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Relaxation of the ureter during examination of the upper urinary tract

Relaxation of the ureter during ureterorenoscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-001924-37-DK
Enrollment
Unknown
Registered
2013-11-05
Start date
2013-11-05
Completion date
Unknown
Last updated
2014-10-27

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

Conditions

Elevated pressure in the upper urinary tract during ureterorenoscopy MedDRA version: 14.1 Level: LLT Classification code 10023436 Term: Kidney stone System Organ Class: 100000004857

Interventions

Product Name: isoprenalin Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: ISOPRENALINE CAS Number: 7683-59-2 Current Sponsor code: Sponsor code not known Ot

Sponsors

Fredericia Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Denmark

Contacts

Public ContactUrological Research Center

Fredericia Hospital

helenejung@hotmail.com4528599120

Outcome results

None listed

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