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CompletedNCT01741454Updated Jul 10, 2019Results posted

Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction

A Phase 4 interventional study of Tamsulosin and Tolterodine ER in Ureteral Obstruction, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-10.

Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
181
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Ureteral Obstruction

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Keywords

  • Tolterodine
  • Tamsulosin
  • Ureteral Obstruction
03

In context

Ureteral Obstruction

45 studies on the registry are indexed under Ureteral Obstruction; 9 are open to participants now.

This study's enrollment of 181 is above the median of 53 across 31 interventional studies indexed under Ureteral Obstruction.

Browse Ureteral Obstruction studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,182 studies on the registry; 180 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 118 (76%) have results posted.

Browse University of Wisconsin, Madison studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with unilateral ureteral stent placement for urolithiasis

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
181 participants (actual)

Study arms

  • 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

  • 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 · Drug: Tolterodine ER

  • 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

  • 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 · Drug: Tolterodine ER

Interventions

  • DrugTamsulosin

    0.4 mg by mouth once per day.

    Also known as: Flomax (TM)

  • DrugTolterodine ER

    4 mg by mouth once a day.

    Also known as: Detrol (TM)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 24 hours prior to stent insertion

  2. 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.

    Time frame: 42-48 hours post-stent insertion

  3. 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.

    Time frame: 5-7 days post-stent insertion

  4. 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.

    Time frame: Up to 24 hours after stent removal. Removal will occur 5 to 7 days after insertion.

07

Results

Posted Jul 10, 2019

Participant flow

Participant flow — Overall Study
MilestoneTamsulosin Plus Placebo 7 DayTamsulosin Plus Tolterodine ER 7 DayTamsulosin Plus Placebo 21 DayTamsulosin Plus Tolterodine ER 21 Day
Started49503943
Completed36442221
Not completed1361722

Outcome measures

PrimaryUreteral 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.

Time frame:
Up to 24 hours prior to stent insertion
Reported as:
Mean · score on a scale
Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion
score on a scaleTamsulosin Plus Placebo 7-day TreatmentTamsulosin Plus Tolterodine ER 7-day TreatmentTamsulosin Plus Placebo 21-day TreatmentTamsulosin Plus Tolterodine ER 21-day Treatment
Urinary index1.76 ± 0.461.84 ± 0.392.02 ± 0.271.93 ± 0.48
Pain score1.95 ± 0.742.13 ± 0.942.49 ± 0.71.88 ± 0.7
General health score1.87 ± 0.552.04 ± 0.832.15 ± 0.62.07 ± 0.6
Work1.65 ± 0.831.76 ± 0.912.05 ± 0.961.18 ± 0.4
Sexual matters1.60 ± 0.61.41 ± 0.411.77 ± 0.731.57 ± 0.63
PrimaryUreteral 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.

Time frame:
42-48 hours post-stent insertion
Reported as:
Mean · score on a scale
Ureteral Stent Symptom Questionnaire Score
score on a scaleTamsulosin Plus Placebo 7-day TreatmentTamsulosin Plus Tolterodine ER 7-day TreatmentTamsulosin Plus Placebo 21-day TreatmentTamsulosin Plus Tolterodine ER 21-day Treatment
Urinary index2.95 ± 0.452.91 ± 0.552.98 ± 0.642.83 ± 0.63
Pain score2.66 ± 0.792.89 ± 0.982.9 ± 0.952.71 ± 0.76
General health score2.35 ± 0.742.69 ± 0.852.64 ± 0.852.78 ± 0.95
Work2.04 ± 0.972.92 ± 1.292.1 ± 1.051.79 ± 1.21
Sexual matters2.07 ± 1.012 ± 0.911.83 ± 0.761.75 ± 1.06
PrimaryUreteral 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.

Time frame:
5-7 days post-stent insertion
Reported as:
Mean · score on a scale
Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion
score on a scaleTamsulosin Plus Placebo 7-day TreatmentTamsulosin Plus Tolterodine ER 7-day TreatmentTamsulosin Plus Placebo 21-day TreatmentTamsulosin Plus Tolterodine ER 21-day Treatment
Urinary index2.46 ± 0.582.55 ± 0.632.49 ± 0.482.46 ± 0.66
Pain score2.39 ± 0.942.49 ± 0.972.58 ± 0.832.4 ± 0.86
General health score2.34 ± 0.922.33 ± 0.82.52 ± 0.832.28 ± 0.75
Work2.81 ± 0.882.61 ± 1.191.94 ± 1.051.47 ± 0.67
Sexual matters1.5 ± 0.41.59 ± 0.761.75 ± 0.692.9 ± 1.19
PrimaryUreteral 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.

