Status:
TERMINATED
Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Lower Urinary Tract Symptoms
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this project is to compare the efficacy of hyoscyamine to tamsulosin monotherapy in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents.
Detailed Description
Ureteral stents are routinely used in a variety of urologic conditions. Unfortunately, indwelling ureteral stents commonly cause significant pain and discomfort due to irritation to the urinary system...
Eligibility Criteria
Inclusion
- Patients must be 18 years of age or older
- Patient must require placement of a ureteral stent(s), per standard of care, following routine urological procedures including, but not limited to, ureteroscopy, stone extraction, or management of upper tract transitional cell carcinoma
- Patient must agree to abstain from other clinical studies during the study period
Exclusion
- Patients younger than 18 years of age
- Patients with chronic or pre-existing indwelling stents
- Patients currently receiving anticholinergic or alpha blocker therapy
- Patients with chronic opioid or analgesic usage
- Patients with chronic pain syndrome or symptomatic benign prostatic hyperplasia
- Patients with an active untreated urinary tract infection
- Patients who are currently pregnant or nursing
- Patients with allergies or contraindication to either tamsulosin or hyoscyamine
- Patients on active chemotherapy
- Patients currently receiving other investigational therapy
- Patients who are unable to sign consent/answer questionnaire due to compromised mental capacity or language barrier (the questionnaire is not validated in other languages)
- Patients who have a stent placed emergently for an obstructing stone or septic stone without immediate stone removal,
- Any stents placed that will stay in for longer than 2 weeks
Key Trial Info
Start Date :
November 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03750656
Start Date
November 12 2018
End Date
August 31 2020
Last Update
December 3 2024
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160