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

June 17, 2008 updated by: Assaf-Harofeh Medical Center

Prospective Randomized Placebo Controlled Blinded Study to Evaluate the Efficacy of Alfuzosin (Alpha Blocker) on the Success Rates Following SWL.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 40700
        • Recruiting
        • Endourology unit Urology department Assaf Harofeh MC
        • Contact:
        • Principal Investigator:
          • Yoram I Siegel, MD
        • Sub-Investigator:
          • yaniv shilo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
double blind placebo control
Drug: Alpha blocker-alfuzosin
P.O. alfuzosin 10 mg once a day
Placebo Comparator: 2
placebo control blinded arm
Drug: placebo
placebo once a day for 3 months or stone free

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
use of pain control medication stone free rates
Time Frame: 3 months
3 months
pain visual analogue scale
Time Frame: 3 month
3 month
side effects
Time Frame: 3 months
3 months
stone free rate
Time Frame: 3 months
3 months
time to stone free status
Time Frame: 3 months
3 months
need for secondary procedures
Time Frame: 3 months
3 months
auxiliary procedures
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: yoram I siegel, MD, Endourology unit Urology department Assaf harofeh MC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

December 7, 2006

First Submitted That Met QC Criteria

December 7, 2006

First Posted (Estimate)

December 8, 2006

Study Record Updates

Last Update Posted (Estimate)

June 18, 2008

Last Update Submitted That Met QC Criteria

June 17, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 165/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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