Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT01741454
• Collaborator: (none)
• Enrollment: 181
• Location: 1
• Arms: 4
• Duration (Months): 64.9
• Patients Per Site Per Month: 2.8

Study Details

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.

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

Study Design

• Study Type: Interventional
• 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: Nov 1, 2012
• Actual Primary Completion Date: Mar 30, 2018
• Actual Study Completion Date: Mar 30, 2018

Arms and Interventions

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 Names: 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 Names: Flomax (TM) ; Drug: Tolterodine ER; 4 mg by mouth once a day.; Other Names: 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 Names: 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 Names: Flomax (TM) ; Drug: Tolterodine ER; 4 mg by mouth once a day.; Other Names: Detrol (TM)

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

4. Prior hypersensitivity or allergy to tolterodine

5. Patients with severe hepatic impairment (Child-Pugh Class C)

6. Patients with uncontrolled close (narrow) angle glaucoma

7. Patients with urinary retention

8. Current anticholinergic use

9. Chronic pelvic pain syndromes (e.g. acute/chronic prostatitis, interstitial cystitis)

10. Women who are pregnant or nursing

11. Under 18 years of age

12. Prior hypersensitivity or allergy to tolterodine

13. Patients with severe hepatic impairment (Child-Pugh Class C)

14. Patients with uncontrolled close (narrow) angle glaucoma

15. Patients with urinary retention

16. Unable to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• University of Wisconsin, Madison

Investigators

• Principal Investigator: Stephen Nakada, MD, Univeristy of Wisconsin

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 17, 2017

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT01741454
• Other Study ID Numbers: 2017-0755; 2012-0279
• First Posted: Dec 5, 2012
• Last Update Posted: Jul 10, 2019
• Last Verified: Jun 1, 2019

• 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: Ureteral Obstruction; Tamsulosin; Tolterodine Tartrate

Study Results

Participant Flow

Pre-assignment Detail	The enrollment is slow, drop out rate is high, thus, we decide to stop enrolling.

Arm/Group Title	Tamsulosin Plus Placebo 7 Day	Tamsulosin Plus Tolterodine ER 7 Day	Tamsulosin Plus Placebo 21 Day	Tamsulosin Plus Tolterodine ER 21 Day
Arm/Group 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: 0.4 mg by mouth once per day for 7 days	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 for 7 days Tolterodine ER: 4 mg by mouth once a day for 7 days	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 for 21 days	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 for 21 days Tolterodine ER: 4 mg by mouth once a day for 21 days
Period Title: Overall Study
STARTED	49	50	39	43
COMPLETED	36	44	22	21
NOT COMPLETED	13	6	17	22

Baseline Characteristics

Arm/Group Title	Tamsulosin Plus Placebo 7 Day Treatment	Tamsulosin Plus Tolterodine ER 7 Day Treatment	Tamsulosin Plus Placebo 21 Day Treatment	Tamsulosin Plus Tolterodine ER 21 Day Treatment	Total
Arm/Group 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: 0.4 mg by mouth once per day.	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.	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.	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.	Total of all reporting groups
Overall Participants	36	44	22	21	123
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.8 (18)	51.5 (12.7)	57.3 (10.3)	56.9 (16.2)	53.4 (14.8)
Sex: Female, Male (Count of Participants)
Female	15 41.7%	25 56.8%	10 45.5%	11 52.4%	61 49.6%
Male	21 58.3%	19 43.2%	12 54.5%	10 47.6%	62 50.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	36 100%	44 100%	22 100%	21 100%	123 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

For all sub-scales, we reported the average score, the higher values suggest worse outcomes.

Arm/Group Title	Tamsulosin Plus Placebo 7-day Treatment	Tamsulosin Plus Tolterodine ER 7-day Treatment	Tamsulosin Plus Placebo 21-day Treatment	Tamsulosin Plus Tolterodine ER 21-day Treatment
Arm/Group 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: 0.4 mg by mouth once per day for 7 dyas	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 for 7 days Tolterodine ER: 4 mg by mouth once a day for 7 days	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 for 21 dyas	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 for 21days Tolterodine ER: 4 mg by mouth once a day for 21 days
Measure Participants	36	44	22	21
Urinary index	1.76 (0.46)	1.84 (0.39)	2.02 (0.27)	1.93 (0.48)
Pain score	1.95 (0.74)	2.13 (0.94)	2.49 (0.7)	1.88 (0.7)
General health score	1.87 (0.55)	2.04 (0.83)	2.15 (0.6)	2.07 (0.6)
Work	1.65 (0.83)	1.76 (0.91)	2.05 (0.96)	1.18 (0.4)
Sexual matters	1.60 (0.6)	1.41 (0.41)	1.77 (0.73)	1.57 (0.63)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Same

Arm/Group Title	Tamsulosin Plus Placebo 7-day Treatment	Tamsulosin Plus Tolterodine ER 7-day Treatment	Tamsulosin Plus Placebo 21-day Treatment	Tamsulosin Plus Tolterodine ER 21-day Treatment
Arm/Group 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: 0.4 mg by mouth once per day.	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.	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.	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.
Measure Participants	36	44	22	21
Urinary index	2.95 (0.45)	2.91 (0.55)	2.98 (0.64)	2.83 (0.63)
Pain score	2.66 (0.79)	2.89 (0.98)	2.9 (0.95)	2.71 (0.76)
General health score	2.35 (0.74)	2.69 (0.85)	2.64 (0.85)	2.78 (0.95)
Work	2.04 (0.97)	2.92 (1.29)	2.1 (1.05)	1.79 (1.21)
Sexual matters	2.07 (1.01)	2 (0.91)	1.83 (0.76)	1.75 (1.06)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

same

Arm/Group Title	Tamsulosin Plus Placebo 7-day Treatment	Tamsulosin Plus Tolterodine ER 7-day Treatment	Tamsulosin Plus Placebo 21-day Treatment	Tamsulosin Plus Tolterodine ER 21-day Treatment
Arm/Group 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: 0.4 mg by mouth once per day.	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.	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.	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.
Measure Participants	36	44	22	21
Urinary index	2.46 (0.58)	2.55 (0.63)	2.49 (0.48)	2.46 (0.66)
Pain score	2.39 (0.94)	2.49 (0.97)	2.58 (0.83)	2.4 (0.86)
General health score	2.34 (0.92)	2.33 (0.8)	2.52 (0.83)	2.28 (0.75)
Work	2.81 (0.88)	2.61 (1.19)	1.94 (1.05)	1.47 (0.67)
Sexual matters	1.5 (0.4)	1.59 (0.76)	1.75 (0.69)	2.9 (1.19)

4. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

same

Arm/Group Title	Tamsulosin Plus Placebo 7-day Treatment	Tamsulosin Plus Tolterodine ER 7-day Treatment	Tamsulosin Plus Placebo 21-day Treatment	Tamsulosin Plus Tolterodine ER 21-day Treatment
Arm/Group 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: 0.4 mg by mouth once per day.	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.	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.	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.
Measure Participants	36	44	22	21
Urinary index	1.72 (0.45)	1.91 (0.53)	1.85 (0.46)	2.14 (0.61)
Pain score	1.66 (0.91)	1.66 (0.79)	1.97 (1.01)	2.08 (0.47)
General health score	1.73 (0.71)	1.67 (0.62)	1.84 (1.02)	1.99 (0.75)
Work	1.57 (0.95)	1.41 (0.57)	2.13 (1.36)	1.56 (0.91)
Sexual matters	1.42 (0.4)	1.3 (0.35)	1.58 (0.58)	2.42 (1.5)

Adverse Events

Time Frame	from the first week of enrollment to 6 months.
Adverse Event Reporting Description	The study drugs being used are Tamsulosin and Tolterodine ER. Both drugs are FDA-approved for treating specific conditions and are routinely used in urology for other conditions as well. Previous studies showed that most of side effects are bothersome at worst to the patient.
Arm/Group Title	Tamsulosin Plus Placebo 7 Day Treatment		Tamsulosin Plus Tolterodine ER 7 Day Treatment		Tamsulosin Plus Placebo 21 Day Treatment		Tamsulosin Plus Tolterodine ER 21 Day Treatment
Arm/Group 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: 0.4 mg by mouth once per day.		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.		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.		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.
All Cause Mortality
	Tamsulosin Plus Placebo 7 Day Treatment		Tamsulosin Plus Tolterodine ER 7 Day Treatment		Tamsulosin Plus Placebo 21 Day Treatment		Tamsulosin Plus Tolterodine ER 21 Day Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/50 (0%)		0/39 (0%)		0/43 (0%)
Serious Adverse Events
	Tamsulosin Plus Placebo 7 Day Treatment		Tamsulosin Plus Tolterodine ER 7 Day Treatment		Tamsulosin Plus Placebo 21 Day Treatment		Tamsulosin Plus Tolterodine ER 21 Day Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/50 (0%)		0/39 (0%)		0/43 (0%)
Other (Not Including Serious) Adverse Events
	Tamsulosin Plus Placebo 7 Day Treatment		Tamsulosin Plus Tolterodine ER 7 Day Treatment		Tamsulosin Plus Placebo 21 Day Treatment		Tamsulosin Plus Tolterodine ER 21 Day Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/50 (0%)		0/39 (0%)		0/43 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.