Efficacy of magnetic stimulation in patients with urinary incontinence after radical prostatectomy: a prospective, randomized, SHAM-controlled clinical trial

Objective: To evaluate the efficacy of magnetic stimulation (MStim) in patients with urinary incontinence (UI) after radical prostatectomy (RP). Method: The study's power was determined to be 85% (Beta=20 and alpha=0.05), requiring a minimum sample size of 18 cases for each group, but considering potential withdrawals (approximately 10% of the total number of patients), a total of 40 men (20 cases in each group) were included in the study. The 40 male patients with post-RP UI who met the inclusion and exclusion criteria were randomly divided into two groups using a table of random numbers. The first group received active MStim (n=20), while the second group received sham MStim (n=20) utilizing an armchair-type MStim device (Novamag NT60). The treatment was administered twice a week for 20 minutes a day, totaling 16 sessions over an 8-week period. In the sham treatment, a thin deflector lead plate was placed on the coil of the magnetic armchair to prevent the magnetic current from penetrating the patient. Patients were assessed for pre-treatment and post-treatment incontinence severity using a 24-hour pad test, a 3-day urination record (including frequency of urination, number of incontinence episodes, nocturia, and pad count), quality of life (IIQ-7), anxiety and depression levels (HAD), level of sexual functioning (IIEF), treatment success (continence rate), cure and recovery rates, and satisfaction with the treatment using a Likert scale. Results: Both groups demonstrated significant improvements in terms of incontinence severity, frequency of urination, number of incontinence episodes, nocturia, and pad count at the end of the treatment compared to pre-treatment (p<0.05). Furthermore, the active MStim group exhibited a statistically significant enhancement in quality of life, anxiety level, total score of sexual functioning, and orgasmic function score at the end of the treatment compared to pre-treatment (p<0.05). At the conclusion of the treatment, the active MStim group showed a statistically significant improvement in terms of incontinence severity, number of incontinence episodes, nocturia, quality of life, anxiety level, total score of sexual functioning, and orgasmic function score compared to the sham MStim group (p<0.05). The active MStim group also demonstrated significantly higher rates of treatment success, cure, recovery, and treatment satisfaction compared to the sham MStim group (p<0.05). No statistically significant differences were observed between the two groups in terms of frequency of urination, pad count, depression level, and other subgroup scores of sexual functioning (p>0.05). Conclusion: Active MStim treatment in patients with post-RP UI demonstrated superiority over sham MStim treatment in terms of clinical parameters associated with incontinence, quality of life, anxiety, and sexual functioning. Keywords: Radical prostatectomy, urinary incontinence, magnetic stimulation