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

Pharmacological relaxation of the ureter when using access sheaths during ureterorenoscopy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004475-13-DK

Enrollment

Registered

2014-03-05

Start date

2014-03-05

Completion date

Unknown

Last updated

2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resistance in the ureter when inserting a ureteral access sheath during ureterorenoscopy. MedDRA version: 16.1 Level: LLT Classification code 10023436 Term: Kidney stone System Organ Class: 100000004857

Interventions

Product Name: Isoprenalin Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion INN or Proposed INN: ISOPRENALINE CAS Number: 7683-59-2 Concentration unit: mg/ml milli

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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. If insertion is successfull the intervention is over as well.	—

Measure

Time frame

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. 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. If insertion is successfull the intervention is over as well.

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Secondary

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

Countries

Denmark

Contacts

Public ContactUrological Research Center

Fredericia Hospital

Soren.Kissow.Lildal@rsyd.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026