Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation

Conditions
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Lower Urinary Tract Symptoms

Intervention / Treatment
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* Drug: Hyoscyamine
* Drug: Tamsulosin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized open-blind clinical trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |