Medical Expulsive Therapy of Single Distal Ureteral Stones

NCT ID: NCT00831701

Last Updated: 2010-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-11-30

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.

Conditions

Ureteral Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tamsulosin

Tamsulosin treatment

Group Type: ACTIVE_COMPARATOR

Tamsulosin

Intervention Type: DRUG

0.4 mg Tamsulosin once daily for 21 days

Placebo

Placebo treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One placebo pill per day for 21 days or until stone expulsion

Interventions

Tamsulosin

0.4 mg Tamsulosin once daily for 21 days

Intervention Type: DRUG

Placebo

One placebo pill per day for 21 days or until stone expulsion

Intervention Type: DRUG

Other Intervention Names

Pradif; Flomax

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Department of Urology, University Hospital Zürich, switzerland

Principal Investigators

01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Locations

Department of Urology, University Hospital Zürich, Switzerland

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 19375849 (View on PubMed)

Other Identifiers

1-Hermanns

Identifier Type: -

Identifier Source: org_study_id