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N/A N=100 Randomized Quadruple-blind Treatment

Medical Expulsive Therapy of Single Distal Ureteral Stones

Ureteral Calculi

Enrolled (actual)
100
Serious AEs
0.0%
Results posted
May 2010
Primary outcome: Primary: Number of Participants With Stone Expulsion — 39; 40 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Tamsulosin (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Zurich
Primary completion
Nov 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Stone Expulsion
39; 40
SECONDARY
Time to Stone Passage
7; 10
SECONDARY
Required Analgesics
3; 7
SECONDARY
Maximum Daily Pain Score
3; 7
SECONDARY
Number of Participants Requiring Active Treatment
6; 4

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00831701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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