OBJECTIVE: To 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. METHODS: After 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. RESULTS: No 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 US3. 000 in centers performing 5 urodynamic studies per week. No adverse events or infectious complications were detected. CONCLUSIONS: Low-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.
Pereira-Correia et al. (Mon,) studied this question.