Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation

Phase 4

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Hyoscyamine	Hyoscyamine	Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort
Tamsulosin	Tamsulosin	0.4 mg tab orally daily

Primary Outcome Measures

Name	Time	Method
Ureteral Stent Symptom Questionnaire Score	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

Name	Time	Method
Additional Medication Needed	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
Factors That Determine if Additional Medication Needed	Three Years	To determine factors contributing to patients needing additional medication for treatment of stent-related discomfort