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.

Study Overview

• Status: Completed
• Conditions: Ureteral Calculi
• Intervention / Treatment: Drug: Tamsulosin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Department of Urology, University Hospital Zürich, Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Tamsulosin; Tamsulosin treatment	Drug: Tamsulosin; 0.4 mg Tamsulosin once daily for 21 days; Other Names: Flomax; Pradif
PLACEBO_COMPARATOR: Placebo; Placebo treatment	Drug: Placebo; One placebo pill per day for 21 days or until stone expulsion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Stone Expulsion	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).	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Stone Passage	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.	21 days
Required Analgesics	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	Until stone expulsion or up to 21 days
Maximum Daily Pain Score	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).	Until stone expulsion or up to 21 days
Number of Participants Requiring Active Treatment	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.	21 days

Collaborators and Investigators

• Sponsor: University of Zurich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (ACTUAL): November 1, 2008
• Study Completion (ACTUAL): November 1, 2008

Study Registration Dates

• First Submitted: November 19, 2008
• First Submitted That Met QC Criteria: January 28, 2009
• First Posted (ESTIMATE): January 29, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 25, 2010
• Last Update Submitted That Met QC Criteria: May 19, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: ureter; drug therapy; tamsulosin; Adrenergic alpha antagonists
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Ureteral Calculi; Ureterolithiasis; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: 1-Hermanns