Medical Expulsive Therapy of Single Distal Ureteral Stones

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00831701
First received: November 19, 2008
Last updated: May 19, 2010
Last verified: May 2010

November 19, 2008
May 19, 2010
September 2006
November 2008   (final data collection date for primary outcome measure)
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).
expulsion rate [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00831701 on ClinicalTrials.gov Archive Site
  • 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.
  • Time top stone passage [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • required analgesics [ Time Frame: until stone expulsion ] [ Designated as safety issue: Yes ]
  • maximum pain score per day [ Time Frame: until stone expulsion ] [ Designated as safety issue: Yes ]
  • maximum daily pain score [ Time Frame: until stone expulsion ] [ Designated as safety issue: Yes ]
  • intervention rate [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Medical Expulsive Therapy of Single Distal Ureteral Stones
Medical Expulsive Therapy of Single Distal Ureteral Stones. A Randomised, Double-blind and Placebo-controlled Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ureteral Calculi
  • Drug: Tamsulosin
    0.4 mg Tamsulosin once daily for 21 days
    Other Names:
    • Pradif
    • Flomax
  • Drug: Placebo
    One placebo pill per day for 21 days or until stone expulsion
  • Active Comparator: Tamsulosin
    Tamsulosin treatment
    Intervention: Drug: Tamsulosin
  • Placebo Comparator: Placebo
    Placebo treatment
    Intervention: Drug: Placebo
Hermanns T, Sauermann P, Rufibach K, Frauenfelder T, Sulser T, Strebel RT. Is there a role for tamsulosin in the treatment of distal ureteral stones of 7 mm or less? Results of a randomised, double-blind, placebo-controlled trial. Eur Urol. 2009 Sep;56(3):407-12. Epub 2009 Apr 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00831701
1-Hermanns
No
Räto T. Strebel, Department of Urology, University Hospital Zürich, switzerland
University of Zurich
Not Provided
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
University of Zurich
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP