- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03614052
Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy
Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Endoscopic treatment of urolithiasis has increased during the last several years. Adrenergic receptors have been described mainly in the distal ureter. Blockage of adrenergic receptors has been associated to a decrease in ureteral resistance. In this study the investigators hypothesized that alpha blockers are associated to a decrease in ureteral resistance with an increase in successful endoscopic management of urolithiasis.
Only patients with urolithiasis undergoing to endoscopic treatment are offered to participate. Patients are randomized between placebo arm or tamsulosin 0.4 mg/day. Demographic characteristics, stones characteristics and information related to surgery are recorded. Main study outcome is stone free rate and successful insertion of semirigid ureteroscope 8,0 - 9,8 Fr. All patients are follow-up for 30 days after surgery.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Metropolitana
-
Santiago, Metropolitana, Chile
- Hospital Clínico Pontificia Universidad Católica de Chile
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with urolithiasis undergoing to endoscopic ureterolithotomy
Exclusion Criteria:
Patients with previous ureteral catheter
- Patients with allergy to tamsulosin
- Patients currently in treatment with tamsulosin for other disease different than ureterolithiasis
- Multiple ureterolithiasis
Patients with impairment of their mental status
- Patients with open surgeries in the affected ureter or urinary diversion
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: tamsulosin hydrochloride
Tamsulosin hydrochloride 0,4 mg tablets by mouth per day for 5 days before ureteroscopy
|
Tamsulosin hydrochloride 0,4mg for 5 days before ureteroscopic treatment of urolithiasis
Other Names:
|
Placebo Comparator: Placebo oral tablet
Placebo oral tablets by mouth per day for 5 days before ureteroscopy
|
Placebo oral tablet 1 tablet per day for 5 days before ureteroscopic treatment of urolithiasis
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
stone free rate
Time Frame: 30 days
|
stone free rate after ureteroscopic management of urolithiasis
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
failed ureteroscopy rate
Time Frame: 05 days
|
failed ureteroscopy insertion in patient with urolithiasis secondary to a non accommodating ureter
|
05 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gaston Astroza, MD, Pontificia Universidad Catolica de Chile
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Pathological Conditions, Anatomical
- Ureteral Diseases
- Urinary Calculi
- Urolithiasis
- Calculi
- Ureteral Calculi
- Ureterolithiasis
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Urological Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Tamsulosin
Other Study ID Numbers
- 171229002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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