Treatment of Monosymptomatic Nocturnal Enuresis

NCT05306639 | Unknown

• 1 other identifier: 0305491
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturnal Enuresis

Keywords

spinal magnetic stimulation, nocturnal enuresis, neuromodulation

Outcome Measures

Primary Outcomes (2)

• Frequency of bed wetting

  Number of bed wettings/ week

  one month

• 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

Study Arms (2)

Spinal magnetic stimulation

EXPERIMENTAL

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

Neuromodulation

EXPERIMENTAL

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

Interventions

Rehabilitation OTHER

rehabilitation sessions using spinal magnetic stimulation or neuromodulation

Neuromodulation; Spinal magnetic stimulation

Eligibility Criteria

• Age: 5 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Nehad ElShatby

Alexandria, 25700, Egypt

Location

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nehad ElShatby

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nehad ElShatby

CONTACT

01090840279; dr.nehad@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: March 13, 2022
• First Posted: April 1, 2022
• Study Start: February 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: three years after publication
• Access Criteria: Researchers can contact the corresponding author directly through e-mail

Locations

EG (1)