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
Current therapeutic options for ureteral stones include active intervention as well as conservative "watch and wait" approaches. Endoscopic treatment of ureteral stones has a high success rate and reliably results in immediate stone removal However, surgical as well as anaesthetic risks are not negligible and serious complications are possible. For many patients, a conservative treatment is an appealing option. Watchful waiting, however, not always results in stone clearance and may be associated with recurrent renal colics.
The therapeutic potential of alpha-blockers for ureteral stone disease has been investigated prompted by the detection of alpha-receptors in ureteral smooth muscle cells. Blocking of such receptors, which are predominantly located in the distal part of the ureter results in relaxation of the ureteral wall and modulation of peristaltic activity. This mechanism has been proposed to facilitate stone passage for ureteral calculi.
Numerous clinical trials have revealed a significant improvement of the stone expulsion rate using the alpha-blocker tamsulosin. Most of these studies were randomised but none were performed in a double-blind and placebo-controlled fashion. Therefore, the objective of this trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a randomised, double-blind, placebo-controlled setting.
|Condition or disease||Intervention/treatment||Phase|
|Ureteral Calculi||Drug: Tamsulosin Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Medical Expulsive Therapy of Single Distal Ureteral Stones. A Randomised, Double-blind and Placebo-controlled Study|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Active Comparator: Tamsulosin
0.4 mg Tamsulosin once daily for 21 days
Placebo Comparator: Placebo
One placebo pill per day for 21 days or until stone expulsion
- Number of Participants With Stone Expulsion [ Time Frame: 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).
- Time to Stone Passage [ Time Frame: 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.
- Required Analgesics [ Time Frame: 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
- Maximum Daily Pain Score [ Time Frame: 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).
- Number of Participants Requiring Active Treatment [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831701
|Department of Urology, University Hospital Zürich, Switzerland|
|Zurich, Switzerland, 8091|
|Study Director:||01 Studienregister MasterAdmins||UniversitaetsSpital Zuerich|