Daily Versus Twice Per Day Tamsulosin for Ureteral Stent Symptoms

February 22, 2019 updated by: Kara Kallies, Gundersen Lutheran Medical Foundation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: tamsulosin QD + Placebo
0.4 mg tamsulosin QD + Placebo QD
Other: Placebo
Placebo
Drug: Tamsulosin BID
comparison of once daily versus twice daily tamsulosin
Experimental: tamsulosin BID
0.4 mg tamsulosin BID
Drug: Tamsulosin BID
comparison of once daily versus twice daily tamsulosin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week post-stent placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gundersen Lutheran Medical Foundation

Investigators

  • Principal Investigator: Matthew Ferroni, MD, Gundersen Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2019

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 4, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 10, 2019

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 22, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-18-11-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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