Clinical trial NCT00831701: Medical Expulsive Therapy of Single Distal Ureteral Stones
Official title: Medical Expulsive Therapy of Single Distal Ureteral Stones. A Randomised, Double-blind and Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteral Calculi
Keywords: Adrenergic alpha antagonists
drug therapy
tamsulosin
ureter
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Stone Expulsion
timeFrame: 21 days
Secondary outcomes:
measure: Time to Stone Passage
timeFrame: 21 days
measure: Required Analgesics
timeFrame: Until stone expulsion or up to 21 days
measure: Maximum Daily Pain Score
timeFrame: Until stone expulsion or up to 21 days
measure: Number of Participants Requiring Active Treatment
timeFrame: 21 days
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Urology, University Hospital Zürich, Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1016/j.eururo.2009.03.076. Epub 2009 Apr 3.