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Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741454
Recruitment Status : Completed
First Posted : December 5, 2012
Results First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.


Condition or disease Intervention/treatment Phase
Ureteral Obstruction Drug: Tamsulosin Drug: Tolterodine ER Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination Versus Monotherapy With Alpha Blocker and Anticholinergics to Relieve Urinary Stent Symptoms
Study Start Date : November 2012
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tamsulosin plus placebo 7-day treatment
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 7-day treatment

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)

Active Comparator: Tamsulosin plus placebo 21-day treamtnet
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 21-day treatment

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)




Primary Outcome Measures :
  1. Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion [ Time Frame: Up to 24 hours prior to stent insertion ]
    The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized.

  2. Ureteral Stent Symptom Questionnaire Score [ Time Frame: 42-48 hours post-stent insertion ]
    The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized.

  3. Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion [ Time Frame: 5-7 days post-stent insertion ]
    The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized.

  4. Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal [ Time Frame: Up to 24 hours after stent removal. Removal will occur 5 to 7 days after insertion. ]
    The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741454


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Stephen Nakada, MD Univeristy of Wisconsin
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01741454    
Other Study ID Numbers: 2017-0755
2012-0279 ( Other Identifier: HS IRB )
First Posted: December 5, 2012    Key Record Dates
Results First Posted: July 10, 2019
Last Update Posted: July 10, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Tolterodine
Tamsulosin
Ureteral Obstruction
Additional relevant MeSH terms:
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Ureteral Obstruction
Ureteral Diseases
Urologic Diseases
Tamsulosin
Tolterodine Tartrate
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents