Ureteral Obstruction Clinical Trial
Official title:
Combination Versus Monotherapy With Alpha Blocker and Anticholinergics to Relieve Urinary Stent Symptoms
Verified date | June 2019 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 181 |
Est. completion date | March 30, 2018 |
Est. primary completion date | March 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Up to 24 hours prior to stent insertion | |
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. | 42-48 hours post-stent insertion | |
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. | 5-7 days post-stent insertion | |
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. | Up to 24 hours after stent removal. Removal will occur 5 to 7 days after insertion. |
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