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Study tests two drugs to improve kidney stone removal

NCT ID NCT03229889

Symptom relief Sponsor: University of California, Irvine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving tadalafil (Cialis) and/or tamsulosin (Flomax) before kidney stone surgery helps doctors place a larger tube into the ureter, which can make the procedure safer and more effective. 220 adults undergoing surgery for kidney stones were randomly assigned to receive one or both drugs or a placebo. The goal was to see if these medications relax the ureter enough to allow a bigger access sheath, potentially reducing complications and improving stone removal.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

220 people

The number who actually took part.

Started

Jun 2017

Finished

Mar 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: \- 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

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Conditions

The condition(s) this trial relates to.

nephrolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nephrolithiasis

Contacts and locations

Locations

  • UC Irvine Health

    Orange, California, 92868, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.