DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction

Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ureteral Obstruction

Intervention: Tamsulosin (Drug); Tolterodine ER (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University of Wisconsin, Madison

Official(s) and/or principal investigator(s):
Stephen Nakada, MD, Principal Investigator, Affiliation: Univeristy of Wisconsin

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.

Clinical Details

Official title: Combination Versus Monotherapy With Alpha Blocker and Anticholinergics to Relieve Urinary Stent Symptoms

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Ureteral stent symptom questionnaire score

Ureteral stent symptom questionnaire score

Ureteral stent symptom questionnaire score

Ureteral stent symptom questionnaire score

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Vista Medical Center East, Waukegan, Illinois 60085, United States

Winnipeg Health Sciences Center, Winnipeg, Manitoba, Canada

Meriter Health Services, Madison, Wisconsin 53715, United States

University of Wisconsin, Madison, Wisconsin 53792, United States

Additional Information

Starting date: November 2012
Last updated: August 26, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017