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

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ClinicalTrials.gov Identifier: NCT00409227
Recruitment Status : Unknown
Verified June 2008 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : December 8, 2006
Last Update Posted : June 18, 2008
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Urolithiasis Nephrolithiasis Ureterolithiasis Drug: Alpha blocker-alfuzosin Drug: placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Placebo Controlled Blinded Study to Evaluate the Efficacy of Alfuzosin (Alpha Blocker) on the Success Rates Following SWL.
Study Start Date : December 2006
Estimated Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. use of pain control medication stone free rates [ Time Frame: 3 months ]
  2. pain visual analogue scale [ Time Frame: 3 month ]
  3. side effects [ Time Frame: 3 months ]
  4. stone free rate [ Time Frame: 3 months ]
  5. time to stone free status [ Time Frame: 3 months ]
  6. need for secondary procedures [ Time Frame: 3 months ]
  7. auxiliary procedures [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Yoram I Siegel MD, Assaf Harofeh MC
ClinicalTrials.gov Identifier: NCT00409227     History of Changes
Other Study ID Numbers: 165/05
First Posted: December 8, 2006    Key Record Dates
Last Update Posted: June 18, 2008
Last Verified: June 2008

Keywords provided by Assaf-Harofeh Medical Center:
swl
lithotripsy
stone disease
urolithiasis
nephrolithiasis

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