May 03, 2017
The Journal of Urology
TAKE-HOME MESSAGE
- This randomized sham-controlled study evaluated response to pulsed magnetic stimulation administered twice weekly for 16 weeks with an option to continue treatment regardless of treatment assignment. Investigators found that women randomized to the active arm were more likely to report a significant improvement in urinary incontinence, defined as a 5-point or greater reduction in the ICIQ-UI SF score. Furthermore, investigators identified a dose–response relationship between treatment intensity and likelihood of response, with 75% of individuals receiving the maximum permitted treatment achieving response.
- Taken together, these data suggest that pulsed magnetic stimulation may be a reasonable nonsurgical management strategy for women with bothersome stress urinary incontinence.
Abstract
PURPOSE
Despite significant differences in success rates between surgical and nonsurgical treatments for female stress urinary incontinence, a few cross-sectional surveys showed that most patients still prefer the latter. We evaluated the efficacy of the under studied nonsurgical treatment using pulsed magnetic stimulation for female stress urinary incontinence.
MATERIALS AND METHODS
This randomized, double-blind, sham controlled study was performed in 120 female subjects at least 21 years old with stress urinary incontinence. Treatment involved pulsed magnetic stimulation for 2 sessions per week for 2 months (16 sessions). After 2 months, subjects could opt for 16 additional sessions regardless of initial randomization. The primary response criterion was a 5-point reduction in the ICIQ-UI SF (International Consultation on Incontinence Questionnaire for Urinary Incontinence-Short Form) score. Key secondary response criteria included objective and subjective cure, supplemented by other secondary criteria. Followups were performed at months 1, 2, 5, 8 and 14.
RESULTS
At 2 months 45 of 60 subjects (75%) in the active arm vs 13 of 60 (21.7%) in the sham arm were treatment responders (p <0.001). After 2 months 24 subjects (40%) in the active arm and 41 (68%) in the sham arm elected additional active pulsed magnetic stimulation. At 14 months, subjects who received 32 sessions of active pulsed magnetic stimulation had the highest percentage of treatment responders (18 of 24 or 75.0%), followed by those who received 16 sessions (26 of 36 or 72.2% and 28 of 41 or 68.3%) and those who did not receive any active pulsed magnetic stimulation (4 of 19 or 21.1%) (p <0.001).
CONCLUSIONS
The encouraging long-term response rates show that pulsed magnetic stimulation is an attractive nonsurgical alternative for patients who do not want to undergo surgery.
Adult women with stress urinary incontinence welcome highly effective, nonsurgical treatment options. Lim et al have described the results of a registered randomized trial of pulsed magnetic stimulation with a primary outcome at 2 months; additional longer-term assessments up to 14 months were also described. In the design of this study, the investigators chose to apply the stimulation in one of two ways—one with the intended therapeutic purpose and one intended to be a sham. The investigators assessed this effort at blinding (masking treatment assignment group); their efforts appear to have been effective, with 66% of sham participants and 46% of actively treated participants reporting that they had received the active treatment. At 2 months, a much higher proportion of properly treated patients experienced symptom score reduction, suggesting that this treatment has efficacy in this clinical population.
Pulsed magnetic stimulation, as delivered in this study, required two sessions per week for 2 months (and a significant percent of participants continued treatments beyond this time). A common concern for both patients and providers is the lack of adherence with recommended pelvic floor physical therapy, a treatment known to have efficacy for mild to moderate stress urinary incontinence. Comparative studies of adherence with these two nonsurgical therapies may provide insight into patient-specific preferences that optimize outcomes. Based on these initial promising results, further studies are needed to replicate and advance this work. With an expanded understanding of this treatment option, providers will be able to appropriately counsel patients based on individual, personalized goals and preferences for treatment of stress urinary incontinence.