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Trial record 7 of 24 for:    "Ureterolithiasis" | "Adrenergic Antagonists"

Medical Expulsive Therapy of Single Distal Ureteral Stones

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ClinicalTrials.gov Identifier: NCT00831701
Recruitment Status : Completed
First Posted : January 29, 2009
Results First Posted : May 12, 2010
Last Update Posted : May 25, 2010
Sponsor:
Information provided by:
University of Zurich

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ureteral Calculi
Interventions Drug: Tamsulosin
Drug: Placebo
Enrollment 100
Recruitment Details Randomisation of 100 pts between 09.2006 and 09.2008 in a University Hospital
Pre-assignment Details 10 patients were excluded from the final analysis due to stone expulsion before medication intake or withdrew of consent
Arm/Group Title Tamsulosin Treatment Placebo Treatment
Hide Arm/Group Description Patients received one pill of Tamsulosin 400 micrograms once daily Patients received Placebo pill once daily
Period Title: Overall Study
Started 50 50
Completed 45 45
Not Completed 5 5
Reason Not Completed
Withdrawal by Subject             2             0
Stone expulsion before first medication             2             2
Lost to Follow-up             1             3
Arm/Group Title Tamsulosin Treatment Placebo Treatment Total
Hide Arm/Group Description Patients received one pill of Tamsulosin 400 micrograms once daily Patients received Placebo pill once daily Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
48
  96.0%
45
  90.0%
93
  93.0%
>=65 years
2
   4.0%
5
  10.0%
7
   7.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
38.2  (12.7) 43.4  (13.9) 40.8  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
8
  16.0%
11
  22.0%
19
  19.0%
Male
42
  84.0%
39
  78.0%
81
  81.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Switzerland Number Analyzed 50 participants 50 participants 100 participants
50 50 100
1.Primary Outcome
Title Number of Participants With Stone Expulsion
Hide Description 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).
Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Treatment Placebo Treatment
Hide Arm/Group Description:
Patients received one pill of Tamsulosin 400 micrograms once daily
Patients received Placebo pill once daily
Overall Number of Participants Analyzed 45 45
Measure Type: Number
Unit of Measure: Participants
39 40
2.Secondary Outcome
Title Time to Stone Passage
Hide Description 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.
Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Treatment Placebo Treatment
Hide Arm/Group Description:
Patients received one pill of Tamsulosin 400 micrograms once daily
Patients received Placebo pill once daily
Overall Number of Participants Analyzed 45 45
Median (Inter-Quartile Range)
Unit of Measure: days
7
(3 to 10)
10
(3 to 20)
3.Secondary Outcome
Title Required Analgesics
Hide Description 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
Time Frame Until stone expulsion or up to 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Treatment Placebo Treatment
Hide Arm/Group Description:
Patients received one pill of Tamsulosin 400 micrograms once daily
Patients received Placebo pill once daily
Overall Number of Participants Analyzed 45 45
Median (Inter-Quartile Range)
Unit of Measure: pills per day
3
(1 to 9.8)
7
(4 to 16)
4.Secondary Outcome
Title Maximum Daily Pain Score
Hide Description 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).
Time Frame Until stone expulsion or up to 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Treatment Placebo Treatment
Hide Arm/Group Description:
Patients received one pill of Tamsulosin 400 micrograms once daily
Patients received Placebo pill once daily
Overall Number of Participants Analyzed 45 45
Median (Full Range)
Unit of Measure: Units on a scale
3
(0 to 10)
7
(0 to 9)
5.Secondary Outcome
Title Number of Participants Requiring Active Treatment
Hide Description 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.
Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Treatment Placebo Treatment
Hide Arm/Group Description:
Patients received one pill of Tamsulosin 400 micrograms once daily
Patients received Placebo pill once daily
Overall Number of Participants Analyzed 45 45
Measure Type: Number
Unit of Measure: participants
6 4
Time Frame 3 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tamsulosin Treatment Placebo Treatment
Hide Arm/Group Description Patients received one pill of Tamsulosin 400 micrograms once daily Patients received Placebo pill once daily
All-Cause Mortality
Tamsulosin Treatment Placebo Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tamsulosin Treatment Placebo Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/45 (0.00%)      0/45 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.1%
Tamsulosin Treatment Placebo Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/45 (8.89%)      1/45 (2.22%)    
Gastrointestinal disorders     
Diarrhoea   1/45 (2.22%)  1 0/45 (0.00%)  0
General disorders     
Dizziness   0/45 (0.00%)  0 1/45 (2.22%)  1
Reproductive system and breast disorders     
Retrograde ejaculation  [1]  2/45 (4.44%)  2 0/45 (0.00%)  0
Skin and subcutaneous tissue disorders     
Cutaneous reaction (mild)   1/45 (2.22%)  1 0/45 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
R.E. during medication
Not all patients were able to record the exact time of stone passage. Thus, the secondary end point of time to stone passage is based on Kaplan-Meier estimation.
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Name/Title: Räto T. Strebel
Organization: Department of Urology, University Hospital Zürich, Switzerland
Phone: 0041-44-2551111
Responsible Party: Räto T. Strebel, Department of Urology, University Hospital Zürich, switzerland
ClinicalTrials.gov Identifier: NCT00831701     History of Changes
Other Study ID Numbers: 1-Hermanns
First Submitted: November 19, 2008
First Posted: January 29, 2009
Results First Submitted: January 11, 2010
Results First Posted: May 12, 2010
Last Update Posted: May 25, 2010