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Status:

COMPLETED

Procedure Transurethral Needle Ablation (TUNA) and Hospitalization of Short Duration

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Benign Prostatic Hyperplasia

Eligibility:

MALE

45-85 years

Phase:

NA

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.T...

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. ...

Eligibility Criteria

Inclusion

  • 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
  • with a gene score higher superior or egal to 3
  • 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

  • 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

Key Trial Info

Start Date :

March 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

53 Patients enrolled

Trial Details

Trial ID

NCT00890851

Start Date

March 1 2006

End Date

March 1 2009

Last Update

October 1 2009

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hôpital TENON - Service d'Urologie

Paris, France, 75020