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Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction

Primary Purpose

Ureteral Obstruction

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tamsulosin
Tolterodine ER
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteral Obstruction focused on measuring Tolterodine, Tamsulosin, Ureteral Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Tamsulosin plus placebo 7-day treatment

Tamsulosin plus Tolterodine ER 7-day treatment

Tamsulosin plus placebo 21-day treamtnet

Tamsulosin plus Tolterodine ER 21-day treatment

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Ureteral Stent Symptom Questionnaire Score 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.
Ureteral Stent Symptom Questionnaire Score
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.
Ureteral Stent Symptom Questionnaire Score 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.
Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal
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.

Secondary Outcome Measures

Full Information

First Posted
November 29, 2012
Last Updated
June 20, 2019
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01741454
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Obstruction
Keywords
Tolterodine, Tamsulosin, Ureteral Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamsulosin plus placebo 7-day treatment
Arm Type
Active Comparator
Arm 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.
Arm Title
Tamsulosin plus Tolterodine ER 7-day treatment
Arm Type
Experimental
Arm 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.
Arm Title
Tamsulosin plus placebo 21-day treamtnet
Arm Type
Active Comparator
Arm 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.
Arm Title
Tamsulosin plus Tolterodine ER 21-day treatment
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Flomax (TM)
Intervention Description
0.4 mg by mouth once per day.
Intervention Type
Drug
Intervention Name(s)
Tolterodine ER
Other Intervention Name(s)
Detrol (TM)
Intervention Description
4 mg by mouth once a day.
Primary Outcome Measure Information:
Title
Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion
Description
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.
Time Frame
Up to 24 hours prior to stent insertion
Title
Ureteral Stent Symptom Questionnaire Score
Description
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.
Time Frame
42-48 hours post-stent insertion
Title
Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion
Description
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.
Time Frame
5-7 days post-stent insertion
Title
Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal
Description
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.
Time Frame
Up to 24 hours after stent removal. Removal will occur 5 to 7 days after insertion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with unilateral ureteral stent placement for urolithiasis Exclusion Criteria: Pre-existing lower urinary tract symptoms Active urinary tract infection Contraindication to anticholinergic medication Prior hypersensitivity or allergy to tolterodine Patients with severe hepatic impairment (Child-Pugh Class C) Patients with uncontrolled close (narrow) angle glaucoma Patients with urinary retention Current anticholinergic use Chronic pelvic pain syndromes (e.g. acute/chronic prostatitis, interstitial cystitis) Women who are pregnant or nursing Under 18 years of age Prior hypersensitivity or allergy to tolterodine Patients with severe hepatic impairment (Child-Pugh Class C) Patients with uncontrolled close (narrow) angle glaucoma Patients with urinary retention Unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Nakada, MD
Organizational Affiliation
Univeristy of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction

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