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Alpha-1 Blocker

Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction

Phase 4

Waitlist Available

Led By Stephen Nakada, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

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

Must have

* Patients with unilateral ureteral stent placement for urolithiasis

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42-48 hours post-stent insertion

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Approved for 5 Other Conditions

No Placebo-Only Group

Drug Has Already Been Approved

Summary

The purpose of this study is to determine whether combination therapy with Tolterodine ER and Tamsulosin is more effective than monotherapy with tamsulosin alone in reducing stent symptoms. The second purpose is to determine if people have less stent discomfort if they take these medications starting 2 weeks before the stent is placed The investigators hope to show that the addition of Tolterodine ER to Tamsulosin will provide added benefits in reducing stent symptoms in patients who have had unilateral placement of a ureteral stent.

Eligible Conditions

Ureteral Obstruction

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42-48 hours post-stent insertion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42-48 hours post-stent insertion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42-48 hours post-stent insertion for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Ureteral Stent Symptom Questionnaire Score

Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion

Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal

+1 more

Awards & Highlights

All Individual Drugs Already Approved

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

Pivotal Trial

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

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Tamsulosin plus Tolterodine ER 7-day treatmentExperimental Treatment2 Interventions

Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms. Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.

Group II: Tamsulosin plus Tolterodine ER 21-day treatmentExperimental Treatment2 Interventions

Group III: Tamsulosin plus placebo 21-day treamtnetActive Control1 Intervention

Group IV: Tamsulosin plus placebo 7-day treatmentActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tolterodine

FDA approved

Tamsulosin

FDA approved

0 / 1Eligibility criteria met