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Trial record 13 of 270 for:    Recruiting, Not yet recruiting, Available Studies | "Lower Urinary Tract Symptoms"

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

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ClinicalTrials.gov Identifier: NCT03750656
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
David Duchene, MD, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Lower Urinary Tract Symptoms Drug: Hyoscyamine Drug: Tamsulosin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized open-blind clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Ureteral Stent Symptom Questionnaire Score [ Time Frame: Three Years ]
    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 :
  1. Additional Medication Needed [ Time Frame: Three Years ]
    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

  2. Factors that Determine if Additional Medication Needed [ Time Frame: Three Years ]
    To determine factors contributing to patients needing additional medication for treatment of stent-related discomfort



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750656


Contacts
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Contact: Alexandra Dahlgren 913-574-0847 adahlgren@kumc.edu

Locations
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United States, Kansas
University of Kansas Health System Recruiting
Kansas City, Kansas, United States, 66160
Contact: Alexandra Dahlgren         
Sponsors and Collaborators
University of Kansas Medical Center

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Responsible Party: David Duchene, MD, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03750656     History of Changes
Other Study ID Numbers: HSC 142994
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tamsulosin
Hyoscyamine
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents