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Does Treatment With Alfuzosin Increase Success Rates of (SWL) Shock Wave Lithotripsy

NCT ID: NCT00409227

Last Updated: 2008-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urolithiasis Nephrolithiasis Ureterolithiasis

Keywords

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swl lithotripsy stone disease urolithiasis nephrolithiasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

double blind placebo control

Group Type ACTIVE_COMPARATOR

Alpha blocker-alfuzosin

Intervention Type DRUG

P.O. alfuzosin 10 mg once a day

2

placebo control blinded arm

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo once a day for 3 months or stone free

Interventions

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Alpha blocker-alfuzosin

P.O. alfuzosin 10 mg once a day

Intervention Type DRUG

placebo

placebo once a day for 3 months or stone free

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Assaf Harofeh MC

Principal Investigators

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yoram I siegel, MD

Role: PRINCIPAL_INVESTIGATOR

Endourology unit Urology department Assaf harofeh MC.

Locations

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Endourology unit Urology department Assaf Harofeh MC

Ẕerifin, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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yoram I siegel, MD

Role: CONTACT

Phone: 972-577-345408

Email: [email protected]

Facility Contacts

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yoram i siegel, MD

Role: primary

Other Identifiers

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165/05

Identifier Type: -

Identifier Source: org_study_id