Ureteral Diseases Clinical Trial
Official title:
The Effect of Daily Versus Twice Per Day Tamsulosin on Ureteral Stent Symptoms Following Ureteroscopy for Nephrolithiasis
Verified date | February 2019 |
Source | Gundersen Lutheran Medical Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A single-center prospective, randomized study to assess two different dosing regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort will be completed.
Status | Enrolling by invitation |
Enrollment | 80 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients between the ages of 18 and 70 years old. - Planning to undergo ureteroscopy with ureteral stent placement at our site. - Able to read and understand an English language survey (USSQ). Exclusion Criteria: 1. Patients who are unable to provide informed consent. 2. Patients who are already taking an alpha-blocker. 3. Patients with hypersensitivity or known adverse side effects of tamsulosin or its ingredients and those who are not candidates for tamsulosin per attending Urologist discretion. 4. Patients with a preexisting bladder condition including UTI within 30 days of the procedure. 5. Patients with hepatitis C on boceprevir. 6. Patients who have medical conditions known to be associated with chronic pain, those taking medications for chronic pain such as gabapentin or a chronic opioid per the judgement of the PI, or those with a pain contract on file. 7. Women who are pregnant or planning to become pregnant. |
Country | Name | City | State |
---|---|---|---|
United States | Gundersen Health System | La Crosse | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Gundersen Lutheran Medical Foundation |
United States,
Bosio A, Alessandria E, Dalmasso E, Peretti D, Agosti S, Bisconti A, Destefanis P, Passera R, Gontero P. How bothersome double-J ureteral stents are after semirigid and flexible ureteroscopy: a prospective single-institution observational study. World J Urol. 2019 Jan;37(1):201-207. doi: 10.1007/s00345-018-2376-6. Epub 2018 Jun 19. — View Citation
Dellis AE, Papatsoris AG, Keeley FX Jr, Bamias A, Deliveliotis C, Skolarikos AA. Tamsulosin, Solifenacin, and Their Combination for the Treatment of Stent-Related Symptoms: A Randomized Controlled Study. J Endourol. 2017 Jan;31(1):100-109. doi: 10.1089/end.2016.0663. Epub 2016 Nov 29. — View Citation
Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. — View Citation
Koprowski C, Kim C, Modi PK, Elsamra SE. Ureteral Stent-Associated Pain: A Review. J Endourol. 2016 Jul;30(7):744-53. doi: 10.1089/end.2016.0129. Epub 2016 May 23. Review. — View Citation
Lamb AD, Vowler SL, Johnston R, Dunn N, Wiseman OJ. Meta-analysis showing the beneficial effect of a-blockers on ureteric stent discomfort. BJU Int. 2011 Dec;108(11):1894-902. doi: 10.1111/j.1464-410X.2011.10170.x. Epub 2011 Mar 31. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ureteric Stent Symptoms Questionnaire | Scales for each question are 1 to 5, with 5 indicated more severe symptoms. Subscale scores are the sum of all questions included in the subscale. | 1 week post-stent placement |
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