Treatment of stress urinary incontinence with a percutaneously implantable wireless microstimulator device (NuStim®) plus pelvic floor muscle exercises: a pilot study.

Objectives: To evaluate the utility and safety of pelvic floor muscle exercises in combination with a wireless percutaneously implantable microstimulator device (NuStim^®) for the treatment of stress urinary incontinence.

Methods: In this prospective self-controlled pilot trial, three patients aged 35-75 years with incontinence symptoms were treated by pelvic floor muscle exercises plus implantation of NuStim^® from June 2017 to March 2019. The patients received 25 weeks of pelvic floor training, during which the patients' incontinence was quantitatively assessed by a 1-h pad test. Self-reported scores were used to rate the effect of treatment in terms of the quality of daily life, with pelvic floor muscle strength evaluated on the modified Oxford scale at each follow-up visit.

Results: All three patients (2 males and 1 female) completed the trial without dropouts. The results showed that their incontinence symptoms were alleviated, as measured by a decrease in the normalized weight of the 1-h pad test, which presented a significant linear trend (P = 0.0021). An intragroup analysis revealed that all participants achieved statistically significant improvement in terms of the 1-h pad test score at 25 weeks as compared with pre-training findings. Nonetheless, no significant difference was found between the results of the other follow-up points and the baseline before treatment (P = 0.058). Comparison of the secondary outcome variable scores in each participant showed no significant difference at the conclusion of the study.

Conclusions: Use of the NuStim^® during pelvic floor muscle exercises resulted in significant improvement in incontinence symptoms. The device was shown to be useful and safe as an adjunct to the pelvic floor training for the treatment of stress urinary incontinence.