Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation

Lower Urinary Tract Symptoms Clinical Trial

— HyTa Stent  

Official title:

Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03750656
• Other study ID #: HSC 142994
• Status: Terminated
• Phase: Phase 4
• Start date: November 12, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Intervention

Drug:
• Hyoscyamine
Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent
• Tamsulosin
Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent

Locations

Country	Name	City	State
United States	University of Kansas Health System	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Factors that Determine if Additional Medication Needed	To determine factors contributing to patients needing additional medication for treatment of stent-related discomfort	Three Years