HyTa Stent: Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT03750656

Collaborator

(none)

Enrollment

Location

Arms

21.6

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized open-blind clinical trialRandomized 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 :

Nov 12, 2018

Actual Primary Completion Date :

Aug 31, 2020

Actual Study Completion Date :

Aug 31, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Health System	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Duchene, MD, Associate Professor, University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT03750656

Other Study ID Numbers:

HSC 142994

First Posted:

Nov 23, 2018

Last Update Posted:

Sep 7, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Lower Urinary Tract Symptoms

Hyoscyamine

Tamsulosin

Study Results

No Results Posted as of Sep 7, 2020