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Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction

This study is currently recruiting participants.
Verified December 2012 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01741454
First received: November 29, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Ureteral Obstruction
 Drug: Tamsulosin
Drug: Tolterodine ER
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination Versus Monotherapy With Alpha Blocker and Anticholinergics to Relieve Urinary Stent Symptoms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Ureteral stent symptom questionnaire score [ Time Frame: Up to 24 hours prior to stent insertion ] [ Designated as safety issue: No ]
    Ureteral stent symptom questionnaire score

  • Ureteral stent symptom questionnaire score [ Time Frame: 42-48 hours post-stent insertion ] [ Designated as safety issue: No ]
    Ureteral stent symptom questionnaire score

  • Ureteral stent symptom questionnaire score [ Time Frame: 5 days post-stent insertion ] [ Designated as safety issue: No ]
    Ureteral stent symptom questionnaire score

  • Ureteral stent symptom questionnaire score [ Time Frame: Up to 24 hours after stent removal. Removal will occur 5 to 7 days after insertion. ] [ Designated as safety issue: No ]
    Ureteral stent symptom questionnaire score


Estimated Enrollment: 106
Study Start Date: November 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tamsulosin plus placebo
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.
 Drug: Tamsulosin
0.4 mg by mouth once per day.
Other Name: Flomax (TM)
Experimental: Tamsulosin plus Tolterodine ER

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.

 Drug: Tamsulosin
0.4 mg by mouth once per day.
Other Name: Flomax (TM)
Drug: Tolterodine ER
4 mg by mouth once a day.
Other Name: Detrol (TM)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with unilateral ureteral stent placement for urolithiasis

Exclusion Criteria:

  1. Non-stone related stent insertion,
  2. Pre-existing lower urinary tract symptoms
  3. Active urinary tract infection

  4. 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
  5. Current alpha-blocker or anticholinergic use
  6. Chronic pelvic pain syndromes (e.g. acute/chronic prostatitis, interstitial cystitis)
  7. Pregnant females
  8. Under 18 years of age
  9. Prior hypersensitivity or allergy to tolterodine
  10. Patients with severe hepatic impairment (Child-Pugh Class C)
  11. Patients with uncontrolled close (narrow) angle glaucoma
  12. Patients with urinary retention
  13. Unable to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01741454

Contacts
Contact: Nicky Kurtzweil, JD (608) 262-9383 kurtzweil@surgery.wisc.edu
Contact: Lauren Howard, MPH (608) 265-6648 howard@surgery.wisc.edu

Locations
United States, Illinois
Vista Medical Center East Recruiting
Waukegan, Illinois, United States, 60085
Contact: Sutchin Patel, MD            
Principal Investigator: Sutchin Patel, MD            
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Nicky Kurtzweil, JD     608-262-9383     kurtzweil@surgery.wisc.edu    
Contact: Lauren Howard, MPH     608-265-6648     howard@surgery.wisc.edu    
Principal Investigator: Stephen Nakada, MD            
Meriter Health Services Recruiting
Madison, Wisconsin, United States, 53715
Contact: David Paolone, MD            
Principal Investigator: David Paolone, MD            
Canada, Manitoba
Winnipeg Health Sciences Center Recruiting
Winnipeg, Manitoba, Canada
Contact: Turki Al-Essawi, MD            
Principal Investigator: Turki Al-Essawi, MD            
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Stephen Nakada, MD Univeristy of Wisconsin
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01741454     History of Changes
Other Study ID Numbers: 2012-0279
Study First Received: November 29, 2012
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Tolterodine
Tamsulosin
Ureteral Obstruction

Additional relevant MeSH terms:
Ureteral Diseases
Ureteral Obstruction
Urologic Diseases
Cholinergic Antagonists
Tolterodine
Tamsulosin
Cholinergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Muscarinic Antagonists

ClinicalTrials.gov processed this record on May 23, 2013