The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients

• Sponsor: Robert Swor (Other)
• Overall Status: Completed
• CT.gov ID: NCT00448123
• Collaborator: William Beaumont Hospitals (Other)
• Enrollment: 127
• Location: 1
• Arms: 2
• Duration (Months): 55
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

To determine if emergency department patients with acute ureteral colic pain due to a ureteral stone who are treated with tamsulosin, versus placebo, will experience a shorter time to passage of their stone or resolution of their pain. A secondary study objective will be to determine if there is a relationship between response to tamsulosin and stone size or position in the ureter.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stones; Ureteral Stones	Drug: Tamsulosin; Drug: Placebo	N/A

Detailed Description

This is a prospective randomized placebo controlled study of tamsulosin alone, vs placebo, to determine its effect on the rates of stone passage and resolution of pain in patients with acute renal colic pain that present to the emergency department. The study will be conducted in the Emergency Department (ED)and Emergency Department Observation Unit (EDOU) of William Beaumont Hospital, a high volume, university affiliated 952 bed suburban teaching hospital.

Patients will be given a seven-day supply of tamsulosin (0.4mg daily) or placebo. They will also be given a prescription for Vicodin (30 pills) and Ibuprofen (600mg, 30 pills). They will be called on days 1, 2, 3, 7, and 10 following the index visit regarding passage of stone or 48 hours without pain. Patients will be asked to call in if they pass their stone or are without pain for 48 hours. Related return visits to Royal Oak or Troy Beaumont within 30 days of their index visit will be followed by chart review.

The study will be limited to patients presenting to the emergency department with acutely symptomatic renal colic pain. Confirmation of a symptomatic stone will be made by imaging (helical CT scan or intravenous pyelogram).

Study exclusion criteria:

• Stone not documented on imaging

• Stones >10mm

• Pregnancy

• Age <18 years

• Evidence of infection with an obstructing stone

• Obstructing stone in a solitary kidney

• Currently taking tamsulosin, vardenafil, nifedipine, or steroids

• Contraindications or allergy to tamsulosin

• Ureteral surgery

• Patients that are unable to understand consent

• Patients that are unable to comply with follow-up

Study Design

• Study Type: Interventional
• Actual Enrollment: 127 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo	Drug: Placebo; Placebo
Active Comparator: Tamsulosin Intervention - Tamsulosin	Drug: Tamsulosin; Study Drug; Other Names: Flomax

Outcome Measures

Primary Outcome Measures

1. Stone Passage [1-7 days]

   Participants were asked during the follow-up phone call to indicate if their stone had passed within seven days. Phone calls were conducted at days 1, 2, 3, 7, 10 and 30 days after the emergency department discharge. Data is reported based on the information obtained up to the 7th day.

Secondary Outcome Measures

1. Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge [1-7 days]

2. High Pain Score by Treatment Group [7 Days]

   Severity of Patient Pain at 7 days Post Emergency Department Visit. Patients were asked to describe their pain severity at each followup phone call, using a numerical scale, ranging from 0 (no pain) to 10 (worst possible pain). We report this measure at 7 days.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Emergency Department patients with acutely symptomatic renal colic pain

• Confirmation of a symptomatic stone will be made by imaging (helical CT scan or intravenous pyelogram).

Exclusion Criteria:

• Stones not documented on imaging

• Stones >10mm

• Pregnancy

• Age <18 years

• Evidence of infection with an obstructing stone

• Obstructing stone in a solitary kidney

• Currently taking tamsulosin, vardenafil, nifedipine, or steroids

• Contraindications or allergy to tamsulosin

• Ureteral surgery

• Patients that are unable to understand consent

• Patients that are unable to comply with follow-up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	William Beaumont Hospital	Royal Oak	Michigan	United States	48073

Sponsors and Collaborators

• Robert Swor
• William Beaumont Hospitals

Investigators

• Principal Investigator: Swor Robert, DO, William Beaumont Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert Swor, Principal Investigator, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT00448123
• Other Study ID Numbers: 2005-107
• First Posted: Mar 15, 2007
• Last Update Posted: Oct 12, 2016
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Robert Swor, Principal Investigator, William Beaumont Hospitals: Kidney Stones; Ureteral Stones; Flomax; Emergency Medicine; Urology
• Additional relevant MeSH terms: Kidney Calculi; Nephrolithiasis; Ureteral Calculi; Ureterolithiasis; Emergencies; Calculi; Tamsulosin

Study Results

Participant Flow

Recruitment Details	127 subjects were enrolled in the study and 100 completed the study. Of the 27 that were excluded from analysis, 15 were excluded due to 'lost to follow-up', and another 12 had their stone removed surgically (physician decision) by the 7th day.

