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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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Gundersen Health System
La Crosse, Wisconsin, United States
Start Date
February 18, 2019
Primary Completion Date
December 1, 2021
Completion Date
December 1, 2021
Last Updated
February 25, 2019
80
ESTIMATED participants
Tamsulosin BID
DRUG
Placebo
OTHER
Lead Sponsor
Gundersen Lutheran Medical Foundation
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