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The Use of Medical-Expulsive Therapy With Alfuzocine xl 10mg x1/d for Distal Ureterolithiasis.a Randomized Prospective Study

Sponsor
HaEmek Medical Center, Israel (Other)
Overall Status
Unknown status
CT.gov ID
NCT00489112
Collaborator
(none)
2
Locations

Study Details

Study Description

Brief Summary

We will performe a prospective randomized study to evaluate the effects of the addition of alfuzocine xl 10 mg once a day for the conservative treatment of selected ureteral stones. A total of 60 patients with distal ureteral calculi will randomly divide into two treatment groups: group A (n=30) who will receive only analgetic therapy(Dipyrone)and diclofenac i.m. 75mg and group B (n=30) who will receive the same therapy plus alfuzocin xl (10 mg/daily) for a maximum of 2 weeks.No significant differences will be between the groups for age, gender distribution and mean stone size measured in the single largest dimension at presentation.Randomization will be done only with the patients permission after they had read a summary describing the goals of conservative management and a description of the drugs they would be taking. Potential side effects and complications of the drugs were discussed. The expulsion rate will the primary end-point of this study.

Condition or Disease Intervention/Treatment Phase
  • Drug: Alfuzocine XL 10 mg once a day
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Stone in the distal ureter until 1 cm of diameter
    Exclusion Criteria:

    • Evidence of urinary tract infection or sepsis

    • Moderate or severe hydronephrosis

    • Acute renal failure

    • Ureteral stricture

    • Stone with >1cm of diameter

    • Previuos use of alpha blocker

    • Pregnancy

    • Previuos ureteral endoscopic or open surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Haemek medical center,urology department Afula Israel 18100
    2 Haemek Medical Center Afula Israel 18100

    Sponsors and Collaborators

    • HaEmek Medical Center, Israel

    Investigators

    • Principal Investigator: doron perez, M.D., HaEmek MC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00489112
    Other Study ID Numbers:
    • 0044-07-EMC
    First Posted:
    Jun 21, 2007
    Last Update Posted:
    Jun 26, 2007
    Last Verified:
    Jun 1, 2007
    Additional relevant MeSH terms:
    Ureterolithiasis
    Ureteral Calculi

    Study Results

    No Results Posted as of Jun 26, 2007