Tamsulosin for Urolithiasis in the Emergency Dept

NCT00382265 | Completed Phase 4 Results DMC

• 4 other identifiers: RO1 DK71603U01DK096037U01DK071603U34DK090957
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 4

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. 1.tamsulosin for a maximum of 28 days;
2. 2.placebo for a maximum of 28 days.
3. 3.to determine if tamsulosin is effective, and
4. 4.to evaluate the safety of the therapy.
5. 5.a reduction in time to pain free recovery and hence a more rapid return to employment;
6. 6.decreased requirements for narcotic analgesia;
7. 7.less need for urological out-patient clinic follow-up;
8. 8.decreased need for surgical intervention or lithotripsy; and
9. 9.substantial cost savings.

Conditions

Ureterolithiases

Keywords

urolithiasis; renal colic; kidney stones; urinary stone disease

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Passing Their Stone Within 28 Days by Self Report

  Hypothesis: The administration of tamsulosin after the clinical and radiographic diagnosis of acute urolithiasis will produce an increase in the proportion of patients passing their stone within 28 days.

  28 days

Secondary Outcomes (5)

• Any Pain Medication

  28 days

• Need for Surgical Intervention

  28 days

• Crossover to Open Label Tamsulosin

  28 days

• Confirmation of Stone Passage on CT

  28 days

• Return to Work (if Employed)

  28 days

Study Arms (2)

Tamsulosin

ACTIVE COMPARATOR

Tamsulosin 0.4mg PO qd for 28 days

Drug: tamsulosin

Placebo

PLACEBO COMPARATOR

Placebo PO qd for 28 days

Other: Placebo

Interventions

tamsulosin DRUG

tamsulosin 0.4mg po qd for 28 days

Tamsulosin

Placebo OTHER

placebo po qd for 28 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Evidence of ureterolithiasis (i.e. stone is located in ureter, not in bladder) as demonstrated on radiographic studies, specifically non-contrast spiral CT.
• Willingness to participate and able to proceed with standard outpatient management (no personal or job-related issues, e.g. airline pilot.
• Has a telephone in order to be contacted for follow-up.

You may not qualify if:

• Patient desiring or requiring immediate surgical intervention making then not a candidate for outpatient kidney stone management.
• Current urinary tract infection based on urine dipstick as admission and urgent procedural management are likely indicated.
• Known anatomical genitourinary abnormalities or prior Genitourinary surgeries.
• Positive pregnancy test making proper radiological imaging contraindicated.
• Breastfeeding mothers.
• History of hypersensitivity to tamsulosin.
• Current use of alpha blockers or calcium channel blockers.
• Current use of steroids which may have an independent effect on stone expulsion.
• Spontaneous stone expulsion prior to enrollment.
• Largest stone dimension ≥ 9mm assessed using radiologic imaging, being very unlikely to pass spontaneously.
• Presence of stone in the bladder.
• Current use of vardenafil which is tamsulosin contraindicated.
• Ipsilateral, transplanted or solitary kidney as hospitalization may be necessary.
• Known renal insufficiency.
• Fever defined as \>101.5°F which may indicate infection.

Sponsors & Collaborators

• Andrew Meltzer: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (4)

University of Alabama - Birmingham

Birmingham, Alabama, 35249, United States

Location

The George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (3)

• 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.

  PMID: 33213185 DERIVED

• 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.

  PMID: 29913020 DERIVED

• 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.

  PMID: 27890522 DERIVED

MeSH Terms

Conditions

Ureterolithiasis; Urolithiasis; Renal Colic; Kidney Calculi

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Andrew Meltzer, MD, MS
• Organization: George Washington University

ameltzer@mfa.gwu.edu

202-741-2952

Study Officials

• Andrew C Meltzer, MD

  The George Washington University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2006
• First Posted: September 29, 2006
• Study Start: January 1, 2008
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: December 10, 2018
• Results First Posted: December 10, 2018

Record last verified: 2018-11

Locations

US (4)