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

• Sponsor: Fredericia Hosptial (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00323843
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Kidney Stone; Ureteroscopy	Drug: Isoproterenol	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: RIRS - A Method of Treating the ESWL Resistant Kidney Stone
• Study Start Date: Jun 1, 2006
• Study Completion Date: Feb 1, 2007

Outcome Measures

Primary Outcome Measures

1. Renal pelvic pressure []

Secondary Outcome Measures

1. Blood pressure []

2. Pulse []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Dpt. of Urology	Fredericia	Vejle Council	Denmark	7000

Sponsors and Collaborators

• Fredericia Hosptial

Investigators

• Principal Investigator: Helene U Jung, Fredericia Hospital, Dpt. of Urology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00323843
• Other Study ID Numbers: 2005-005972-34
• First Posted: May 10, 2006
• Last Update Posted: Jan 30, 2007
• Last Verified: Jan 1, 2007

• Keywords provided by , ,: Kidney stone; ureteropyeloscopy; renal pelvic pressure
• Additional relevant MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi; Isoproterenol

Study Results

No Results Posted as of Jan 30, 2007