Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation

• Status: Terminated
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas Medical Center
• Treatments: Hyoscyamine; Tamsulosin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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