Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-05 @ 2:47 AM
Study NCT ID:
NCT03750656
Status:
TERMINATED
Last Update Posted:
2024-12-03
First Post:
2018-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation
Sponsor:
University of Kansas Medical Center
Organization:
Study Overview
Official Title:
Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation
Status:
TERMINATED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not accruing patients quickly enough
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HyTa Stent
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. Many studies have looked at methods to reduce these uncomfortable symptoms ranging from altering stent designs to pharmacologic therapies attempting to alleviate stent-discomfort. However, stent-related discomfort continues to be an issue and is often the cause of their removal earlier than planned. While the efficacy of certain alpha blockers and anticholinergics in treating stent-related symptoms have been studied, the data for the use of hyoscyamine in this setting is lacking. A literature search yielded no studies evaluating the use of hyoscyamine in this setting to date. The investigators hypothesize that hyoscyamine (brand name Levsin) is equivalent to tamsulosin in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents due to its anticholinergic properties. Furthermore, the investigators hypothesize that patients in the hyoscyamine arm will not require additional pain medications (e.g. Pyridium, narcotics) to help control stent-related discomfort compared to the tamsulosin arm.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: