Medical Expulsive Therapy of Single Distal Ureteral Stones

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00831701
First received: November 19, 2008
Last updated: May 19, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention
Ureteral Calculi
Drug: Tamsulosin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medical Expulsive Therapy of Single Distal Ureteral Stones. A Randomised, Double-blind and Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Number of Participants With Stone Expulsion [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Time to Stone Passage [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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.

  • Required Analgesics [ Time Frame: Until stone expulsion or up to 21 days ] [ Designated as safety issue: No ]
    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

  • Maximum Daily Pain Score [ Time Frame: Until stone expulsion or up to 21 days ] [ Designated as safety issue: Yes ]
    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).

  • Number of Participants Requiring Active Treatment [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 100
Study Start Date: September 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tamsulosin
Tamsulosin treatment
Drug: Tamsulosin
0.4 mg Tamsulosin once daily for 21 days
Other Names:
  • Pradif
  • Flomax
Placebo Comparator: Placebo
Placebo treatment
Drug: Placebo
One placebo pill per day for 21 days or until stone expulsion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831701

Locations
Switzerland
Department of Urology, University Hospital Zürich, Switzerland
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Räto T. Strebel, Department of Urology, University Hospital Zürich, switzerland
ClinicalTrials.gov Identifier: NCT00831701     History of Changes
Other Study ID Numbers: 1-Hermanns
Study First Received: November 19, 2008
Results First Received: January 11, 2010
Last Updated: May 19, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
Adrenergic alpha antagonists
drug therapy
tamsulosin
ureter

Additional relevant MeSH terms:
Calculi
Ureteral Calculi
Ureterolithiasis
Pathological Conditions, Anatomical
Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Adrenergic alpha-Antagonists
Tamsulosin
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic alpha-1 Receptor Antagonists
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014