Pharmacological relaxation of the ureter when using access sheaths during endoscopy of the kidney

Phase 1

Conditions: Resistance in the ureter when inserting a ureteral access sheath during ureterorenoscopy.
MedDRA version: 16.1Level: LLTClassification code 10023436Term: Kidney stoneSystem Organ Class: 100000004857
Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

Registration Number: EUCTR2013-004475-13-DK

Lead Sponsor: Fredericia Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 22

Inclusion Criteria

Indication for diagnostic og therapeutic flexible ureterorenoscopy, and expected use of access sheath.
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

Allergy to isoprenalin
JJ-catheter in situ
Nephrostomy in situ
Ipsilateral ureteral stone
Known malignancies in bladder, ureter or kidney
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 isoprenaline to the irrigation fluid makes it possible to insert an access sheath in the ureter of patients were insertion was impossible because of ureteral resistance.;Secondary Objective: Assessment of peroperative lesions in the ureter.<br>Assessment of postoperative complications.;Primary end point(s): If addition of isoprenaline to the irrigation fluid makes it possible to fully insert a ureteral access sheath to the kidney in patients where this was not possible because of ureteral resistance.;Timepoint(s) of evaluation of this end point: After 1 minute of irrigation, insertion of ureteral access sheath wil be attempted. If it is not possible irrigation is repeated for 1 minute before another attempt of insertion. This is repeated max. 5 times, where after the intervention is over.<br>If insertion is successfull the intervention is over as well.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Assessment of peroperative lesions in the ureter.<br>Assessment of postoperative complications, infection or bleeding.;Timepoint(s) of evaluation of this end point: During the operation and until discharge from the hospital.