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

Assiut University

Status: Completed

Conditions: Nocturnal Enuresis

Treatments: Device: rSMS in treatment of Nocturnal Enuresis

Study type: Interventional

Funder types: Other

Identifiers

NCT02328092

rSMS in nocturnal enuresis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 7 to 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups

Real group

Active Comparator group

Description:

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.

Treatment:

Device: rSMS in treatment of Nocturnal Enuresis

Sham Group

Sham Comparator group

Description:

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.

Treatment:

Device: rSMS in treatment of Nocturnal Enuresis