ClinicalTrials.gg
Status unknownNCT05306639Updated Jan 12, 2023

Treatment of Monosymptomatic Nocturnal Enuresis

An interventional study of Rehabilitation in Nocturnal Enuresis, sponsored by University of Alexandria. Status unknown at 1 site in Egypt. Open to participants aged 5 Years to 30 Years. Per ClinicalTrials.gov, last updated 2023-01-12.

Sponsored by University of Alexandria · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Not yet recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
5 Years to 30 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 22 studies in Nocturnal Enuresis with a site in Egypt — 5 open to participants now, 7 under way, 2 of them phase 3. Nocturnal Enuresis · Egypt.

Planned enrollment
18th of 18
40 · median 95
Started
2023
with 2 others
No phase
13 of 22
4 open now
Registered
5th of 22
by date

Among the 22 studies in Nocturnal Enuresis with a site in Egypt, this one is the 18th largest by planned enrollment of the 18 interventional ones that give a count, is one of 3 that started in 2023, is one of 13 with no phase, and was the 5th registered.

Nocturnal Enuresis

105 studies on the registry are indexed under Nocturnal Enuresis; 22 are open to participants now.

Browse Nocturnal Enuresis studies →

Open to participants now

5 of the 22 studies in Nocturnal Enuresis with a site in Egypt are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 14 Nocturnal Enuresis studies recruiting now, 5 (36%) set no upper age limit and 9 (64%) stop at 75 or younger; 8 take children under 18; 2 take healthy volunteers.

This study: 5 Years to 30 Years · all sexes · no healthy volunteers.

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02

Study summary

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

Read the 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

03

Conditions studied

  • Nocturnal Enuresis

Browse trials for

Keywords

  • spinal magnetic stimulation, nocturnal enuresis, neuromodulation
04

Who can participate

Ages eligible
5 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All subjects were diagnosed as patients with MNE according to the , 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

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherRehabilitation

    rehabilitation sessions using spinal magnetic stimulation or neuromodulation

06

What researchers measure

Primary outcomes

  1. Frequency of bed wetting

    Number of bed wettings/ week

    Time frame: one month

  2. 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

    Time frame: three months

07

Study locations

1 site
  • Nehad ElShatby
    Alexandria, 25700, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — All data will be available with the corresponding author to be shared with other researchers for three years after publishing the study

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: three years after publication

Access criteria: Researchers can contact the corresponding author directly through e-mail

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2023; primary completion for Jun 2023, 4 months later.

Of 41 interventional studies with no phase under Nocturnal Enuresis, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's planned 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2022
First posted
Apr 1, 2022
StartEst.
Feb 1, 2023
Primary completionEst.
Jun 1, 2023
CompletionEst.
Jul 1, 2023
Last update
Jan 12, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05306639
Lead sponsor
University of Alexandria
Responsible party
Nehad Mohamed Elshatby Mahmoud (Physician, University of Alexandria) — Principal investigator
First posted
Apr 1, 2022
Start date
Feb 1, 2023 (estimated)
Primary completion
Jun 1, 2023 (estimated)
Completion
Jul 1, 2023 (estimated)
Last update
Jan 12, 2023

Study contacts

Nehad ElShatby
Contact
dr.nehad@yahoo.com
01090840279
Nehad ElShatby
principal investigator · Alexandria University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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