Posterior Tibial Nerve Stimulation Vs Desmopressin In Children With Primary Monosymptomatic Nocturnal Enuresis

Short name PTNS

NCTNCT04545931Other idM5_64_2020

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Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 80 participants (estimated)
Sponsor: Cairo University · Other
Design: Randomized · Double masking
Countries: 1 country
Egypt
Start: 15 Mar 2020
Primary completion: 15 Nov 2020 (estimated)
Completion: 15 Dec 2020 (estimated)
First posted: 11 Sept 2020
Last update posted: 11 Sept 2020
Conditions: Primary Monosymptomatic Nocturnal Enuresis

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20202021

Ph 4
PTNS
NCT04545931
15 Mar 2020 to est. 15 Dec 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Nocturnal enuresis is a worldwide health problem frequently encountered in childhood . It affects 18 % of younger school- age children in Egypt. It is the most frequent (85%) type of enuresis in children (Eberdt-Gołabek et al, 2013), . Nocturnal enuresis includes monosymptomatic nocturnal enuresis with no day time urinary symptoms and non monosymptomatic nocturnal enuresis that accompanied by day time urinary symptoms . It can cause severe psychological and social distress to children and their parents . The currently recommended treatment such as alarms , antidiuretic hormone and anticholenergics are not effective in all children with significant relapse rate . Although it's mechanism of action is not fully elucidated , posterior tibial nerve stimulation is safe and acceptable, with evidence of potential clinical effect for both bladder and bowel dysfunction (Bellette et al, 2009). This study will investigate the effect of posterior tibial nerve stimulation on primary monosymptomatic nocturnal enuresis in children.

Interventions

Posterior tibial nerve stimulationDevice
Desmopressin AcetateDrug

Arms2

Experimental
Posterior tibial nerve stimulation
First arm will undergo posterior tibial nerve stimulation ( one session per week for 12 weeks )
Experimental
Desmopressin
Second arm will receive medical treatment (desmopressin 0.2 mg . single evening dose ) for 12 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

Posterior tibial nerve stimulation Vs desmopressin In children with primary monosymptomatic Nocturnal enuresis
Time frame · 4 months
Registry description
Comparative study to show the effect of posterior tibial nerve stimulation

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 5 Years up to 12 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: Aged between 5 and 13 years old . * Experiencing more than two wetting episodes per week . * Normal urinalysis results . * Unremarkable urinary tract ultrasaound . * Normal physical examination. Exclusion Criteria: * Diurnal enuresis . * Faecal soiling . * Cardiovascular disease . * Renal disorder . * Neurological disorders . * Urinary tract infection

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