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 scoreUreteral 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
|