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Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation

NCT ID: NCT03750656

Last Updated: 2024-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-12

Study Completion Date

2020-08-31

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.

Conditions

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Lower Urinary Tract Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized open-blind clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyoscyamine

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

Group Type ACTIVE_COMPARATOR

Hyoscyamine

Intervention Type DRUG

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

Tamsulosin

0.4 mg tab orally daily

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

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

Interventions

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Hyoscyamine

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

Intervention Type DRUG

Tamsulosin

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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David Duchene, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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HSC 142994

Identifier Type: -

Identifier Source: org_study_id