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

Fredericia Hosptial

Status and phase: Completed; Phase 3; Phase 2

Conditions: Benignant Tumour Mass in the Upper Urinary Tract; Kidney Stone; Unexplained Haematuria

Treatments: Drug: Isoproterenol

Study type: Interventional

Funder types: Other

Identifiers

NCT00428428

HJ2

EudraCT nummer: 2006-005756-32

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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12 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Saline irrigation

Treatment:

Drug: Isoproterenol

2

Active Comparator group

Description:

ISO irrigation

Treatment:

Drug: Isoproterenol