Status:
UNKNOWN
Trial of Tadalafil, Tamsulosin and Combination for Access Sheath Deployment
Lead Sponsor:
University of California, Irvine
Conditions:
Nephrolithiasis
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
Extensive literature exists on the use of alpha-blocker medications for the removal of kidney stones. Alpha blockers relax certain muscles and help small blood vessels remain open. They work by keepin...
Detailed Description
Technological improvements such as the miniaturization and development dual lumen ureteroscopes have improved the urologists' ability to treat urolithiasis1. The quality of flexible ureterorenoscopy i...
Eligibility Criteria
Inclusion
- Patients undergoing percutaneous nephrolithotomy (PCNL) or ureteroscopy (URS) for renal or proximal ureteral urolithiasis
- A documented sterile urine culture within 1-2 weeks of the procedure
- ≥ 18 years old
- Ability to understand and the willingness to sign a written informed consent
Exclusion
- \- Patients \< 18-years-old
- Presence of ureteral stent or nephrostomy tube prior to scheduled procedure
- Patients requiring open, endoscopic, or laparoscopic procedure in the same setting as the intended URS or PCNL
- Planned concurrent bilateral endoscopic ureteral procedures
- Patients currently taking alpha-blockers within 14 days of surgery
- Patients taking PDE-5 inhibitors within 14 days of surgery
- Pregnant women
- Active urinary tract infection (UTI) or uncontrolled HIV
- Uncorrected coagulopathy
- Patients who cannot stop their blood thinners, and/or non-steroidal anti-inflammatory medications 5-7 days prior to the procedure
- Patients allergic to tamsulosin or tadalafil
- Patients with upcoming cataract surgery due to risk of floppy iris syndrome
- Patients with history of priapism
- Patients with hereditary retinitis pigmentosa
- Patients concurrently using nitrates for myocardial infarction (MI) or angina
- Patients with high risk cardiovascular disease: left ventricular outflow obstruction, MI in last 90 days, unstable angina, stroke in last 6 months, uncontrolled arrhythmias
- Patients with renal impairment (CrCl \< 30 mL/min) or severe hepatic impairment (Child-Pugh score ≥ 10)
- Patients using CYP3A4 inhibitors such as clarithromycin, ritonavir, ketoconazole, or Iitraconazole
Key Trial Info
Start Date :
June 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03229889
Start Date
June 7 2017
End Date
April 1 2022
Last Update
April 19 2021
Active Locations (1)
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1
UC Irvine Health
Orange, California, United States, 92868