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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328092
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Eman M. Khedr, 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.

Condition or disease Intervention/treatment Phase
Nocturnal Enuresis Device: rSMS in treatment of Nocturnal Enuresis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Sacral Root Stimulation on Nocturnal Enuresis
Study Start Date : May 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Real group
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.
Device: rSMS 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.

Sham Comparator: Sham Group
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.
Device: rSMS 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.




Primary Outcome Measures :
  1. the number of bedwetting/week [ Time Frame: 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 :
  1. Quality of life assessment [ Time Frame: 1.5 month ]
    Assessment of Quality of life

  2. VAS [ Time Frame: 1.5 month ]
    Measurment of VAS



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eman M. Khedr, Clinical professor, Assiut University
ClinicalTrials.gov Identifier: NCT02328092    
Other Study ID Numbers: rSMS in nocturnal enuresis
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Enuresis
Urinary Incontinence
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations