Overview

This trial is active, not recruiting.

Condition ureteral obstruction
Treatments tamsulosin, tolterodine er
Phase phase 4
Sponsor University of Wisconsin, Madison
Start date November 2012
End date May 2017
Trial size 106 participants
Trial identifier NCT01741454, 2012-0279

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 investigators hope to show that the addition of Tolterodine ER to Tamsulosin will provided added benefits in reducing stent symptoms in patients who have had unilateral placement of a ureteral stent.

The investigators hypothesize that combination therapy with tamsulosin and tolterodine ER will yield greater symptom relief than tamsulosin alone.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
tamsulosin Flomax (TM)
0.4 mg by mouth once per day.
(Experimental)
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.
tamsulosin Flomax (TM)
0.4 mg by mouth once per day.
tolterodine er Detrol (TM)
4 mg by mouth once a day.

Primary Outcomes

Measure
Ureteral stent symptom questionnaire score
time frame: Up to 24 hours prior to stent insertion
Ureteral stent symptom questionnaire score
time frame: 42-48 hours post-stent insertion
Ureteral stent symptom questionnaire score
time frame: 5 days post-stent insertion
Ureteral stent symptom questionnaire score
time frame: Up to 24 hours after stent removal. Removal will occur 5 to 7 days after insertion.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with unilateral ureteral stent placement for urolithiasis Exclusion Criteria: 1. Pre-existing lower urinary tract symptoms 2. Active urinary tract infection 3. Contraindication to anticholinergic medication 1. Prior hypersensitivity or allergy to tolterodine 2. Patients with severe hepatic impairment (Child-Pugh Class C) 3. Patients with uncontrolled close (narrow) angle glaucoma 4. Patients with urinary retention 4. Current anticholinergic use 5. Chronic pelvic pain syndromes (e.g. acute/chronic prostatitis, interstitial cystitis) 6. Pregnant females 7. Under 18 years of age 8. Prior hypersensitivity or allergy to tolterodine 9. Patients with severe hepatic impairment (Child-Pugh Class C) 10. Patients with uncontrolled close (narrow) angle glaucoma 11. Patients with urinary retention 12. Unable to provide informed consent

Additional Information

Official title Combination Versus Monotherapy With Alpha Blocker and Anticholinergics to Relieve Urinary Stent Symptoms
Principal investigator Stephen Nakada, MD
Description The investigators aim to show that the addition of Tolterodine ER to Tamsulosin will provide added benefits in ameliorating stent related symptoms in patients who have had unilateral placement of a ureteral stent for urolithiasis. This objective will be assessed by determining the mean difference in the urinary symptom index domain of the Urinary Stent Symptom Questionnaire, which is a validated tool used to assess stent symptoms1. The investigators felt that a 15% further decrease in the index score in the experimental group, compared to the control group would represent a clinically significant improvement in urinary symptoms, based on the prior studies evaluating lower urinary tract symptoms in patients with stents. The investigators hypothesize that combination therapy with Tamsulosin and Tolterodine ER will yield greater symptom relief than tamsulosin alone.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.