Medical Expulsive Therapy of Single Distal Ureteral Stones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00831701
Recruitment Status : Completed
First Posted : January 29, 2009
Results First Posted : May 12, 2010
Last Update Posted : May 25, 2010
Information provided by:
University of Zurich

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Tamsulosin
Tamsulosin treatment
Drug: Tamsulosin
0.4 mg Tamsulosin once daily for 21 days
Other Names:
  • Pradif
  • Flomax

Placebo Comparator: Placebo
Placebo treatment
Drug: Placebo
One placebo pill per day for 21 days or until stone expulsion

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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).

  4. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00831701

Department of Urology, University Hospital Zürich, Switzerland
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Räto T. Strebel, Department of Urology, University Hospital Zürich, switzerland Identifier: NCT00831701     History of Changes
Other Study ID Numbers: 1-Hermanns
First Posted: January 29, 2009    Key Record Dates
Results First Posted: May 12, 2010
Last Update Posted: May 25, 2010
Last Verified: May 2010

Keywords provided by University of Zurich:
Adrenergic alpha antagonists
drug therapy

Additional relevant MeSH terms:
Ureteral Calculi
Pathological Conditions, Anatomical
Ureteral Diseases
Urologic Diseases
Urinary Calculi
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents