Medical Expulsive Therapy of Single Distal Ureteral Stones - Full Text View

Sponsored by:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00831701

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

Drug Information available for: Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Medical Expulsive Therapy of Single Distal Ureteral Stones. A Randomised, Double-Blind and Placebo-Controlled Study

Further study details as provided by University of Zurich:

Primary Outcome Measures:

expulsion rate [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time top stone passage [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
required analgesics [ Time Frame: until stone expulsion ] [ Designated as safety issue: Yes ]
maximum pain score per day [ Time Frame: until stone expulsion ] [ Designated as safety issue: Yes ]
maximum daily pain score [ Time Frame: until stone expulsion ] [ Designated as safety issue: Yes ]
intervention rate [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

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
1: Active Comparator Tamsulosin	Drug: Tamsulosin 0.4 mg Tamsulosin once daily for 21 days
2: Placebo Comparator Placebo	Drug: Placebo

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

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

Responsible Party:	Department of Urology, University Hospital Zürich, switzerland ( Räto T. Strebel )
Study ID Numbers:	1-Hermanns
Study First Received:	November 19, 2008
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00831701 History of Changes
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University of Zurich:

Adrenergic alpha antagonists
drug therapy
tamsulosin
ureter

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Neurotransmitter Agents
Adrenergic Agents
Urolithiasis
Ureteral Calculi
Ureteral Diseases

Adrenergic alpha-Antagonists
Calculi
Ureterolithiasis
Urologic Diseases
Tamsulosin
Adrenergic Antagonists

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Urinary Calculi
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Antineoplastic Agents
Urolithiasis
Physiological Effects of Drugs
Ureteral Calculi

Ureteral Diseases
Adrenergic alpha-Antagonists
Calculi
Pharmacologic Actions
Ureterolithiasis
Urologic Diseases
Therapeutic Uses
Tamsulosin
Adrenergic Antagonists

ClinicalTrials.gov processed this record on May 06, 2009