Silodosin Versus Tamsulosin for Treatment of Ureteral Stones

June 19, 2020 updated by: Albert Einstein Healthcare Network

Comparison of Silodosin vs. Tamsulosin on Spontaneous Passage of Acutely Obstructing Ureteral Calculi in Medical Expulsive Therapy

Ureteral calculi, commonly known as kidney stones, are a frequent cause of Emergency Department (ED) visits. These stones can get caught in the ureter (the tube connecting the kidney to the bladder) and cause symptoms including pain, nausea, and vomiting. As long as the obstructing stone meets certain conditions and the patient isn't too sick, the patient is usually sent home to try and pass the stone without surgery. This treatment is known as medical expulsive therapy (MET), and routinely involves the use of a drug called tamsulosin, which relaxes the smooth muscle of the urinary system to help the stone pass. Silodosin is a drug in the same class of tamsulosin, but which is thought to have a more selective action and a quicker onset, which would theoretically make it better for aiding in kidney stone passage. The purpose of this study is a head-to-head, blinded comparison of these two drugs to see how quickly they result in stone passage. Subjects are patients presenting to the ED with acute kidney stone shown by CT scan, and who are appropriate for MET. The main study intervention is randomization to receiving either tamsulosin or silodosin. The hypothesis is that silodosin will have decreased time to stone passage compared to tamsulosin.

Subjects who qualify and consent are randomized to a two-week course of either silodosin or tamsulosin. They are also given prescriptions for standard of care medications for pain and nausea, as well as a pain diary. They receive a follow-up phone call after one week to remind them of their follow-up appointment, ask about adverse events, and determine if their stone has passed. They have a follow-up visit with study staff at the end of their two week treatment to collect their pain diary, pill count, adverse events, and to determine if their stone has passed. Study participation ends after this follow-up visit.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Procedures Involved in the Research. This study is a prospective, randomized, double-blinded, head-to-head trial comparing two medications. Patients with symptoms of renal colic who present to the emergency department will be evaluated by the ED staff as per usual routine. After a work-up (including routine chemistry, complete blood count, urine analysis, urine culture, and non-contrast CT scan of the abdomen and pelvis) has been completed, patients who meet inclusion criteria will be asked whether they are willing to enroll in the study. Those who are unsuitable for the study or unwilling to participate will continue to receive routine care for their ureteral calculus. Those who consent will be enrolled as subjects in the study, and given a 2-week supply of either tamsulosin or silodosin in blinded bottles with the appropriate dosing instructions. The prescriptions will be dispensed by the pharmacy; therefore the subjects and study staff will be blinded to which prescription the subject receives. Randomization will be done in advance and a key made to correlate subject enrollment number with which prescription they have received. Throughout the study, the study staff will make no efforts to ascertain which medication the subject has been given, unless an adverse event is suspected. Each participant will be given an information card that details the two possible medications they are taking, which can be presented to their physicians as needed.

Subjects will then be discharged to home as per routine care with instructions to drink plenty of fluids, and will be given a strainer and asked to attempt to catch their ureteral calculus. They will also be given a standardized prescription analgesic package (Percocet 5/325mg #20, Motrin 600mg #60, Zofran OD 4mg #20 with standard dosing instructions) and a Visual Analog Pain Scale diary to be filled out daily. Subjects will be given standardized discharge instructions as per standard of care that will include indications for immediate ED return for signs and symptoms of infection or MET failure (fever, worsening pain, vomiting, lethargy, unsteadiness, syncope or inability to tolerate oral pain medications). As per standard of care, they will be instructed to return to the ER immediately if they develop any of these symptoms. Finally, the subject's contact information will be collected at the time of enrollment and a follow-up appointment will be scheduled for them with Urology in 4 weeks to ensure they get appropriate and timely specialty follow-up. This follow-up is also standard of care, and will occur after the subject's participation in the study ends.

