NCT01741454

Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 participants 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 symptoms. The investigators suggest 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. Initially, a 7-day design (medical starts 7 days before stent insertion) was conducted to determine whether combination therapy with Tolterodine ER and Tamsulosin is more effective than monotherapy with tamsulosin alone in reducing stent symptoms. Previous studies showed that tolterodine ER therapy significantly reduces urinary symptoms by week 4 of medication therapy. Given the evidence that tolterodine ER requires a longer duration to have maximum benefit, in the second phase, investigators increased the duration of medication to start 2 weeks prior to surgery and continued for 7 days after surgery, for a total of 21 days of medication, to test whether combination therapy is more effective than monotherapy in reducing stent symptoms

Conditions

• Ureteral Obstruction

Interventions

Type	Name	Description
DRUG	Tamsulosin	0.4 mg by mouth once per day.
DRUG	Tolterodine ER	4 mg by mouth once a day.

Timeline

• Start date: 2012-11-01
• Primary completion: 2018-03-30
• Completion: 2018-03-30
• First posted: 2012-12-05
• Last updated: 2019-07-10
• Results posted: 2019-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study