Medical Expulsive Therapy of Single Distal Ureteral Stones

NCT00831701 | Completed Results

• 1 other identifier: 1-Hermanns
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Adrenergic alpha antagonists; drug therapy; tamsulosin; ureter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to Stone Passage

  21 days

• Required Analgesics

  Until stone expulsion or up to 21 days

• Maximum Daily Pain Score

  Until stone expulsion or up to 21 days

• Number of Participants Requiring Active Treatment

  21 days

Study Arms (2)

Tamsulosin

ACTIVE COMPARATOR

Tamsulosin treatment

Drug: Tamsulosin

Placebo

PLACEBO COMPARATOR

Placebo treatment

Drug: Placebo

Interventions

Tamsulosin DRUG

0.4 mg Tamsulosin once daily for 21 days

Also known as: Pradif, Flomax

Tamsulosin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with a single 2 to 7mm ureteral stone below the common iliac vessels

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Urology, University Hospital Zürich, Switzerland

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 19375849 DERIVED

MeSH Terms

Conditions

Ureteral Calculi

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Ureterolithiasis; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Limitations and Caveats

Not all patients were able to record the exact time of stone passage. Thus, the secondary end point of time to stone passage is based on Kaplan-Meier estimation.

Results Point of Contact

• Title: Räto T. Strebel
• Organization: Department of Urology, University Hospital Zürich, Switzerland

raeto.strebel@ksgr.ch

0041-44-2551111

Study Officials

• 01 Studienregister MasterAdmins

  UniversitaetsSpital Zuerich

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: January 29, 2009
• Study Start: September 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 25, 2010
• Results First Posted: May 12, 2010

Record last verified: 2010-05

Locations

CH (1)