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NCT03229889 · ClinicalTrials.gov registry record · Phase 4
Trial of Tadalafil, Tamsulosin and Combination for Access Sheath Deployment
A Phase 4 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 4
- Development phase
- 220
- Enrollment target
NCT03229889 is a Phase 4 study that has completed, run by University of California, Irvine. The registered enrollment target is 220 participants.
The verdict
NCT03229889, a Phase 4 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 220 participants
- Enrollment target
Study 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 keeping the hormone norepinephrine (noradrenaline) from tightening the muscles in the walls of smaller arteries and veins, which causes the vessels to remain open and relaxed. This improves blood flow and lowers blood pressure. There are studies that demonstrate alpha-blockers decrease ureteral pressure and help the ureter "relax." Recent studies have shown that phosphodiesterase inhibitors may also help with ureteral stone passing. A phosphodiesterase inhibitor is a drug that blocks an enzyme that inhibits relaxation of smooth muscle. This means that it can help smooth muscle, such as the muscle that lines the ureter, to relax. While ureteral relaxation is helpful in the passage of ureteral stones, our study seeks to use this finding by pretreating participants with an older generation alpha blocker or a phosphodiesterase inhibitor prior to passage of a ureteral access sheath in cases in which ureteroscopy is being used to approach a ureteral or renal stone. By relaxing the ureter, it is possible that a larger access sheath can be safely placed. This may allow for facilitating passage of the ureteroscope and extraction of stone fragments while precluding the development of potentially damaging intrarenal pressure from the flow of irrigant. The ureteral access sheath also protects the ureter from damage during the procedure. Placement of the largest access sheath possible is helpful in that larger stone fragments can be retrieved, the flow of irrigant is improved, and the surgical field is kept clear of blood or debris. To date, nobody has studied whether use of an uro-selective alpha blocker, alone, or in combination with a 5 phosphodiesterase inhibitor will result in passage of larger access sheaths. In this study participants will be randomized into 1 of 4 categories: F
Interventions
- DRUG Placebo
- DRUG Cialis 5Mg Tablet
- DRUG Flomax 0.4Mg Capsule
- COMBINATION_PRODUCT Cialis + Flomax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2017-06-07 |
| Est. Completion | 2022-03-24 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03229889
The ClinicalTrials.gov registry entry for NCT03229889 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03229889 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03229889 about?
NCT03229889 is a clinical study titled "Trial of Tadalafil, Tamsulosin and Combination for Access Sheath Deployment". 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 keeping the hormone norepinephrine (noradrenaline) from tightening the muscles in the walls of smaller art...
What is the current status of trial NCT03229889?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 220 participants. The study started on 2017-06-07. Estimated completion is 2022-03-24.
What interventions are being tested in trial NCT03229889?
The interventions under investigation include: Placebo (DRUG), Cialis 5Mg Tablet (DRUG), Flomax 0.4Mg Capsule (DRUG), Cialis + Flomax (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03229889?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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