Ureteral Obstruction
Conditions
Keywords
Tolterodine, Tamsulosin, Ureteral Obstruction
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
Interventions
DRUGTamsulosin
0.4 mg by mouth once per day.
DRUGTolterodine ER
4 mg by mouth once a day.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | 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 | 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. |
| Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
The enrollment is slow, drop out rate is high, thus, we decide to stop enrolling.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Tamsulosin: 0.4 mg by mouth once per day. | 36 |
| 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.
Tamsulosin: 0.4 mg by mouth once per day.
Tolterodine ER: 4 mg by mouth once a day. | 44 |
| Tamsulosin Plus Placebo 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.
Tamsulosin: 0.4 mg by mouth once per day. | 22 |
| 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.
Tamsulosin: 0.4 mg by mouth once per day.
Tolterodine ER: 4 mg by mouth once a day. | 21 |
| Total | 123 |
Baseline characteristics
| Characteristic | Tamsulosin Plus Tolterodine ER 7 Day Treatment | Tamsulosin Plus Placebo 21 Day Treatment | Tamsulosin Plus Tolterodine ER 21 Day Treatment | Total | Tamsulosin Plus Placebo 7 Day Treatment |
|---|---|---|---|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 12.7 | 57.3 years STANDARD_DEVIATION 10.3 | 56.9 years STANDARD_DEVIATION 16.2 | 53.4 years STANDARD_DEVIATION 14.8 | 48.8 years STANDARD_DEVIATION 18 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment United States | 44 Participants | 22 Participants | 21 Participants | 123 Participants | 36 Participants |
| Sex: Female, Male Female | 25 Participants | 10 Participants | 11 Participants | 61 Participants | 15 Participants |
| Sex: Female, Male Male | 19 Participants | 12 Participants | 10 Participants | 62 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 50 | 0 / 39 | 0 / 43 |
| other Total, other adverse events | 0 / 49 | 0 / 50 | 0 / 39 | 0 / 43 |
| serious Total, serious adverse events | 0 / 49 | 0 / 50 | 0 / 39 | 0 / 43 |
Outcome results
Primary
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
Population: Same
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score | Work | 2.04 score on a scale | Standard Deviation 0.97 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score | Pain score | 2.66 score on a scale | Standard Deviation 0.79 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score | Sexual matters | 2.07 score on a scale | Standard Deviation 1.01 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score | General health score | 2.35 score on a scale | Standard Deviation 0.74 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score | Urinary index | 2.95 score on a scale | Standard Deviation 0.45 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score | General health score | 2.69 score on a scale | Standard Deviation 0.85 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score | Work | 2.92 score on a scale | Standard Deviation 1.29 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score | Sexual matters | 2 score on a scale | Standard Deviation 0.91 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score | Pain score | 2.89 score on a scale | Standard Deviation 0.98 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score | Urinary index | 2.91 score on a scale | Standard Deviation 0.55 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score | General health score | 2.64 score on a scale | Standard Deviation 0.85 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score | Urinary index | 2.98 score on a scale | Standard Deviation 0.64 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score | Pain score | 2.9 score on a scale | Standard Deviation 0.95 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score | Work | 2.1 score on a scale | Standard Deviation 1.05 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score | Sexual matters | 1.83 score on a scale | Standard Deviation 0.76 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score | Work | 1.79 score on a scale | Standard Deviation 1.21 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score | Pain score | 2.71 score on a scale | Standard Deviation 0.76 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score | Urinary index | 2.83 score on a scale | Standard Deviation 0.63 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score | General health score | 2.78 score on a scale | Standard Deviation 0.95 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score | Sexual matters | 1.75 score on a scale | Standard Deviation 1.06 |
Primary
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
Population: same
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Urinary index | 2.46 score on a scale | Standard Deviation 0.58 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Work | 2.81 score on a scale | Standard Deviation 0.88 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Sexual matters | 1.5 score on a scale | Standard Deviation 0.4 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | General health score | 2.34 score on a scale | Standard Deviation 0.92 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Pain score | 2.39 score on a scale | Standard Deviation 0.94 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | General health score | 2.33 score on a scale | Standard Deviation 0.8 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Work | 2.61 score on a scale | Standard Deviation 1.19 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Sexual matters | 1.59 score on a scale | Standard Deviation 0.76 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Pain score | 2.49 score on a scale | Standard Deviation 0.97 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Urinary index | 2.55 score on a scale | Standard Deviation 0.63 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | General health score | 2.52 score on a scale | Standard Deviation 0.83 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Urinary index | 2.49 score on a scale | Standard Deviation 0.48 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Pain score | 2.58 score on a scale | Standard Deviation 0.83 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Work | 1.94 score on a scale | Standard Deviation 1.05 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Sexual matters | 1.75 score on a scale | Standard Deviation 0.69 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Work | 1.47 score on a scale | Standard Deviation 0.67 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Pain score | 2.4 score on a scale | Standard Deviation 0.86 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Urinary index | 2.46 score on a scale | Standard Deviation 0.66 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | General health score | 2.28 score on a scale | Standard Deviation 0.75 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion | Sexual matters | 2.9 score on a scale | Standard Deviation 1.19 |
Primary
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.
