Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract

November 15, 2007 updated by: Fredericia Hosptial
The purpose of the study is to examine the effect of endoluminally administrated isoproterenol on pelvic pressure increase during flexible ureterorenoscopy in 14 humans. We propose that isoproterenol has potential of reducing intrarenal pressure during ureterorenoscopies. Lower intrarenal pressures may have the advantage of facilitating the procedure and reducing intraoperative complications as bleeding and infections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Fredericia, Denmark, 7000
        • Dp. of Urology, Fredericia & Kolding Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indication for ureterorenoscopy
  • Age> 18 years
  • Normal blood pressure

Exclusion Criteria:

  • Malignant disease in the upper urinary tract
  • Heart disease
  • Allergy to Isoproterenol
  • Use of α-blocking or β-blocking medicine
  • Use of Calcium-antagonists
  • Use of NSAIDs the last 48 hours
  • Present stone or JJ-stent in the ureter
  • Neurologic disease in the bladder
  • Pregnancy
  • Nursing mothers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Saline irrigation
Drug: Isoproterenol
ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation
Active Comparator: 2
ISO irrigation
Drug: Isoproterenol
ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
pelvic pressure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fredericia Hosptial

Investigators

  • Study Director: Palle JS Osther, PhD, MD, Dp. of Urology, Fredericia & Kolding Hospitals, Fredericia, denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 29, 2007

First Submitted That Met QC Criteria

January 29, 2007

First Posted (Estimate)

January 30, 2007

Study Record Updates

Last Update Posted (Estimate)

November 16, 2007

Last Update Submitted That Met QC Criteria

November 15, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HJ2
  • EudraCT nummer: 2006-005756-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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