Medical Expulsive Therapy of Single Distal Ureteral Stones
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Purpose
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 | Intervention |
|---|---|
|
Ureteral Calculi |
Drug: Tamsulosin Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Medical Expulsive Therapy of Single Distal Ureteral Stones. A Randomised, Double-blind and Placebo-controlled Study |
- Number of Participants With Stone Expulsion [ Time Frame: 21 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 100 |
| Study Start Date: | September 2006 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Tamsulosin
Tamsulosin treatment
|
Drug: Tamsulosin
0.4 mg Tamsulosin once daily for 21 days
Other Names:
|
|
Placebo Comparator: Placebo
Placebo treatment
|
Drug: Placebo
One placebo pill per day for 21 days or until stone expulsion
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- patients with a single 2 to 7mm ureteral stone below the common iliac vessels
Exclusion criteria:
- presence of multiple ureteral stones
- renal insufficiency (glomerular filtration rate below 60 ml/min)
- urinary tract infection
- a solitary kidney
- pregnancy
- history of ureteral surgery or previous endoscopic procedure
- hypersensitivity to tamsulosin
- current alpha-blocker, calcium-antagonist or corticosteroid medication
Contacts and Locations| Switzerland | |
| Department of Urology, University Hospital Zürich, Switzerland | |
| Zurich, Switzerland, 8091 | |
| Study Director: | 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich |
More Information
No publications provided by University of Zurich
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| Study First Received: | November 19, 2008 |
| Results First Received: | January 11, 2010 |
| Last Updated: | May 19, 2010 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University of Zurich:
|
Adrenergic alpha antagonists drug therapy tamsulosin ureter |
Additional relevant MeSH terms:
|
Calculi Ureteral Calculi Ureterolithiasis Pathological Conditions, Anatomical Ureteral Diseases Urologic Diseases Urolithiasis Urinary Calculi Adrenergic alpha-Antagonists |
Tamsulosin Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Adrenergic alpha-1 Receptor Antagonists |
ClinicalTrials.gov processed this record on October 18, 2012