Population: same
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Work | 1.57 score on a scale | Standard Deviation 0.95 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Pain score | 1.66 score on a scale | Standard Deviation 0.91 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Sexual matters | 1.42 score on a scale | Standard Deviation 0.4 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | General health score | 1.73 score on a scale | Standard Deviation 0.71 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Urinary index | 1.72 score on a scale | Standard Deviation 0.45 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | General health score | 1.67 score on a scale | Standard Deviation 0.62 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Work | 1.41 score on a scale | Standard Deviation 0.57 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Sexual matters | 1.3 score on a scale | Standard Deviation 0.35 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Pain score | 1.66 score on a scale | Standard Deviation 0.79 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Urinary index | 1.91 score on a scale | Standard Deviation 0.53 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | General health score | 1.84 score on a scale | Standard Deviation 1.02 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Urinary index | 1.85 score on a scale | Standard Deviation 0.46 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Pain score | 1.97 score on a scale | Standard Deviation 1.01 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Work | 2.13 score on a scale | Standard Deviation 1.36 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Sexual matters | 1.58 score on a scale | Standard Deviation 0.58 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Work | 1.56 score on a scale | Standard Deviation 0.91 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Pain score | 2.08 score on a scale | Standard Deviation 0.47 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Urinary index | 2.14 score on a scale | Standard Deviation 0.61 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | General health score | 1.99 score on a scale | Standard Deviation 0.75 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal | Sexual matters | 2.42 score on a scale | Standard Deviation 1.5 |
Primary
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
Population: For all sub-scales, we reported the average score, the higher values suggest worse outcomes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Pain score | 1.95 score on a scale | Standard Deviation 0.74 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Urinary index | 1.76 score on a scale | Standard Deviation 0.46 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | General health score | 1.87 score on a scale | Standard Deviation 0.55 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Sexual matters | 1.60 score on a scale | Standard Deviation 0.6 |
| Tamsulosin Plus Placebo 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Work | 1.65 score on a scale | Standard Deviation 0.83 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Sexual matters | 1.41 score on a scale | Standard Deviation 0.41 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Urinary index | 1.84 score on a scale | Standard Deviation 0.39 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Pain score | 2.13 score on a scale | Standard Deviation 0.94 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | General health score | 2.04 score on a scale | Standard Deviation 0.83 |
| Tamsulosin Plus Tolterodine ER 7-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Work | 1.76 score on a scale | Standard Deviation 0.91 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Sexual matters | 1.77 score on a scale | Standard Deviation 0.73 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Work | 2.05 score on a scale | Standard Deviation 0.96 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Urinary index | 2.02 score on a scale | Standard Deviation 0.27 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Pain score | 2.49 score on a scale | Standard Deviation 0.7 |
| Tamsulosin Plus Placebo 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | General health score | 2.15 score on a scale | Standard Deviation 0.6 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Pain score | 1.88 score on a scale | Standard Deviation 0.7 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | General health score | 2.07 score on a scale | Standard Deviation 0.6 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Urinary index | 1.93 score on a scale | Standard Deviation 0.48 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Work | 1.18 score on a scale | Standard Deviation 0.4 |
| Tamsulosin Plus Tolterodine ER 21-day Treatment | Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion | Sexual matters | 1.57 score on a scale | Standard Deviation 0.63 |