 85 years
2. Patient presenting an anaesthetic risk of ASA 1 at 3
3. Patient accepting the protocol, in particular the return to residence with a sounder
4. 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
5. 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.
6. Patient having a residue post mictional lower than 200cc.
7. Patient presenting a normal renal function
8. Patient having a result PSA £ 4 ng/ml, or negative biopsies if PSA \> 4 and \< 10 ng/ml
9. Patient having given his free and in writing lit assent
10. Patient affiliated to the Social security or an assimilated mode
11. Patient having stopped his treatment by 5 alpha reductase since at least a month (1)

Exclusion Criteria:

1. Patient presenting a urinary infection
2. Patient presenting an acute retention of urine
3. Patient presenting a neurological bladder and/or of an anomaly of the sphincter
4. Patient currently under anticoagulant treatment.
5. Patient currently under anti-inflammatory treatment.
6. Patient presenting an affection or a confirmed or suspected malignant tumour of the prostates or vegie.
7. Patient presenting an antecedent of surgery prostatic
8. Patient presenting of the biopsies prostate sufferers carried out less than 4 months before procedure TUNA
9. 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,
10. Patient presenting a prosthesis in the zone being able to be affected by the procedure
11. Patient presenting a desire of fertility
12. Patient presenting an anorectal pathology
13. Patient presenting an allergy to the anaesthesia locale
14. Patient whose follow-up seems incompatible with the needs for the study

Primary outcomes:
measure: Left the hospital
timeFrame: the evening of the intervention
measure: Not hospitalized for a complication related to the intervention
timeFrame: in the month following the intervention
Secondary outcomes:
measure: Evaluation of the satisfaction of the intervention for the patient
timeFrame: at 1 month
measure: Evaluation for the micturition of the following parameters
timeFrame: at 1 month
measure: Evaluation of the appeared minor complications
timeFrame: at 1 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital TENON - Service d'Urologie
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Bertrand LUKACS, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: