Retrograde Intrarenal Stone Surgery - A Method of Treating the ESWL Resistant Kidney Stone

This study is ongoing, but not recruiting participants.

Sponsored by:	Fredericia Hosptial
Information provided by:	Fredericia Hosptial
ClinicalTrials.gov Identifier:	NCT00323843

Purpose

Is it possible to decrease the intrarenal pressure in the kidney during endoscopic management of kidney stone by topical administration of drugs? In order to secure fewer complications in ureteroscopic operations the pharmacological agent isoproterenol is tested on pigs and human to determine its potential of lowering intrarenal pressure.

Condition	Intervention	Phase
Kidney Stone Ureteroscopy	Drug: Isoproterenol	Phase II

Drug Information available for: Isoproterenol Isoproterenol hydrochloride Isoproterenol sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	RIRS - A Method of Treating the ESWL Resistant Kidney Stone

Further study details as provided by Fredericia Hosptial:

Primary Outcome Measures:

Renal pelvic pressure

Secondary Outcome Measures:

Blood pressure
Pulse

Estimated Enrollment:	10
Study Start Date:	June 2006
Estimated Study Completion Date:	February 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Indication for RIRS procedure
Age > 18 years
Normotensive
Capable of understanding information given

Exclusion Criteria:

Previous myocardiac infarct
Daily use of alpha- og beta- blocking medicine og calcium antagonists
Use of NSAID the last 2 days
Stone in the ureter
Declared
Known malignant disease in urinary tract
Bladder disease
Nephrostomies inserted
JJ-catheters inserted
Prisoners
Pregnant
Nursing mothers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323843

Locations

Denmark, Vejle Council
Dpt. of Urology
Fredericia, Vejle Council, Denmark, 7000

Sponsors and Collaborators

Fredericia Hosptial

Investigators

Principal Investigator:

Helene U Jung

Fredericia Hospital, Dpt. of Urology

More Information

Study ID Numbers:	2005-005972-34
Study First Received:	May 8, 2006
Last Updated:	January 29, 2007
ClinicalTrials.gov Identifier:	NCT00323843
Health Authority:	Denmark: Danish Medicines Agency; Denmark: Ethics Committee

Keywords provided by Fredericia Hosptial:

Kidney stone
ureteropyeloscopy
renal pelvic pressure

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis
Kidney Diseases

Calculi
Nephrolithiasis
Isoproterenol
Kidney Calculi

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Cardiotonic Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents

Cardiovascular Agents
Protective Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009