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

Primary Purpose

Lower Urinary Tract Symptoms

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hyoscyamine
Tamsulosin
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hyoscyamine

Tamsulosin

Arm Description

Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort

0.4 mg tab orally daily

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
Factors that Determine if Additional Medication Needed
To determine factors contributing to patients needing additional medication for treatment of stent-related discomfort

Full Information

First Posted
November 16, 2018
Last Updated
September 3, 2020
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03750656
Brief Title
Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation
Acronym
HyTa Stent
Official Title
Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Not accruing patients quickly enough
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized open-blind clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyoscyamine
Arm Type
Active Comparator
Arm Description
Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort
Arm Title
Tamsulosin
Arm Type
Active Comparator
Arm Description
0.4 mg tab orally daily
Intervention Type
Drug
Intervention Name(s)
Hyoscyamine
Intervention Description
Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Description
Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent
Primary Outcome Measure Information:
Title
Ureteral Stent Symptom Questionnaire Score
Description
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).
Time Frame
Three Years
Secondary Outcome Measure Information:
Title
Additional Medication Needed
Description
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
Time Frame
Three Years
Title
Factors that Determine if Additional Medication Needed
Description
To determine factors contributing to patients needing additional medication for treatment of stent-related discomfort
Time Frame
Three Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Kansas Health System
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation

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