Medical Expulsive Therapy of Single Distal Ureteral Stones

Ureteral Calculi Clinical Trial

Official title:

Medical Expulsive Therapy of Single Distal Ureteral Stones. A Randomised, Double-blind and Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831701
• Other study ID #: 1-Hermanns
• Status: Completed
• Phase: N/A
• First received: November 19, 2008
• Last updated: May 19, 2010
• Start date: September 2006
• Est. completion date: November 2008

Study information

• Verified date: May 2010
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ureteral Calculi
• Ureterolithiasis

Intervention

Drug:
• Tamsulosin
0.4 mg Tamsulosin once daily for 21 days
• Placebo
One placebo pill per day for 21 days or until stone expulsion

Locations

Country	Name	City	State
Switzerland	Department of Urology, University Hospital Zürich, Switzerland	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes