Clinical trial NCT01741454: Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction
Official title: Combination Versus Monotherapy With Alpha Blocker and Anticholinergics to Relieve Urinary Stent Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ureteral Obstruction
Keywords: Tolterodine
Tamsulosin
Ureteral Obstruction
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility 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. Women who are pregnant or nursing
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

Primary outcomes:
measure: Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion
timeFrame: Up to 24 hours prior to stent insertion
measure: Ureteral Stent Symptom Questionnaire Score
timeFrame: 42-48 hours post-stent insertion
measure: Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion
timeFrame: 5-7 days post-stent insertion
measure: Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal
timeFrame: Up to 24 hours after stent removal. Removal will occur 5 to 7 days after insertion.
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Univeristy of Wisconsin
name: Stephen Nakada, MD
role: PRINCIPAL_INVESTIGATOR
References: