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Trial of Tadalafil, Tamsulosin and Combination for Access Sheath Deployment

Phase 4

Waitlist Available

Led By Jaime Landman, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this will be assessed immediately post-op as well as 3 months post-op.

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing whether using an alpha blocker or a phosphodiesterase inhibitor, alone or in combination, can help patients pass a larger ureteral access sheath during ureteroscopy for kidney stones.

Eligible Conditions

Kidney Stones
Kidney stones

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this will be assessed immediately post-op as well as 3 months post-op.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this will be assessed immediately post-op as well as 3 months post-op.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be assessed immediately post-op as well as 3 months post-op. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Passage of 16F Access Sheath

Secondary study objectives

Adverse events

Complications

Injury

+1 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Flomax + PlaceboActive Control1 Intervention

Patients will be prescribed Flomax 0.4Mg Capsule and given a bottle of placebo. They will be instructed to take 1 of each pill for the seven days prior to their surgery.

Group II: Cialis + PlaceboActive Control1 Intervention

Patients will be prescribed Cialis 5Mg tablet and given a bottle of placebo. They will be instructed to take 1 of each pill for the seven days prior to their surgery.

Group III: Cialis + FlomaxActive Control1 Intervention

Patients will be prescribed .4mg of Flomax and 5mg of Cialis. They will be instructed to take 1 of each pill for the seven days prior to their surgery.

Group IV: Placebo + PlaceboPlacebo Group1 Intervention

Given 2 bottles of placebo. They will be instructed to take 1 of each pill for the seven days prior to their surgery.

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