Treatment of Monosymptomatic Nocturnal Enuresis

• Sponsor: University of Alexandria (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05306639
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3
• Patients Per Site Per Month: 13.4

Study Details

Study Description

Brief Summary

A prospective randomized trial to study the effect of spinal magnetic stimulation versus posterior tibial neuromodulation in the treatment of monosymptomatic nocturnal enuresis.

Condition or Disease	Intervention/Treatment	Phase
Nocturnal Enuresis	Other: Rehabilitation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Spinal Magnetic Stimulation Versus Posterior Tibial Neuromodulation in Treatment of Monosymptomatic Nocturnal Enuresis: a Prospective Randomized Clinical Trial
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

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	Other: Rehabilitation; rehabilitation sessions using spinal magnetic stimulation or neuromodulation
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	Other: Rehabilitation; rehabilitation sessions using spinal magnetic stimulation or neuromodulation

Outcome Measures

Primary Outcome Measures

1. Frequency of bed wetting [one month]

   Number of bed wettings/ week

2. Visual analogue scale to determine how much the enuresis affected his/her life. [three months]

   Visual analogue scale from zero to ten (zero indicates no effect, 10 indicates severe bothersome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nehad ElShatby	Alexandria		Egypt	25700

Sponsors and Collaborators

• University of Alexandria

Investigators

• Principal Investigator: Nehad ElShatby, Alexandria University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nehad Mohamed Elshatby Mahmoud, Physician, University of Alexandria
• ClinicalTrials.gov Identifier: NCT05306639
• Other Study ID Numbers: 0305491
• First Posted: Apr 1, 2022
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nehad Mohamed Elshatby Mahmoud, Physician, University of Alexandria: spinal magnetic stimulation, nocturnal enuresis, neuromodulation
• Additional relevant MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis

Study Results

No Results Posted as of Apr 1, 2022