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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00890851
First received: April 29, 2009
Last updated: September 30, 2009
Last verified: April 2009
  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)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Procedure Tuna Within the Framework of a Hospitalization of Short Duration

Resource links provided by NLM:


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
Other Name: radiofrenquency prostate

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Mathieu Quintin, Department of clinical research and development
ClinicalTrials.gov Identifier: NCT00890851     History of Changes
Other Study ID Numbers: P050302
Study First Received: April 29, 2009
Last Updated: September 30, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Radiofrequency
Mini invasin surgery
Outpatient treatment
Men health

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014