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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00489112
Enrollment
Unknown
Registered
2007-06-21
Start date
Unknown
Completion date
Unknown
Last updated
2007-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Ureterolithiasis

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.

Interventions

DRUGAlfuzocine XL 10 mg once a day

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Countries

Israel

Contacts

Primary ContactDORON PEREZ, M.D.
perez_do@clalit.org.il+972-4-6495115

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026