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PLUTO trial protocol: percutaneous shunting for lower urinary tract obstruction randomised controlled trial.

, Mark Kilby, Khalid Khan

    BJOG : an International Journal of Obstetrics and Gynaecology
    |June 15, 2007
    PubMed
    Summary

    This study investigated intrauterine vesicoamniotic shunting for fetal bladder outflow obstruction. Shunting may improve prenatal mortality and renal function in male fetuses with isolated lower urinary tract obstruction.

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    Area of Science:

    • Fetal Medicine
    • Pediatric Nephrology
    • Urology

    Background:

    • Fetal bladder outflow obstruction can lead to severe renal damage and mortality.
    • Intrauterine intervention is being explored as a treatment option.

    Purpose of the Study:

    • To compare intrauterine vesicoamniotic shunting with conservative care for fetal bladder outflow obstruction.
    • To assess improvements in prenatal/perinatal mortality and renal function.
    • To evaluate perinatal morbidity, prognostic factors, and long-term safety and efficacy of shunting.

    Main Methods:

    • Multicentre randomized controlled trial (RCT) in fetal medicine units.
    • Inclusion of pregnant women with singleton male fetuses diagnosed with isolated lower urinary tract obstruction (LUTO).
    • Randomization to vesicoamniotic shunting or expectant management, with follow-up assessing renal function and mortality.

    Main Results:

    • Primary outcomes include perinatal mortality rates and renal function at 4-6 weeks and 12 months.
    • Secondary outcomes assess perinatal morbidity and long-term renal function (serum creatinine, ultrasound, dialysis/transplant need).
    • Prognostic assessment and risk index derivation are secondary objectives.

    Conclusions:

    • The study aims to determine the efficacy and safety of intrauterine shunting for LUTO.
    • Findings will inform clinical management of fetal bladder outflow obstruction.
    • Long-term renal function and survival data are crucial for decision-making.