CompletedNCT00382265STONEUpdated Dec 10, 2018Results posted

Tamsulosin for Urolithiasis in the Emergency Dept

A Phase 4 interventional study of tamsulosin and Placebo in Ureterolithiases, sponsored by Andrew Meltzer. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-10.

Sponsored by Andrew Meltzer · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 512
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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:

tamsulosin for a maximum of 28 days;
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:

to determine if tamsulosin is effective, and
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:

a reduction in time to pain free recovery and hence a more rapid return to employment;
decreased requirements for narcotic analgesia;
less need for urological out-patient clinic follow-up;
decreased need for surgical intervention or lithotripsy; and
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 studied

Ureterolithiases

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Keywords

urolithiasis
renal colic
kidney stones
urinary stone disease

In context

Ureterolithiasis

84 studies on the registry are indexed under Ureterolithiasis; 19 are open to participants now.

This study's enrollment of 512 is above the median of 101 across 66 interventional studies indexed under Ureterolithiasis.

Browse Ureterolithiasis studies →

Lead sponsor

Andrew Meltzer is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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 .
Breastfeeding mothers.
History of to tamsulosin.
Current use of alpha blockers or calcium channel blockers.
Current use of 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.
Floppy iris syndrome which is tamsulosin contraindicated.
Planned cataract surgery in the next 60 days which is tamsulosin contraindicated.
Prisoners /wards of state.
Prior enrollment in STONE (Candidates who are screened and found ineligible may be rescreened at a later date.)

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 512 participants (actual)

Study arms

Active comparator
Tamsulosin
Tamsulosin 0.4mg PO qd for 28 days
Drug: tamsulosin
Placebo comparator
Placebo
Placebo PO qd for 28 days
Other: Placebo

Interventions

Drugtamsulosin
tamsulosin 0.4mg po qd for 28 days
OtherPlacebo
placebo po qd for 28 days

What researchers measure

Primary outcomes

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.
Time frame: 28 days

Secondary outcomes

Any Pain Medication
Patients on any pain medication at day 28
Time frame: 28 days
Need for Surgical Intervention
Time frame: 28 days
Crossover to Open Label Tamsulosin
Time frame: 28 days
Confirmation of Stone Passage on CT
Time frame: 28 days
Return to Work (if Employed)
Time frame: 28 days

Results

Posted Dec 10, 2018

Participant flow

Participant flow — Overall Study
Milestone	Active Comparator:1	Placebo Comparator:2
Started	267	245
Completed	258	239
Not completed	9	6

Outcome measures

PrimaryProportion 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.

Time frame:: 28 days
Reported as:: Count of participants · Participants

Proportion of Patients Passing Their Stone Within 28 Days by Self Report
Participants	Tamsulosin	Placebo
Proportion of Patients Passing Their Stone Within 28 Days by Self Report	128	113

SecondaryAny Pain Medication

Patients on any pain medication at day 28

Time frame:: 28 days
Reported as:: Count of participants · Participants

Any Pain Medication
Participants	Tamsulosin	Placebo
Any Pain Medication	22	24

SecondaryNeed for Surgical Intervention

Time frame:: 28 days
Reported as:: Count of participants · Participants

Need for Surgical Intervention
Participants	Tamsulosin	Placebo
Need for Surgical Intervention	14	13

SecondaryCrossover to Open Label Tamsulosin

Time frame:: 28 days
Reported as:: Count of participants · Participants

Crossover to Open Label Tamsulosin
Participants	Tamsulosin	Placebo
Crossover to Open Label Tamsulosin	15	14

SecondaryConfirmation of Stone Passage on CT

Time frame:: 28 days
Reported as:: Count of participants · Participants

Confirmation of Stone Passage on CT
Participants	Tamsulosin	Placebo
Confirmation of Stone Passage on CT	102	90

SecondaryReturn to Work (if Employed)

Time frame:: 28 days
Reported as:: Count of participants · Participants

Return to Work (if Employed)
Participants	Tamsulosin	Control Group
Return to Work (if Employed)	202	185

Adverse events

Collected over Adverse event data were collected for 90 days after each patient enrollment in the study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Tamsulosin	0/267 (0%)	0/267 (0%)	0/267 (0%)
Placebo	0/245 (0%)	0/245 (0%)	0/245 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Tamsulosin Group	Placebo Group	Total
Mean	41.8 ± 13.6	39.3 ± 12.9	40.6 ± 13.3

Sex: Female, Male
Sex: Female, Male(Participants)	Tamsulosin Group	Placebo Group	Total
Female	70	69	139
Male	197	176	373

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Tamsulosin Group	Placebo Group	Total
Non-White Race	56	54	110

Region of Enrollment
Region of Enrollment(participants)	Tamsulosin Group	Placebo Group	Total
United States	267	245	512

Study locations

4 sites

University of Alabama - Birmingham
Birmingham, Alabama 35249, United States
The George Washington University Medical Center
Washington, District of Columbia 20037, United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107, United States
University of Pittsburgh
Pittsburgh, Pennsylvania 15261, United States

References and documents

Publications

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. PubMed 33213185 ↗
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. PubMed 29913020 ↗
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. PubMed 27890522 ↗

Study documents

Protocol, analysis plan and consent form ↗ · Sep 4, 2015

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2008, a primary completion of Feb 2017 and a completion of Feb 2017. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2018, 1 year 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 28, 2006
First posted: Sep 29, 2006
Start: Jan 2008
Primary completionActual: Feb 1, 2017
CompletionActual: Feb 1, 2017
Results first posted: Dec 10, 2018
Last update: Dec 10, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00382265
Lead sponsor: Andrew Meltzer
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party: Andrew Meltzer (Principal Investigator, George Washington University) — Sponsor-investigator
First posted: Sep 29, 2006
Start date: Jan 2008
Primary completion: Feb 1, 2017
Completion: Feb 1, 2017
Results posted: Dec 10, 2018
Last update: Dec 10, 2018

Study contacts

Andrew C Meltzer, MD

principal investigator · The George Washington University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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