Treatment of Monosymptomatic Nocturnal Enuresis

Nocturnal Enuresis Clinical Trial

Official title:

Effect of Spinal Magnetic Stimulation Versus Posterior Tibial Neuromodulation in Treatment of Monosymptomatic Nocturnal Enuresis: a Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05306639
• Other study ID #: 0305491
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: July 1, 2023

Study information

• Verified date: January 2023
• Source: University of Alexandria
• Contact: Nehad ElShatby
• Phone: 01090840279
• Email: dr.nehad[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

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

Locations

Country	Name	City	State
Egypt	Nehad ElShatby	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of bed wetting	Number of bed wettings/ week	one month
Primary	Visual analogue scale to determine how much the enuresis affected his/her life.	Visual analogue scale from zero to ten (zero indicates no effect, 10 indicates severe bothersome	three months