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NCT04545931: PTNS

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

Status unknown Phase 4 Last updated 11 September 2020
What this trial tests

Phase 4 trial testing Posterior tibial nerve stimulation in Primary Monosymptomatic Nocturnal Enuresis in 80 participants. Status unknown.

Timeline
15 March 2020
Primary endpoint
15 November 2020
15 December 2020

Quick facts

Lead sponsorCairo University
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment80
Start date15 March 2020
Primary completion15 November 2020
Estimated completion15 December 2020
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Cairo University

Who can join

Adults 5 to 12, any sex, with Primary Monosymptomatic Nocturnal Enuresis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Posterior tibial nerve stimulation versus desmopressin in treating children with primary mono-symptomatic nocturnal enuresis. A randomized clinical trial.
    Abdelghany M, Amar MS, Shoukry AI, Morsi H, et al · · 2024 · cited 1× · PMID 39355791 · DOI 10.1080/20905998.2024.2373404

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