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

NCT00890851 | Completed

• 1 other identifier: P050302
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Radiofrequency; Mini invasin surgery; Outpatient treatment; Men health

Outcome Measures

Primary Outcomes (2)

• Left the hospital

  the evening of the intervention

• Not hospitalized for a complication related to the intervention

  in the month following the intervention

Secondary Outcomes (3)

• Evaluation of the satisfaction of the intervention for the patient

  at 1 month

• Evaluation for the micturition of the following parameters

  at 1 month

• Evaluation of the appeared minor complications

  at 1 month

Study Arms (1)

Procedure TUNA

OTHER

Procedure: Transurethral Needle Ablation (TUNA)

Interventions

Transurethral Needle Ablation (TUNA) PROCEDURE

Transurethral needle ablation of benign prostatic hyperplasia by radio frequencies

Also known as: radiofrenquency prostate

Procedure TUNA

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital TENON - Service d'Urologie

Paris, 75020, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Bertrand LUKACS, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2009
• First Posted: April 30, 2009
• Study Start: March 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: March 1, 2009
• Last Updated: October 1, 2009

Record last verified: 2009-04

Locations

FR (1)