Overview

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