The clinical application of a novel minimally invasive non-surgical treatment for stress urinary incontinence

Aim:

This study introduces a pioneering approach to managing stress urinary incontinence (SUI) through a novel device that utilizes intravesical gas as a pressure dampener, leveraging the unique property of compressibility as dictated by Boyle’s law ($P$ $\propto$ $1/V$). It aims to assess the device’s efficacy and its impact on the quality of life in women with SUI.

Methods:

Adhering to a protocol approved by SingHealth CIRB (reference 2017/2543), informed consent was secured from 27 patients who met the inclusion and exclusion criteria, of which 22 completed the full study protocol. The study’s primary outcome measures were the differences in 1-h and 24-h pad weight tests, while secondary outcomes included incontinence quality of life (I-QOL) scoring, urodynamics parameter changes and safety data. Outcome measures were analyzed using the Wilcoxon signed-rank test for non-normally distributed data and the paired t-test for normally distributed data, as appropriate.

Results:

The cohort comprised entirely of females, with a mean age of 49.1 years (range 29–65 years). The 1-h pad weight test demonstrated significant improvement, with the mean pad weight decreasing from 4.0 g to 1.41 g ($p$ < 0.05). Similarly, the 24-h pad weight test reflected a reduction from 13.06 g to 7.76 g ($p$ < 0.01). An increase in the mean Valsalva leak point pressure (VLPP) from approximately 90.91 cmH2O before treatment to 125.70 cmH2O post-treatment ($p$ < 0.01) was recorded. Notably, mean I-QOL scores significantly improved from 65.5 to 84.0 ($p$ < 0.01), reflecting enhanced quality of life across various domains. No patients experienced urinary tract infections, serious traumatic events, or required secondary or unplanned surgical interventions.

Conclusion:

The novel intravesical gas-based device demonstrates significant improvements in managing SUI, evidenced by both primary and secondary outcome measures. These findings suggest the device’s potential as a valuable addition to the spectrum of treatment options for SUI, promising enhanced physiological and quality of life benefits for affected women.