Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation



Status:Recruiting
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:11/29/2018
Start Date:November 12, 2018
End Date:November 2022
Contact:Alexandra Dahlgren
Email:adahlgren@kumc.edu
Phone:913-574-0847

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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.

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.

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
We found this trial at
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Kansas City, Kansas 66160
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