UreterolithiasesPhase 4STONENCT00382265
Tamsulosin for Urolithiasis in the Emergency Dept
A Phase 4 study testing tamsulosin in people with Ureterolithiases, run by Andrew Meltzer at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureterolithiases
- What is being tested?
- tamsulosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 512 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2008to 1 Feb 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- 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.)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Alabama - Birmingham
Birmingham, Alabama, 35249
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
The George Washington University Medical Center
Washington D.C., District of Columbia, 20037
About this study
Official title: Study of Tamsulosin for Urolithiasis in the Emergency Department
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.
Read more
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
- Ureterolithiases
- Being tested
- tamsulosin, Placebo
- Keywords
- urolithiasis, renal colic, kidney stones, urinary stone disease
- Medical subject headings
- Ureterolithiasis, Urolithiasis, Renal Colic, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamsulosinDrug
tamsulosin 0.4mg po qd for 28 days
PlaceboOther
placebo po qd for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Active comparator | Tamsulosin 0.4mg PO qd for 28 days Receives: Drug: tamsulosin |
| Placebo | Placebo comparator | Placebo PO qd for 28 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (5)
Any Pain Medication
Patients on any pain medication at day 28
Measured: 28 days
Need for Surgical Intervention
Measured: 28 days
Crossover to Open Label Tamsulosin
Measured: 28 days
Confirmation of Stone Passage on CT
Measured: 28 days
Return to Work (if Employed)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startJan 2008
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for UreterolithiasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Meltzer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Meltzer, George Washington University
- Investigators
- Andrew C Meltzer, MD, Principal investigator, The George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382265
- Sponsor's protocol ID
- RO1 DK71603
- Other IDs
- U01DK096037, U01DK071603, U34DK090957
- Acronym
- STONE
- Status last verified
- Nov 2018
- First submitted
- 28 Sep 2006
- Last updated
- 10 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 33213185Meltzer 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 29913020Burrows 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 at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Tamsulosin for Urolithiasis in the Emergency Department
- ClinicalTrials.gov ID
- NCT00382265
- Acronym / sponsor ID
- STONE / RO1 DK71603
- Conditions
- Ureterolithiases
- Keywords
- urolithiasis, renal colic, kidney stones, urinary stone disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Andrew MeltzerUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2008
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 29 Sep 2006 (estimated)
- Results
- Posted 10 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Active comparator | Drug: tamsulosinTamsulosin 0.4mg PO qd for 28 days |
| Placebo | Placebo comparator | Other: PlaceboPlacebo PO qd for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tamsulosintamsulosin 0.4mg po qd for 28 days | Drug | Tamsulosin |
| Placeboplacebo po qd for 28 days | Other | Placebo |
Primary outcome
Proportion of Patients Passing Their Stone Within 28 Days by Self Report
Time frame: 28 days
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.
5 secondary outcomes
Any Pain Medication
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 and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33213185Meltzer 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.
- Derived from this study: PubMed 29913020Meltzer 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.
- Derived from this study: PubMed 27890522Burrows 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew C Meltzer, MD principal investigator
The George Washington University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tamsulosin in people with Ureterolithiases, run by Andrew Meltzer at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Passing Their Stone Within 28 Days by Self Report (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00382265, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2018.