Does Treatment With Alfuzosin Increase Success Rates of (SWL) Shock Wave Lithotripsy - Full Text View

Sponsored by:	Assaf-Harofeh Medical Center
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00409227

Purpose

In latest literature more evidence is available about the positive effect of alpha blocker on stone expulsion from the ureter. Patients benefit from less pain and shortening time to stone expulsion. Our study is design to evaluate whether alfuzosin improves the stone free out come following SWL.

Condition	Intervention	Phase
Urolithiasis Nephrolithiasis Ureterolithiasis	Drug: Alpha blocker-alfuzosin Drug: placebo	Phase II

MedlinePlus related topics: Kidney Stones

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective Randomized Placebo Controlled Blinded Study to Evaluate the Efficacy of Alfuzosin (Alpha Blocker) on the Success Rates Following SWL.

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:

use of pain control medication stone free rates [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
pain visual analogue scale [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
side effects [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
stone free rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
time to stone free status [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
need for secondary procedures [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
auxiliary procedures [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	December 2006
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator double blind placebo control	Drug: Alpha blocker-alfuzosin P.O. alfuzosin 10 mg once a day
2: Placebo Comparator placebo control blinded arm	Drug: placebo placebo once a day for 3 months or stone free

Detailed Description:

All patients undergoing SWL are included in study. Exclusion criteria: Patient with radio-lucent stone, patients treated with calcium channel blockers, alpha blockers, steroids, patients with contraindication to alpha blocker treatment, postural hypotension patents with abnormal liver function tests.

Patient will be recruited to the study prospectively. Following signature on inform consent patients will be randomized into 2 groups. One group will be treated with alfuzosin 10mg a day and the control group with placebo. Treatment will be initiated following the lithotripsy treatment.

Parameters for investigation includes: demographic and personal data, stone size and location (obtained by CT or KUB), pain control medication and visual analogue scale assessment of pain, side effects, clinical squeals, stone free out come. Follow up evaluation will be at 1 week, 1 month, and 3 months post treatment. Success will be defined following CT evaluation at 3 months. Treatment ends at stone free achievement or at 3 months.

Endpoints:Stone free rate, time to stone free, side effect.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

patients undergoing shock wave lithotripsy treatment for urolithiasis.

Exclusion Criteria:

patients with abnormal liver function, postural hypotension, alpha-blocker treatment, sensitivity to alpha-blockers, radio-lucent stone, calcium channel blocker treatment, steroids treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409227

Contacts

Contact: yoram I siegel, MD

972-577-345408

ysiegel@asaf.health.gov.il

Locations

Israel
Endourology unit Urology department Assaf Harofeh MC	Recruiting
Zerifin, Israel, 40700
Contact: yoram i siegel, MD 972-577-345408 ysiegel@asaf.health.gov.il
Principal Investigator: yoram i siegel, MD
Sub-Investigator: yaniv shilo, MD

Sponsors and Collaborators

Assaf-Harofeh Medical Center

Investigators

Principal Investigator:

yoram I siegel, MD

Endourology unit Urology department Assaf harofeh MC.

More Information

No publications provided

Responsible Party:	Assaf Harofeh MC ( Yoram I Siegel MD )
Study ID Numbers:	165/05
Study First Received:	December 7, 2006
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00409227 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:

swl
lithotripsy
stone disease
urolithiasis
nephrolithiasis

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Neurotransmitter Agents
Adrenergic Agents
Urolithiasis
Ureteral Calculi
Ureteral Diseases
Cardiovascular Agents
Adrenergic alpha-Antagonists

Antihypertensive Agents
Calculi
Ureterolithiasis
Alfuzosin
Shock
Urologic Diseases
Adrenergic Antagonists
Kidney Diseases
Nephrolithiasis

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Urinary Calculi
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Urolithiasis
Physiological Effects of Drugs
Ureteral Calculi
Ureteral Diseases
Cardiovascular Agents
Adrenergic alpha-Antagonists

Antihypertensive Agents
Calculi
Pharmacologic Actions
Ureterolithiasis
Alfuzosin
Urologic Diseases
Therapeutic Uses
Adrenergic Antagonists
Kidney Diseases
Nephrolithiasis

ClinicalTrials.gov processed this record on May 07, 2009