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Clinical Trials/EUCTR2004-000651-42-SE
EUCTR2004-000651-42-SE
Active, not recruiting
Not Applicable

Efficacy and Safety of Intraprostatic Injection of Mepivacaine Adrenaline prior to ProstaLund Feedback Treatment in Patients with Symptomatic Benign Prostatic Hyperplasia (BPH).

ProstaLundOperations AB0 sites48 target enrollmentJune 23, 2004
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ConditionsKan mikrovågsbehandling av godartad prostataförstoring förbättras med avsende på energiåtgång och patientkomfort genom att ge en lokal injektion av bedövningsmedel(carbocain adernalin) innan behandling?
DrugsAstra Zeneca Carbocain adrenalin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kan mikrovågsbehandling av godartad prostataförstoring förbättras med avsende på energiåtgång och patientkomfort genom att ge en lokal injektion av bedövningsmedel(carbocain adernalin) innan behandling?
Sponsor
ProstaLundOperations AB
Enrollment
48
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 23, 2004
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
ProstaLundOperations AB

Eligibility Criteria

Inclusion Criteria

  • •1\.män 45 år eller äldre
  • •2\.Symptomatisk BPH
  • •3 Prostata volym åtminstone 30 ml och prostata längd åtminstone 35 mm
  • •4\. Informerat samtycke
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\. Medicinska och/eller psykologiska orsaker att inte tolerera studieproceduren.
  • •2\. Tidigare genomgången mikrovågsterapi,TUR\-P, laser prostatektomi eller någon kirurgisk behandling av prostata.
  • •3\. Tidigare strålning av bäcken eller tidigare genomgången kirurgiskt ingrepp i bäcken.
  • •4\. Tidigare uretrastriktur,blåshalskontraktur eller blås patologi.
  • •5\. Tecken på pågående prostatit
  • •6\. Misstanke om prostatacancer(patienter med PSA density \>0,15 g/l/g skall genomgå biopsi för att utesluta malignitet)
  • •7\. Misstanke om blåscancer
  • •8\. Stor median lob
  • •9\. Känd neurologisk sjukdom(ex multiple scleros,Parkinson eller stroke) eller misstanke på svinkter abnormalitet och/eller neurogen blåsa.
  • •10\. Symtomatisk UVI vid tidpunkt för behandlingen.

Outcomes

Primary Outcomes

Not specified

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