Relaxation of the ureter during examination of the upper urinary tract

Conditions: Elevated pressure in the upper urinary tract during ureterorenoscopy
MedDRA version: 14.1Level: LLTClassification code 10023436Term: Kidney stoneSystem Organ Class: 100000004857
Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

Registration Number: EUCTR2012-001924-37-DK

Lead Sponsor: Fredericia Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Indication for therapeutic semirigid ureterorenoscopy due to kidney stone.
Age > 18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Allergy to isoprenalin
JJ-catheter in situ
Nephrostomy in situ
Known malignancies in baldder, kidney or ureter
Pregnancy
Lactation
Disempowered
In custody

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if addition of isoprenalin in the irrigation fluid makes access to the upper urinary tract easier during ureterorenoscopy in case of a narrow ureter;Secondary Objective: Per- and post-operative complications;Primary end point(s): If addition of isoprenalin in the irrigation fluid makes it possible to pass ureter with the ureteroscope;Timepoint(s) of evaluation of this end point: during operation for kidney stone

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Per-and post-operative complications: infection and bleeding;Timepoint(s) of evaluation of this end point: During the operation and until patient is discharged from hospital