Time frame:
Up to 24 hours after stent removal. Removal will occur 5 to 7 days after insertion.
Reported as:
Mean · score on a scale
Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal
score on a scaleTamsulosin Plus Placebo 7-day TreatmentTamsulosin Plus Tolterodine ER 7-day TreatmentTamsulosin Plus Placebo 21-day TreatmentTamsulosin Plus Tolterodine ER 21-day Treatment
Urinary index1.72 ± 0.451.91 ± 0.531.85 ± 0.462.14 ± 0.61
Pain score1.66 ± 0.911.66 ± 0.791.97 ± 1.012.08 ± 0.47
General health score1.73 ± 0.711.67 ± 0.621.84 ± 1.021.99 ± 0.75
Work1.57 ± 0.951.41 ± 0.572.13 ± 1.361.56 ± 0.91
Sexual matters1.42 ± 0.41.3 ± 0.351.58 ± 0.582.42 ± 1.5

Adverse events

Collected over from the first week of enrollment to 6 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tamsulosin Plus Placebo 7 Day Treatment0/49 (0%)0/49 (0%)0/49 (0%)
Tamsulosin Plus Tolterodine ER 7 Day Treatment0/50 (0%)0/50 (0%)0/50 (0%)
Tamsulosin Plus Placebo 21 Day Treatment0/39 (0%)0/39 (0%)0/39 (0%)
Tamsulosin Plus Tolterodine ER 21 Day Treatment0/43 (0%)0/43 (0%)0/43 (0%)

Baseline characteristics

Patients who dropped out were not analyzed

Age, Continuous
Age, Continuous(years)Tamsulosin Plus Placebo 7 Day TreatmentTamsulosin Plus Tolterodine ER 7 Day TreatmentTamsulosin Plus Placebo 21 Day TreatmentTamsulosin Plus Tolterodine ER 21 Day TreatmentTotal
Mean48.8 ± 1851.5 ± 12.757.3 ± 10.356.9 ± 16.253.4 ± 14.8
Sex: Female, Male
Sex: Female, Male(Participants)Tamsulosin Plus Placebo 7 Day TreatmentTamsulosin Plus Tolterodine ER 7 Day TreatmentTamsulosin Plus Placebo 21 Day TreatmentTamsulosin Plus Tolterodine ER 21 Day TreatmentTotal
Female1525101161
Male2119121062
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Tamsulosin Plus Placebo 7 Day TreatmentTamsulosin Plus Tolterodine ER 7 Day TreatmentTamsulosin Plus Placebo 21 Day TreatmentTamsulosin Plus Tolterodine ER 21 Day TreatmentTotal
Count of participants————0
Region of Enrollment
Region of Enrollment(Participants)Tamsulosin Plus Placebo 7 Day TreatmentTamsulosin Plus Tolterodine ER 7 Day TreatmentTamsulosin Plus Placebo 21 Day TreatmentTamsulosin Plus Tolterodine ER 21 Day TreatmentTotal
United States36442221123
08

Study locations

1 site
  • University of Wisconsin
    Madison, Wisconsin 53792, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 17, 2017

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of Mar 2018 and a completion of Mar 2018. It does not say whether these dates are actual or estimated.

Results were first posted in Jul 2019, 1 year 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2012
First posted
Dec 5, 2012
Start
Nov 2012
Primary completionActual
Mar 30, 2018
CompletionActual
Mar 30, 2018
Results first posted
Jul 10, 2019
Last update
Jul 10, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01741454
Lead sponsor
University of Wisconsin, Madison
Responsible party
Sponsor
First posted
Dec 5, 2012
Start date
Nov 2012
Primary completion
Mar 30, 2018
Completion
Mar 30, 2018
Results posted
Jul 10, 2019
Last update
Jul 10, 2019

Study contacts

Stephen Nakada, MD
principal investigator · Univeristy of Wisconsin

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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