Tamsulosin for Urolithiasis in the Emergency Dept

NCT ID: NCT00382265

Last Updated: 2018-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 512 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2017-02-01

Brief Summary

Urolithiasis is a disease that effects 12% of the population and its incidence is growing. In the US there are over 1.1 million visits annually to Emergency Departments for renal colic. The disease is extremely painful, often requiring large amounts of narcotic analgesia, and results in lost work days. Moreover, up to 30% of patients may eventually require lithotripsy or surgical removal of the stone. Currently there are no medical interventions other than analgesia which are offered to patients.

Based on encouraging results from several small European clinical studies, the researchers hypothesize that the administration of tamsulosin to patients with symptomatic urolithiasis will enhance stone passage, and reduce both the time to recovery and the need for surgical intervention or lithotripsy. The researchers will conduct a study by identifying and recruiting patients presenting with urolithiasis in the emergency departments of four institutions.

A total of 500 consenting subjects will be randomly assigned to one of two groups:

1. tamsulosin for a maximum of 28 days;

2. placebo for a maximum of 28 days.

In addition, both groups will receive standard analgesic therapy.

The study team, which will be blinded to treatment status, will monitor each subject's clinical progress and outcome. The primary objectives of this study are:

1. to determine if tamsulosin is effective, and

2. to evaluate the safety of the therapy.

Another objective is to identify the most appropriate clinical subgroup(s) for treatment.

If the therapeutic benefits observed in smaller clinical studies are replicated, administration of these medications should produce several benefits, including:

1. a reduction in time to pain free recovery and hence a more rapid return to employment;

2. decreased requirements for narcotic analgesia;

3. less need for urological out-patient clinic follow-up;

4. decreased need for surgical intervention or lithotripsy; and

5. substantial cost savings.

If this therapy is beneficial, it will represent a major advance in the treatment of urolithiasis. This objective is a major stated goal of the NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases) Clinical Urology Program, which has a stated mission to improve the treatment of urolithiasis.

Kidney stones are a major public health issue, and one person in eight will be affected by the disease. If the hypothesis is verified, the researchers will provide the first medical therapy ever for this disease. This therapy, if effective, will reduce the amount of time a patient is off work because of the pain from the disease, and may also reduce the need for expensive and time-consuming surgical treatments.

Conditions

Ureterolithiases

Keywords

urolithiasis; renal colic; kidney stones; urinary stone disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tamsulosin

Tamsulosin 0.4mg PO qd for 28 days

Group Type: ACTIVE_COMPARATOR

tamsulosin

Intervention Type: DRUG

tamsulosin 0.4mg po qd for 28 days

Placebo

Placebo PO qd for 28 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo po qd for 28 days

Interventions

tamsulosin

tamsulosin 0.4mg po qd for 28 days

Intervention Type: DRUG

Placebo

placebo po qd for 28 days

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years

2. Evidence of ureterolithiasis (i.e. stone is located in ureter, not in bladder) as demonstrated on radiographic studies, specifically non-contrast spiral CT.

3. Willingness to participate and able to proceed with standard outpatient management (no personal or job-related issues, e.g. airline pilot.

4. Has a telephone in order to be contacted for follow-up.

Exclusion Criteria

1. Patient desiring or requiring immediate surgical intervention making then not a candidate for outpatient kidney stone management.

2. Current urinary tract infection based on urine dipstick as admission and urgent procedural management are likely indicated.

3. Known anatomical genitourinary abnormalities or prior Genitourinary surgeries.

4. Positive pregnancy test making proper radiological imaging contraindicated.

5. Breastfeeding mothers.

6. History of hypersensitivity to tamsulosin.

7. Current use of alpha blockers or calcium channel blockers.

8. Current use of steroids which may have an independent effect on stone expulsion.

9. Spontaneous stone expulsion prior to enrollment.

10. Largest stone dimension ≥ 9mm assessed using radiologic imaging, being very unlikely to pass spontaneously.

11. Presence of stone in the bladder.

12. Current use of vardenafil which is tamsulosin contraindicated.

13. Ipsilateral, transplanted or solitary kidney as hospitalization may be necessary.

14. Known renal insufficiency.

15. Fever defined as >101.5°F which may indicate infection.

16. Floppy iris syndrome which is tamsulosin contraindicated.

17. Planned cataract surgery in the next 60 days which is tamsulosin contraindicated.

18. Prisoners /wards of state.

19. Prior enrollment in STONE (Candidates who are screened and found ineligible may be rescreened at a later date.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Andrew Meltzer

OTHER

Sponsor Role: lead

Responsible Party

Andrew Meltzer

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrew C Meltzer, MD

Role: PRINCIPAL_INVESTIGATOR

The George Washington University

Locations

University of Alabama - Birmingham

Birmingham, Alabama, United States

The George Washington University Medical Center

Washington D.C., District of Columbia, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Meltzer AC, Wolfson AB, Mufarrij P, MacPherson C, Montano N, Kirkali Z, Burrows PK, Jackman SV. Analgesic and Opioid Use for Patients Discharged from the Emergency Department with Ureteral Stones. J Endourol. 2021 Jul;35(7):1067-1071. doi: 10.1089/end.2020.0835. Epub 2021 Jan 21.

Reference Type: DERIVED

PMID: 33213185 (View on PubMed)

Meltzer AC, Burrows PK, Wolfson AB, Hollander JE, Kurz M, Kirkali Z, Kusek JW, Mufarrij P, Jackman SV, Brown J. Effect of Tamsulosin on Passage of Symptomatic Ureteral Stones: A Randomized Clinical Trial. JAMA Intern Med. 2018 Aug 1;178(8):1051-1057. doi: 10.1001/jamainternmed.2018.2259.

Reference Type: DERIVED

PMID: 29913020 (View on PubMed)

Burrows PK, Hollander JE, Wolfson AB, Kurz MC, Richards L, DiFiore S, Watts P, Patkar N, Brown J, Jackman S, Kirkali Z, Kusek JW, Michel C, Meltzer AC; STONE Study Investigators. Design and challenges of a randomized clinical trial of medical expulsive therapy (tamsulosin) for urolithiasis in the emergency department. Contemp Clin Trials. 2017 Jan;52:91-94. doi: 10.1016/j.cct.2016.11.010. Epub 2016 Nov 23.

Reference Type: DERIVED

PMID: 27890522 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

U01DK096037

Identifier Type: NIH

Identifier Source: secondary_id

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U01DK071603

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U34DK090957

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RO1 DK71603

Identifier Type: -

Identifier Source: org_study_id