Treatment of Monosymptomatic Nocturnal Enuresis

Not Applicable

Not yet recruiting

• Conditions: Nocturnal Enuresis

• Registration Number: NCT05306639
• Lead Sponsor: University of Alexandria

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.

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 Timeline

• Study First Submitted: 2022-03-13
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-04-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12
• Study Start: 2023-02-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Frequency of bed wetting	one month	Number of bed wettings/ week
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

Trial Locations

Locations (1)

Nehad ElShatby; 🇪🇬 Alexandria, Egypt