Tamsulosin for Urolithiasis in the Emergency Dept

Ureterolithiases Clinical Trial

— STONE  

Official title:

Study of Tamsulosin for Urolithiasis in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382265
• Other study ID #: RO1 DK71603
• Secondary ID: U01DK096037U01DK
• Status: Completed
• Phase: Phase 4
• Start date: January 2008
• Est. completion date: February 1, 2017

Study information

• Verified date: November 2018
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Emergencies
• Ureteral Calculi
• Ureterolithiases
• Ureterolithiasis
• Urolithiasis

Intervention

Drug:
• tamsulosin
tamsulosin 0.4mg po qd for 28 days

Other:
• Placebo
placebo po qd for 28 days

Locations

Country	Name	City	State
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	The George Washington University Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Andrew Meltzer	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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