Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction

University of Wisconsin (UW)

Status and phase: Completed; Phase 4

Conditions: Ureteral Obstruction

Treatments: Drug: Tolterodine ER; Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT01741454

2017-0755

2012-0279 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 181 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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181 participants in 4 patient groups

Tamsulosin plus placebo 7-day treatment

Active Comparator group

Description:

Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.

Treatment:

Drug: Tamsulosin

Tamsulosin plus Tolterodine ER 7-day treatment

Experimental group

Description:

Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms. Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.

Treatment:

Drug: Tamsulosin

Drug: Tolterodine ER

Tamsulosin plus placebo 21-day treamtnet

Active Comparator group

Description:

Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms.

Treatment:

Drug: Tamsulosin

Tamsulosin plus Tolterodine ER 21-day treatment

Experimental group

Description:

Tamsulosin is a selective α1a-blocker (FlomaxTM), generic since 2009. It is an antagonist of α1-mediated contraction of prostate, bladder and proximal urethral smooth muscle, and as such, reduces urethral pressure and resistance, bladder outlet resistance, bladder hyperactivity, and consequently lower urinary tract symptoms. Tolterodine ER is an anticholinergic agent, which is used as one of the first line agents for detrusor overactivity.

Treatment:

Drug: Tamsulosin

Drug: Tolterodine ER