Arm/Group Title	Placebo	Tamsulosin
Arm/Group Description	None active placebo orally per day for up to 10 days.	Tamsulosin orally 0.4 mg/daily for up to 10 days.
Period Title: Overall Study
STARTED	62	65
COMPLETED	47	53
NOT COMPLETED	15	12

Baseline Characteristics

Arm/Group Title	Placebo	Tamsulosin	Total
Arm/Group Description	Placebo Group	Intervention - Tamsulosin Tamsulosin: Study Drug	Total of all reporting groups
Overall Participants	62	65	127
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	62 100%	65 100%	127 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	23 37.1%	23 35.4%	46 36.2%
Male	39 62.9%	42 64.6%	81 63.8%
Region of Enrollment (participants) [Number]
United States	62 100%	65 100%	127 100%

Outcome Measures

1. Primary Outcome

Title	Stone Passage
Description	Participants were asked during the follow-up phone call to indicate if their stone had passed within seven days. Phone calls were conducted at days 1, 2, 3, 7, 10 and 30 days after the emergency department discharge. Data is reported based on the information obtained up to the 7th day.
Time Frame	1-7 days

Outcome Measure Data

Analysis Population Description

In the placebo group, of the 47 subjects 18 (46.2%) passed their stone by Day 7. In the Tamsulosin group, of the 53 subjects 21 (53.9%) passed their stone by Day 7.

Arm/Group Title	Placebo	Tamsulosin
Arm/Group Description	Placebo Group	Intervention - Tamsulosin Tamsulosin: Study Drug
Measure Participants	47	53
Number [participants]	18 29%	21 32.3%

2. Secondary Outcome

Title	Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge
Time Frame	1-7 days

Outcome Measure Data

Analysis Population Description

The data table is limited to the information collected at Day 7. Of the 53 subjects in the placebo group only 29 provided information regarding pain medication at the Day 7 interview. For the Tamsulosin group, only 15 out of 47 provided the pain medication information at the Day 7 interview. At Day 7 each group had only 3 non-zero responses.

Arm/Group Title	Placebo	Tamsulosin
Arm/Group Description	Active placebo orally per day for up to 10 days.	Tamsulosin orally 0.4 mg/daily for up to 10 days.
Measure Participants	29	15
Mean (Full Range) [Pain tablets]	0.4	0.6

3. Secondary Outcome

Title	High Pain Score by Treatment Group
Description	Severity of Patient Pain at 7 days Post Emergency Department Visit. Patients were asked to describe their pain severity at each followup phone call, using a numerical scale, ranging from 0 (no pain) to 10 (worst possible pain). We report this measure at 7 days.
Time Frame	7 Days

Outcome Measure Data

Analysis Population Description

The data table is limited to the information collected at Day 7. Of the 53 subjects in the placebo group only 29 provided information at the Day 7 interview. For the Tamsulosin group, only 15 out of 47 provided information at the Day 7 interview.

Arm/Group Title	Placebo	Tamsulosin
Arm/Group Description	Placebo Placebo: Placebo	Intervention - Tamsulosin Tamsulosin: Study Drug
Measure Participants	29	15
Mean (Full Range) [units on a scale]	1.69	2.4

Adverse Events

Arm/Group Title	Placebo		Tamsulosin
Arm/Group Description	Placebo Group		Intervention - Tamsulosin Tamsulosin: Study Drug
All Cause Mortality
	Placebo		Tamsulosin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Tamsulosin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		0/53 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Tamsulosin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/47 (10.6%)		4/53 (7.5%)
Nervous system disorders
Dizziness	5/47 (10.6%)		4/53 (7.5%)

Limitations/Caveats

Limitations of this study include non-consecutive enrollment and small sample size.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.