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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00409227
First received: December 7, 2006
Last updated: June 17, 2008
Last verified: June 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on July 20, 2014