Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation

NCT03750656 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: HSC 142994
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Additional Medication Needed

  Three Years

• Factors That Determine if Additional Medication Needed

  Three Years

Study Arms (2)

Hyoscyamine

ACTIVE COMPARATOR

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

Drug: Hyoscyamine

Tamsulosin

ACTIVE COMPARATOR

0.4 mg tab orally daily

Drug: Tamsulosin

Interventions

Hyoscyamine DRUG

Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent

Hyoscyamine

Tamsulosin DRUG

Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent

Tamsulosin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Hyoscyamine; Tamsulosin

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Dr. David Duchene
• Organization: University of Kansas Medical Center

dduchene@kumc.edu

(913) 588-8721

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized open-blind clinical trial

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 23, 2018
• Study Start: November 12, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: December 3, 2024
• Results First Posted: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)