NCT03750656

Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DRUG	Hyoscyamine	Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent
DRUG	Tamsulosin	Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent

Timeline

• Start date: 2018-11-12
• Primary completion: 2020-08-31
• Completion: 2020-08-31
• First posted: 2018-11-23
• Last updated: 2024-12-03
• Results posted: 2024-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study