Trial reportNeurourology and urodynamics2026
Rethinking Catheters to Reduce Costs in Urodynamic Evaluation: Do All Roads Lead to Rome?
Trial report in Neurourology and urodynamics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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4 authors.
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Abstract
objectiveTo evaluate the feasibility, safety, and cost-effectiveness of manually manufactured rectal balloon catheters for urodynamic testing as a potential alternative to conventional pre-fabricated devices.
methodsAfter institutional ethics approval, 84 patients scheduled for urodynamic evaluation due to storage and/or voiding lower urinary tract symptoms were prospectively randomized to undergo testing with two different models of handmade rectal balloon catheters. Devices were constructed using the finger portion of non-sterile latex gloves fixed to a 12 Fr urethral catheter with either an elastic band or adhesive tape. Integrity was confirmed by pre-test inflation and leak assessment. All patients underwent standard urodynamic studies (uroflowmetry, cystometry, pressure-flow analysis) performed by an experienced urologist, and outcomes were compared with the historical performance of standard commercial catheters.
resultsNo balloon rupture, leakage, displacement, or material retention was observed in any of the 84 patients. Both models provided reliable intra-abdominal pressure recordings with no interference in urodynamic tracings and no additional discomfort compared with conventional devices. The mean cost per handmade catheter was reduced by over 95% compared with international pre-fabricated catheters and by approximately 94% compared with national products. Projected annual savings exceeded US$3.000 in centers performing 5 urodynamic studies per week. No adverse events or infectious complications were detected.
conclusionsLow-cost handmade rectal balloon catheters demonstrated safe and effective performance in routine urodynamic practice, with significant cost savings. Our findings support the use of handmade catheters as a cost-effective alternative, potentially scalable to public health systems worldwide, particularly in resource-limited settings.
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