- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05306639
Treatment of Monosymptomatic Nocturnal Enuresis
Effect of Spinal Magnetic Stimulation Versus Posterior Tibial Neuromodulation in Treatment of Monosymptomatic Nocturnal Enuresis: a Prospective Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Nocturnal enuresis is defined as "nighttime bedwetting in children aged five years or older.Currently available treatment options for nocturnal enuresis include medication, wetting alarms, lifestyle changes, sacral magnetic stimulation, and posterior tibial neurmodulation.
Magnetic stimulation is a valid method for stimulation of sacral as functional electrical stimulation. It generates a more powerful and deeper electrical field than that produced by conventional electrical stimulators. So, magnetic stimulation could be considered an attractive form of electrical therapy, being relatively painless, non-invasive and free from side effects.Peripheral neuromodulation is the modulation of the physiologic behavior of the nerve by electrical stimulation. Posterior tibial neuromodulation is an effective method in treatment of urinary incontinence
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nehad ElShatby
- Phone Number: 01090840279
- Email: dr.nehad@yahoo.com
Study Locations
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-
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Alexandria, Egypt, 25700
- Nehad ElShatby
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All subjects were diagnosed as patients with MNE according to the Diagnostic and statistical manual of mental disorders, 4th revised edition (DSM-IV) (American Psychiatric Association's DSM-IV, 1994): bed-wetting ≥3 times a week; lasting more than 6 months; can control urination during the day but cannot control urination after falling asleep.
Exclusion Criteria:
- - Patients younger than 5 years old.
- Patients who have any abnormality in blood or urine biochemistry.
- Patients with other urinary symptoms.
- Patients with neurological or endocrinal abnormalities (such as cerebral palsy, spinal cord lesion, peripheral neuropathy or diabetes mellitus)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Spinal magnetic stimulation
Spinal magnetic stimulation group will receive repetitive spinal magnetic stimulation sessions for a total of 12 sessions.
Using the Neuro-MS/D machine, circular coil will be used to stimulate S2,3 and 4 sacral roots.
The outer rim of the coil will be positioned in the midline over the sacral vertebrae (approximately 5 cm above the natal cleft, which approximates to the level of S2) Intensities will be adjusted to 50-70 % of maximal output (2.2 Tesla), stimulation frequency will be fixed at 15 Hz, burst length = 10 seconds, inter-burst interval = 30 seconds with a total of 1500 pulses
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rehabilitation sessions using spinal magnetic stimulation or neuromodulation
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Experimental: Neuromodulation
Neuromodulation group will receive 12 sessions of bilateral transcutaneous posterior tibial neuromodulation using (Myomed 632®, Enraf Nonius, Delft, Netherlands) machine, the active rubber surface was placed behind the medial malleolus and the reference electrode was placed 10 cm proximal.
Adjustment of the electric current was as follows: continuous current, pulse duration 200 ms, frequency 20 Hz; each session lasts for 30 min.
The current intensity was adjusted according to the tolerance of the patient or until the big toe curls into plantar flexion
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rehabilitation sessions using spinal magnetic stimulation or neuromodulation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of bed wetting
Time Frame: one month
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Number of bed wettings/ week
|
one month
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Visual analogue scale to determine how much the enuresis affected his/her life.
Time Frame: three months
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Visual analogue scale from zero to ten (zero indicates no effect, 10 indicates severe bothersome
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three months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nehad ElShatby, Alexandria University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0305491
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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