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

• Sponsor: Fredericia Hosptial (Other)
• Overall Status: Completed
• CT.gov ID: NCT00428428
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone; Unexplained Haematuria; Benignant Tumour Mass in the Upper Urinary Tract	Drug: Isoproterenol	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract
• Study Start Date: Feb 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. pelvic pressure []

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dp. of Urology, Fredericia & Kolding Hospitals	Fredericia		Denmark	7000

Sponsors and Collaborators

• Fredericia Hosptial

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00428428
• Other Study ID Numbers: HJ2; EudraCT nummer: 2006-005756-32
• First Posted: Jan 30, 2007
• Last Update Posted: Nov 16, 2007
• Last Verified: Nov 1, 2007

• Keywords provided by , ,: kidney stone; ureteroscopy
• Additional relevant MeSH terms: Kidney Calculi; Nephrolithiasis; Hematuria; Isoproterenol

Study Results

No Results Posted as of Nov 16, 2007