Each subject will be scheduled to return to the ER in 2 weeks to be seen by the research staff for data collection. They will be asked to bring their pill bottle and visual analog pain scale diary to this visit. If the subject reports having passed a stone consistent with their initial imaging, or have resolution of their pain to suggest they passed the stone unseen, this will conclude their participation in the study. However, if they are still having symptoms, their case will be categorized as an outpatient treatment failure and the subject will be registered to be seen by an ER Physician and a Urology consult will be ordered, concluding their participation in the study. This is current standard of care, and will be covered by insurance. Any subject that has an unscheduled visit to an ER for a ureterolithiasis-related complaint will also be considered an outpatient treatment failure. This will also conclude their participation in this study.

To ensure follow-up, subjects will be called one week after enrollment. They will be reminded of their 2-week follow-up appointment and the need to bring in their pill bottles. Each subject will also be asked if they have passed the stone or had resolution of the pain. The will be reminded that they must follow-up even if they are no longer having symptoms.

Study Type

Interventional

Enrollment (Actual)

1

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Medical Center Philadelphia

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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults age 18 to 70 years
  • Non-diabetic
  • Unilateral ureteral calculus 4 to 10 mm visible on CT scan within the ureter
  • Serum creatinine level within normal range
  • Ability to tolerate oral fluids and oral pain medication
  • Ability to make informed medical decisions regarding consent
  • Willingness to follow up in the ER in two weeks

Exclusion Criteria:

  • Adults unable to consent
  • Age <18
  • Signs of infection including Temperature >38º C or Urinalysis with any of the following: Positive Leukocyte Esterase, Positive Nitrates, or White Blood Cell Count >5/hfp in the setting of a positive urine culture (defined as a single isolated bacterial species population of >100,000 CFU)
  • Patients with chronic pain already undergoing treatment with narcotic medications
  • Patients already taking an alpha adrenergic antagonist medication
  • Pregnant women
  • Prisoners
  • No working phone number

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Silodosin
Subjects in the Silodosin Group will be given silodosin 8 mg tablets, one tablet to be taken PO each day for two weeks.
Drug: Silodosin
8mg tablet, 1 tab PO daily for 2 weeks
Other Names:
  • Rapaflo
Active Comparator: Tamsulosin
Subjects in the Tamsulosin Group will be given tamsulosin 0.4 mg tablets, one tablet to be taken PO each day for two weeks.
Drug: Tamsulosin
0.4 mg Tab, 1 tab PO daily for 2 weeks
Other Names:
  • Flomax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Stone Passage
Time Frame: at 2 weeks
The primary outcome measure will be the time it takes for the stone to pass. Stone passage will be defined as the subject self-reporting passage of a stone that is consistent with their imaging, or resolution of their pain to suggest unseen passage of their stone. This outcome will be measured from the initial emergency department visit, and gathered at the one-week follow-up call as well as the two-week follow-up visit.
at 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of Pain Medication
Time Frame: at 2 weeks
The subject will be given a standardized pain medication prescription at their initial visit, and will be asked to keep track of how much pain medication they used each day, as well as to bring their pill bottle with them to the two-week follow-up appointment for a pill count. This information will be collected at the two-week follow-up appointment.
at 2 weeks
Outpatient Treatment Failure
Time Frame: at 2 weeks

Subjects will be given instructions at the initial visit to return to the emergency department immediately for signs and symptoms of infection or MET failure (fever, worsening pain, vomiting, lethargy, unsteadiness, syncope or inability to tolerate oral pain medications). These subjects will be considered to have failed outpatient treatment and will be removed from the study.

Subjects who do not experience these issues but who still report having symptoms at the two-week follow-up visit will also be considered to have failed outpatient treatment.
at 2 weeks
Adverse Hemodynamic Reaction
Time Frame: at 2 weeks
Both tamsulosin and silodosin carry the possibility of causing orthostatic hypotension, which can manifest as unsteadiness, syncope, headache, and/or dizziness, especially when changing position from sitting/laying to standing. Subjects will be asked to assess themselves for these symptoms continuously from the initial visit, with serious reactions resulting in cessation of study medication. For reactions which are not serious, the information will be collected at the one-week follow-up call as well as the two-week follow-up visit.
at 2 weeks

Collaborators and Investigators

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

Sponsor

Albert Einstein Healthcare Network

Investigators

  • Principal Investigator: William Boroughf, DO, Einstein Healthcare Network
  • Principal Investigator: James Gardner, MD, Einstein Healthcare Network

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

March 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 19, 2014

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN 4441

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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