Daily Versus Twice Per Day Tamsulosin for Ureteral Stent Symptoms

Status:Enrolling by invitation
Age Range:18 - 70
Start Date:February 18, 2019
End Date:December 2021

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The Effect of Daily Versus Twice Per Day Tamsulosin on Ureteral Stent Symptoms Following Ureteroscopy for Nephrolithiasis

A single-center prospective, randomized study to assess two different dosing regimens (0.4 mg
QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort will be completed.

Ureteral stents are commonly used to maintain patency of the ureter and are placed for
several common reasons including ureteral obstruction due to nephrolithiasis, cancer, or
fibrosis as well as after surgical interventions involving ureteroscopy, ureteral anastomoses
or prophylactically prior to extracorporeal shock wave lithotripsy. Ureteral stents have been
associated with significant discomfort and dissatisfaction among patients.5 Bosio and
colleagues noted that among patients with indwelling stents, 59.1% reported daily urinary
frequency ≥ 1 per hour, 90.1% reported ≥ 1 nocturnal micturition episodes, 86.6% reported
urinary urgency, and 82.3% reported dysuria. Further, 83.2% complained of pain, mostly in the
kidney (67.9%) or in the bladder area (31.3%), particularly during physical activity. Over
90% of patients reported that this pain interfered with their everyday life.

The Ureteric Stent Symptom Questionnaire (USSQ) was developed in 2003 by Joshi and colleagues
to quantify patients' discomfort relating specifically to ureteral stents. The USSQ measures
several domains relating to stent pain including general health, urinary issues, pain, work
performance, sexual matters, and quality of life with stent in situ. The USSQ has been
validated and translated and is currently a widely used measure.

While commonly used for treatment of benign prostatic hyperplasia, several studies have
evaluated the efficacy of α-blockers for stent pain and have demonstrated a significant
improvement in USSQ scores using α-blockers (mean reduction of 8.4 in urinary symptom scores
and 7.2 in body pain scores). To date, randomized controlled trials have used one of two
types of α-blockers: tamsulosin (0.4mg) vs. alfuzosin (10 mg). In treating benign prostatic
hyperplasia, a total maximum dose of 0.8mg tamsulosin is used (either 0.4mg BID or 0.8mg
daily), which has shown increased efficacy compared to the 0.4mg QD dose without an increase
in adverse effects. Currently, tamsulosin 0.4mg daily is the off-label dosage indicated for
lower urinary tract symptoms for patients with an indwelling stent. No study to date,
however, has evaluated the clinical impact of a higher daily dose of tamsulosin (0.8mg) on
stent-related symptoms. The objective of this study is to assess two different dosing
regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort.

Inclusion Criteria:

- Patients between the ages of 18 and 70 years old.

- Planning to undergo ureteroscopy with ureteral stent placement at our site.

- Able to read and understand an English language survey (USSQ).

Exclusion Criteria:

1. Patients who are unable to provide informed consent.

2. Patients who are already taking an alpha-blocker.

3. Patients with hypersensitivity or known adverse side effects of tamsulosin or its
ingredients and those who are not candidates for tamsulosin per attending Urologist

4. Patients with a preexisting bladder condition including UTI within 30 days of the

5. Patients with hepatitis C on boceprevir.

6. Patients who have medical conditions known to be associated with chronic pain, those
taking medications for chronic pain such as gabapentin or a chronic opioid per the
judgement of the PI, or those with a pain contract on file.

7. Women who are pregnant or planning to become pregnant.
We found this trial at
1900 South Avenue
La Crosse, Wisconsin 54601
La Crosse, WI
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