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

Therapeutic Effect of Sacral Root Stimulation on Nocturnal Enuresis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02328092
Enrollment
41
Registered
2014-12-31
Start date
2013-05-31
Completion date
2014-12-31
Last updated
2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturnal Enuresis

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.

Interventions

DEVICErSMS in treatment of Nocturnal Enuresis

Real rSMS (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 upword. The stimulation was repeated for 10 sessions, 5 sessions per week and 2 days off. Sham rSMS received stimulation using the same coil, the same session frequency, in the same setting, but the coil was tilted 90.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 20 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the number of bedwetting/week2.5 monthsMeasurment of number of bedwetting/week one month before session, session, after first and second week of stimulation and one month later

Secondary

MeasureTime frameDescription
Quality of life assessment1.5 monthAssessment of Quality of life
VAS1.5 monthMeasurment of VAS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026