Trial Outcomes & Findings for Medical Expulsive Therapy of Single Distal Ureteral Stones (NCT NCT00831701)

Results Overview

The primary end point was the number of patients per group experiencing stone expulsion until day 21, as confirmed by low-dose abdominal computed tomography (CT).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

21 days

Results posted on

2010-05-25

Participant Flow

Randomisation of 100 pts between 09.2006 and 09.2008 in a University Hospital

10 patients were excluded from the final analysis due to stone expulsion before medication intake or withdrew of consent

Participant milestones

Participant milestones
Measure	Tamsulosin Treatment Patients received one pill of Tamsulosin 400 micrograms once daily	Placebo Treatment Patients received Placebo pill once daily
Overall Study STARTED	50	50
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Tamsulosin Treatment Patients received one pill of Tamsulosin 400 micrograms once daily	Placebo Treatment Patients received Placebo pill once daily
Overall Study Withdrawal by Subject	2	0
Overall Study Stone expulsion before first medication	2	2
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

Medical Expulsive Therapy of Single Distal Ureteral Stones

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tamsulosin Treatment n=50 Participants Patients received one pill of Tamsulosin 400 micrograms once daily	Placebo Treatment n=50 Participants Patients received Placebo pill once daily	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	45 Participants n=7 Participants	93 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Age Continuous	38.2 years STANDARD_DEVIATION 12.7 • n=5 Participants	43.4 years STANDARD_DEVIATION 13.9 • n=7 Participants	40.8 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	39 Participants n=7 Participants	81 Participants n=5 Participants
Region of Enrollment Switzerland	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

The primary end point was the number of patients per group experiencing stone expulsion until day 21, as confirmed by low-dose abdominal computed tomography (CT).

Outcome measures

Outcome measures
Measure	Tamsulosin Treatment n=45 Participants Patients received one pill of Tamsulosin 400 micrograms once daily	Placebo Treatment n=45 Participants Patients received Placebo pill once daily
Number of Participants With Stone Expulsion	39 Participants	40 Participants

SECONDARY outcome

Timeframe: 21 days

The patient-defined time of stone expulsion was considered the event for time to stone passage. Patients with unnoticed stone expulsion were censored at the date of last positive stone status, and those who discontinued the therapy were censored at the date of last medication intake. Kaplan-Meier estimates were computed for time to stone passage.

Outcome measures

Outcome measures
Measure	Tamsulosin Treatment n=45 Participants Patients received one pill of Tamsulosin 400 micrograms once daily	Placebo Treatment n=45 Participants Patients received Placebo pill once daily
Time to Stone Passage	7 days Interval 3.0 to 10.0	10 days Interval 3.0 to 20.0

SECONDARY outcome

Timeframe: Until stone expulsion or up to 21 days

Oral diclophenac (up to 3x50 mg pills) as first-line and oral metamizole (up to 8x 500mg pills)as second-line on-demand analgesics were prescribed. All patients were requested to record the required amount of pills per day

Outcome measures

Outcome measures
Measure	Tamsulosin Treatment n=45 Participants Patients received one pill of Tamsulosin 400 micrograms once daily	Placebo Treatment n=45 Participants Patients received Placebo pill once daily
Required Analgesics	3 pills per day Interval 1.0 to 9.8	7 pills per day Interval 4.0 to 16.0

SECONDARY outcome

Timeframe: Until stone expulsion or up to 21 days

All patients kept a diary to record the score of every painful episode on a 10-cm visual analogue scale (0= no pain at all; 10= strongest pain one can imagine).

Outcome measures

Outcome measures
Measure	Tamsulosin Treatment n=45 Participants Patients received one pill of Tamsulosin 400 micrograms once daily	Placebo Treatment n=45 Participants Patients received Placebo pill once daily
Maximum Daily Pain Score	3 Units on a scale Interval 0.0 to 10.0	7 Units on a scale Interval 0.0 to 9.0

SECONDARY outcome

Timeframe: 21 days

The number of participants requiring active treatment was recorded. Shock wave lithotrypsy (SWL), ureterorenoscopy (URS) or insertion of an ureteral catheter were considered as active treatment.

Outcome measures

Outcome measures
Measure	Tamsulosin Treatment n=45 Participants Patients received one pill of Tamsulosin 400 micrograms once daily	Placebo Treatment n=45 Participants Patients received Placebo pill once daily
Number of Participants Requiring Active Treatment	6 participants	4 participants

Adverse Events

Tamsulosin Treatment

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tamsulosin Treatment n=45 participants at risk Patients received one pill of Tamsulosin 400 micrograms once daily	Placebo Treatment n=45 participants at risk Patients received Placebo pill once daily
Reproductive system and breast disorders Retrograde ejaculation	4.4% 2/45 • Number of events 2 • 3 weeks	0.00% 0/45 • 3 weeks
Gastrointestinal disorders Diarrhoea	2.2% 1/45 • Number of events 1 • 3 weeks	0.00% 0/45 • 3 weeks
Skin and subcutaneous tissue disorders Cutaneous reaction (mild)	2.2% 1/45 • Number of events 1 • 3 weeks	0.00% 0/45 • 3 weeks
General disorders Dizziness	0.00% 0/45 • 3 weeks	2.2% 1/45 • Number of events 1 • 3 weeks

Additional Information

Räto T. Strebel

Department of Urology, University Hospital Zürich, Switzerland

Phone: 0041-44-2551111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place