Benign Prostatic HyperplasiaEPURENCT00890851
Procedure Transurethral Needle Ablation (TUNA) and Hospitalization of Short Duration
A study testing Transurethral Needle Ablation (TUNA) in people with Benign Prostatic Hyperplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Transurethral Needle Ablation (TUNA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2006to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Procedure Tuna Within the Framework of a Hospitalization of Short Duration
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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Transurethral Needle Ablation (TUNA)
- Keywords
- Radiofrequency, Mini invasin surgery, Outpatient treatment, Men health
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral Needle Ablation (TUNA)Procedure or surgery
Also called radiofrenquency prostate
Transurethral needle ablation of benign prostatic hyperplasia by radio frequencies
| Study group | Role | What they receive |
|---|---|---|
| Procedure TUNA | Other | Not described Receives: Procedure: Transurethral Needle Ablation (TUNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left the hospital
Measured: the evening of the intervention
Not hospitalized for a complication related to the intervention
Measured: in the month following the intervention
Secondary outcomes (3)
Evaluation of the satisfaction of the intervention for the patient
Measured: at 1 month
Evaluation for the micturition of the following parameters
Measured: at 1 month
Evaluation of the appeared minor complications
Measured: at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startMar 2006
- Primary completionDec 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Bertrand LUKACS, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890851
- Sponsor's protocol ID
- P050302
- Acronym
- EPURE
- Status last verified
- Apr 2009
- First submitted
- 29 Apr 2009
- Last updated
- 1 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Procedure Tuna Within the Framework of a Hospitalization of Short Duration
- ClinicalTrials.gov ID
- NCT00890851
- Acronym / sponsor ID
- EPURE / P050302
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Radiofrequency, Mini invasin surgery, Outpatient treatment, Men health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 30 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procedure TUNA | Other | Procedure: Transurethral Needle Ablation (TUNA) |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transurethral Needle Ablation (TUNA)Also: radiofrenquency prostateTransurethral needle ablation of benign prostatic hyperplasia by radio frequencies | Procedure or surgery | Procedure TUNA |
Primary outcome
Left the hospital
Time frame: the evening of the intervention
Not hospitalized for a complication related to the intervention
Time frame: in the month following the intervention
3 secondary outcomes
Evaluation of the satisfaction of the intervention for the patient
Time frame: at 1 month
Evaluation for the micturition of the following parameters
Time frame: at 1 month
Evaluation of the appeared minor complications
Time frame: at 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand LUKACS, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transurethral Needle Ablation (TUNA) in people with Benign Prostatic Hyperplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left the hospital (time frame: the evening of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2009.