Ureteral Obstruction Clinical Trial
Official title:
Combination Versus Monotherapy With Alpha Blocker and Anticholinergics to Relieve Urinary Stent Symptoms
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.
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
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