A double-blind randomized clinical trial on the efficacy of magnetic sacral root stimulation for the treatment of Monosymptomatic Nocturnal Enuresis

Eman M Khedr, Khaled A Elbeh, Ahmed Abdel Baky, Noha Abo-Elfetoh, Dina H El-Hammady, Fatma Korashy, Eman M Khedr, Khaled A Elbeh, Ahmed Abdel Baky, Noha Abo-Elfetoh, Dina H El-Hammady, Fatma Korashy

Abstract

Purpose: Purpose of this study was to evaluate the long term efficacy of repetitive sacral root magnetic stimulation (rSMS) in patients with monosymptomatic nocturnal enuresis (MNE).

Methods: Forty four patients were randomized to receive either sham or real repetitive sacral root magnetic stimulation (rSMS; 15 Hz with a total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting treatment, immediately after the 5th and 10th treatment session, and 1 month later, using frequency of enuresis/week, visual analogue scale (VAS) and quality of life as outcome measures. Resting and active motor thresholds of gastrocnemius muscles were measured before and after the end of sessions.

Results: Both treatment and control groups were comparable for baseline measures of frequency of enuresis, and VAS. The mean number of wet nights/week was significantly reduced in patients who received real rSMS. This improvement was maintained 1 month after the end of treatment. Patients receiving real-rSMS also reported an improvement in VAS ratings and quality of life. A significant reduction of resting motor threshold was recorded after rSMS in the real group while no such changes were observed in the sham group.

Conclusion: These findings suggest that rSMS has potential as an adjuvant treatment for MNE and deserves further study.

Trial registration: ClinicalTrials.gov NCT02328092.

Keywords: Nocturnal enuresis; quality of life; repetitive sacral root magnetic stimulation; targeted electrical or magnetic sacral root stimulation.

Figures

Fig.1
Fig.1
Flow chart of the patients through the course of the study.
Fig.2
Fig.2
Shows changes in the frequency of wet night/week (a), and the changes of the visual analogue scale (b) in patients with monosymptomatic nocturnal enuresis at different points of assessment. The frequency of wet night/week was assessed one month prior to sacral stimulation (first point), first week of stimulation (second point), second week of stimulation (third point and one month after the end of stimulation (fourth point). On VAS scale 3 points of assessment one month before, after the end of stimulation and one month after. Data expressed as mean ± Standard Errors (SE). The significances between groups appeared at different points of assessment in comparison to base line assessment. These were seen mainly in the frequency of wet night/week one month after the end of stimulation and for VAS appeared after the end of stimulation and one month later.
Fig.3
Fig.3
Shows changes in the score of Quality of lie (SF-36v2 Health survey) in patients with monosymptomatic nocturnal enuresis in the two studied groups before and one month after the end of stimulation. There were significant improvement in the score of Mental health domains including Social Functioning (SF), Vitality (VT), Mental Health (MH) and Component Mental Health Summation (CMHS) in real group versus sham group. However there was no significant difference between groups in different component of Physical health. Data expressed as mean ± Standard Errors (SE).
Fig.4
Fig.4
Shows changes in the resting and active motor threshold pre-post-sessions in patients with monosymptomatic nocturnal enuresis in the two studied groups. There was a significant decrease in resting motor threshold after session in real group in comparison to sham group, while no such change was recorded in active motor threshold. Data expressed as mean ± Standard Errors (SE).

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