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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transurethral Needle Ablation (TUNA)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Radiofrequency, Mini invasin surgery, Outpatient treatment, Men health

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital TENON - Service d'Urologie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Procedure TUNA

Arm Description

Outcomes

Primary Outcome Measures

Left the hospital
Not hospitalized for a complication related to the intervention

Secondary Outcome Measures

Evaluation of the satisfaction of the intervention for the patient
Evaluation for the micturition of the following parameters
Evaluation of the appeared minor complications

Full Information

First Posted
April 29, 2009
Last Updated
September 30, 2009
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00890851
Brief Title
Procedure Transurethral Needle Ablation (TUNA) and Hospitalization of Short Duration
Acronym
EPURE
Official Title
Evaluation of Procedure Tuna Within the Framework of a Hospitalization of Short Duration
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Radiofrequency, Mini invasin surgery, Outpatient treatment, Men health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Procedure TUNA
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Transurethral Needle Ablation (TUNA)
Other Intervention Name(s)
radiofrenquency prostate
Intervention Description
Transurethral needle ablation of benign prostatic hyperplasia by radio frequencies
Primary Outcome Measure Information:
Title
Left the hospital
Time Frame
the evening of the intervention
Title
Not hospitalized for a complication related to the intervention
Time Frame
in the month following the intervention
Secondary Outcome Measure Information:
Title
Evaluation of the satisfaction of the intervention for the patient
Time Frame
at 1 month
Title
Evaluation for the micturition of the following parameters
Time Frame
at 1 month
Title
Evaluation of the appeared minor complications
Time Frame
at 1 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand LUKACS, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital TENON - Service d'Urologie
City
Paris
ZIP/Postal Code
75020
Country
France

12. IPD Sharing Statement

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

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