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Daily Versus Twice Per Day Tamsulosin for Ureteral Stent Symptoms

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ClinicalTrials.gov Identifier: NCT03799120
Recruitment Status : Unknown
Verified February 2019 by Kara Kallies, Gundersen Lutheran Medical Foundation.
Recruitment status was:  Enrolling by invitation
First Posted : January 10, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Kara Kallies, Gundersen Lutheran Medical Foundation

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ureteral Diseases Drug: Tamsulosin BID Other: Placebo Phase 4

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Daily Versus Twice Per Day Tamsulosin on Ureteral Stent Symptoms Following Ureteroscopy for Nephrolithiasis
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: tamsulosin QD + Placebo
0.4 mg tamsulosin QD + Placebo QD
 Drug: Tamsulosin BID
comparison of once daily versus twice daily tamsulosin

Other: Placebo
Placebo
Experimental: tamsulosin BID
0.4 mg tamsulosin BID
 Drug: Tamsulosin BID
comparison of once daily versus twice daily tamsulosin


Outcome Measures
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Primary Outcome Measures :
  1. Ureteric Stent Symptoms Questionnaire [ Time Frame: 1 week post-stent placement ]
    Scales for each question are 1 to 5, with 5 indicated more severe symptoms. Subscale scores are the sum of all questions included in the subscale.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 discretion.
  4. Patients with a preexisting bladder condition including UTI within 30 days of the procedure.
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799120


Locations
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United States, Wisconsin
Gundersen Health System
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Gundersen Lutheran Medical Foundation
Investigators
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Principal Investigator: Matthew Ferroni, MD Gundersen Health System
More Information
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Publications:

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Responsible Party: Kara Kallies, Academic Researcher / study coordinator, Gundersen Lutheran Medical Foundation
ClinicalTrials.gov Identifier: NCT03799120    
Other Study ID Numbers: 2-18-11-001
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Ureteral Diseases
Urologic Diseases
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents