Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation (HyTa Stent)

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.

Study Overview

• Status: Terminated
• Conditions: Lower Urinary Tract Symptoms
• Intervention / Treatment: Drug: Hyoscyamine; Drug: Tamsulosin

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hyoscyamine; Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort	Drug: Hyoscyamine; Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent
Active Comparator: Tamsulosin; 0.4 mg tab orally daily	Drug: Tamsulosin; Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ureteral Stent Symptom Questionnaire Score	To evaluate the efficacy of hyoscyamine compared to tamsulosin in improving the lower urinary tract symptoms of patients with indwelling double-J ureteral stents as assessed by the validated Ureteral Stent Symptom Questionnaire (USSQ).	Three Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional Medication Needed	To determine if there is a difference between the amount of additional medications needed to treat stent related discomfort between patients receiving hyoscyamine versus those that receive tamsulosin	Three Years
Factors That Determine if Additional Medication Needed	To determine factors contributing to patients needing additional medication for treatment of stent-related discomfort	Three Years

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Anti-Arrhythmia Agents; Adjuvants, Anesthesia; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Urological Agents; Adrenergic Antagonists; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Parasympatholytics; Mydriatics; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin; Hyoscyamine
• Other Study ID Numbers: HSC 142994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No