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Comparative Treatment Study in Patients With Lower Ureteral Stones

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00397397
Collaborator
(none)
60
Enrollment
1
Location
1.9
Duration (Months)
31
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We wish to determine the best treatment for expulsion of lower ureteral stones. Which of the three major treatment protocols is the best treatment of conservative management of ureteral stones?

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study will include 60 patients with lower ureteral stones. The patients will be divided into three groups. The first group will be administered Alfuzosin (10 mg). The second group will be administered a combination of Alfuzosin (10 mg)and Rowatinex (Pinene 31%, Camphene 15%, Anetol 4%, Borneol 10%, Cineol 3%, Fenchenol 4%, Olive Oil 33%). The third group will be administered Rowatinex.

    Study Design

    Study Type:
    Observational
    Time Perspective:
    Other
    Official Title:
    Comparative Study in Patients With Lower Ureteral Stones Treated With 10 MG Alfuzosin,10 MG Alfuzosin With Rowatinex, and Rowatinex Alone
    Study Start Date :
    Jan 1, 2007
    Study Completion Date :
    Mar 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Clinical diagnosis of lower ureter (urinary calculi) up to 8mm

      • Must be able to swallow tablets

      Exclusion Criteria:

      • Sensitivity to Alfuzosin and Rowatinex

      • Pregnant and breastfeeding women

      • Single kidney

      • Obstructing stone

      • Renal failure creatinine up to 1.8 mg/dl

      • Patients using various alpha blockers

      • Liver failure

      • Fever higher than 38 C

      • UTI

      • Syncope or hypotension

      • Patients treated with PDE5

      • Patients treated with inhibitor CYP3A4

      • Patients refusing participation

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Hillel Yaffe Medical Center Hadera Israel 38100

      Sponsors and Collaborators

      • Hillel Yaffe Medical Center

      Investigators

      • Principal Investigator: Gabriel Faragi, Urology Department, Hillel Yaffe Medical Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00397397
      Other Study ID Numbers:
      • 15/2006CTIL
      First Posted:
      Nov 9, 2006
      Last Update Posted:
      Nov 9, 2006
      Last Verified:
      Nov 1, 2006
      Keywords provided by , ,
      Urinary Calculi
      Rowatinex
      Alfuzosin
      Drug Therapy
      Additional relevant MeSH terms:
      Ureteral Calculi
      Ureterolithiasis
      Urinary Calculi
      Urolithiasis
      Calculi

      Study Results

      No Results Posted as of Nov 9, 2006