Phase 4 N=181 Randomized Quadruple-blind Treatment

Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction

Ureteral Obstruction

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View on ClinicalTrials.gov: NCT01741454 ↗

Enrolled (actual)

181

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion — 1.76; 1.84; 2.02; 1.93 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tamsulosin (Drug); Tolterodine ER (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion	1.76; 1.84; 2.02; 1.93; 1.95; 2.13	—
PRIMARY Ureteral Stent Symptom Questionnaire Score	2.95; 2.91; 2.98; 2.83; 2.66; 2.89	—
PRIMARY Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion	2.46; 2.55; 2.49; 2.46; 2.39; 2.49	—
PRIMARY Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal	1.72; 1.91; 1.85; 2.14; 1.66; 1.66	—

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.

Eligibility Criteria

Inclusion Criteria

Patients with unilateral ureteral stent placement for urolithiasis

Exclusion Criteria

Pre-existing lower urinary tract symptoms
Active urinary tract infection
Contraindication to anticholinergic medication
Prior hypersensitivity or allergy to tolterodine
Patients with severe hepatic impairment (Child-Pugh Class C)
Patients with uncontrolled close (narrow) angle glaucoma
Patients with urinary retention
Current anticholinergic use
Chronic pelvic pain syndromes (e.g. acute/chronic prostatitis, interstitial cystitis)
Women who are pregnant or nursing
Under 18 years of age
Prior hypersensitivity or allergy to tolterodine
Patients with severe hepatic impairment (Child-Pugh Class C)
Patients with uncontrolled close (narrow) angle glaucoma
Patients with urinary retention
Unable to provide informed consent

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Data sourced from ClinicalTrials.gov (NCT01741454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.