Medical Expulsive Therapy of Single Distal Ureteral Stones

University of Zurich (UZH)

Status: Completed

Conditions: Ureteral Calculi

Treatments: Drug: Tamsulosin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00831701

1-Hermanns

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Tamsulosin

Active Comparator group

Description:

Tamsulosin treatment

Treatment:

Drug: Tamsulosin

Placebo

Placebo Comparator group

Description:

Placebo treatment

Treatment:

Drug: Placebo