A Double-blind Randomized Clinical Trial on the Efficacy of Magnetic Sacral Roots Stimulation for the Treatment of NE

Not Applicable

Completed

• Conditions: Nocturnal Enuresis
• Interventions: Device: rSMS in treatment of Nocturnal Enuresis

• Registration Number: NCT02328092
• Lead Sponsor: Assiut University

Brief Summary

The purpose of this study is to assess the efficacy of daily sacral root magnetic stimulation for 10 sessions in patients with nocturnal enuresis.Eligible patients were randomized to receive either real or sham 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. Cortical excitability of upper and lower limbs were done before and after the end of sessions.

Detailed Description

The purpose of this study is to assess the efficacy of daily sacral root magnetic stimulation for 10 sessions in patients with nocturnal enuresis. Eligible patients were randomized to receive either real or sham 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. Cortical excitability of upper and lower limbs were done before and after the end of sessions.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2014-12-26
• Study First Posted: 2014-12-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-12
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• All subjects diagnosed as patients with primary monosymptomatic nocturnal enuresis according to the Diagnostic and statistical manual of mental disorders, 4th revised edn (DSM-IV)

Exclusion Criteria

• We exclude any patient with pacemakers or any metallic devices
• Patients with evidence of urinary tract infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Group	rSMS in treatment of Nocturnal Enuresis	The control group received sham rSMS stimulation using the same coil, the same session frequency, in the same setting, but the coil was tilted 90.
Real group	rSMS in treatment of Nocturnal Enuresis	The real group received biphasic rSMS using a Magstim Super Rapid (Magstim, Whitland, UK) stimulator connected to a 120-mm outer diameter figure-of-8 air film cooling coil positioned in the midline over the sacral vertebrae (approximately 5 cm above the natal cleft, which approximates to the level of S2). Stimulation was delivered at 15 Hz at 50% of maximum stimulator output (10 seconds on and 30 seconds off) with a total of 1500 pulses and the hand of the coil upward. The stimulation was repeated for 10 sessions, 5 sessions per week and 2 days off.

Primary Outcome Measures

Name	Time	Method
the number of bedwetting/week	2.5 months	Measurment of number of bedwetting/week one month before session, session, after first and second week of stimulation and one month later

Secondary Outcome Measures

Name	Time	Method
VAS	1.5 month	Measurment of VAS
Quality of life assessment	1.5 month	Assessment of Quality of life