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

Primary Purpose

Kidney Stone, Unexplained Haematuria, Benignant Tumour Mass in the Upper Urinary Tract

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Isoproterenol

About this trial

This is an interventional treatment trial for Kidney Stone focused on measuring kidney stone, ureteroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Dp. of Urology, Fredericia & Kolding Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Saline irrigation

ISO irrigation

Outcomes

Primary Outcome Measures

pelvic pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT00428428

First Posted

January 29, 2007

Last Updated

November 15, 2007

Sponsor

Fredericia Hosptial

1. Study Identification

Unique Protocol Identification Number

NCT00428428

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Fredericia Hosptial

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Stone, Unexplained Haematuria, Benignant Tumour Mass in the Upper Urinary Tract

Keywords

kidney stone, ureteroscopy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Saline irrigation

Arm Title

Arm Type

Active Comparator

Arm Description

ISO irrigation

Intervention Type

Drug

Intervention Name(s)

Isoproterenol

Intervention Description

ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation

Primary Outcome Measure Information:

Title

pelvic pressure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Palle JS Osther, PhD, MD

Organizational Affiliation

Dp. of Urology, Fredericia & Kolding Hospitals, Fredericia, denmark

Official's Role

Study Director

Facility Information:

Facility Name

Dp. of Urology, Fredericia & Kolding Hospitals

City

Fredericia

ZIP/Postal Code

7000

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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