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

NCT04545931 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-09-11

No results posted yet for this study

Summary

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.

Conditions

  • Primary Monosymptomatic Nocturnal Enuresis

Interventions

DEVICE

Posterior tibial nerve stimulation

34-gauge stainless steel needle is inserted about three finger breadths cephalad to the medial malleolus. In children, previous administration of a topical anesthetic agent (e.g. lidocaine) can help to reduce pain and fear associated with needle insertion. The goal is to place the tip of the needle close to the PTN without actually touching it. The negative electrode is placed on the same leg near the arch of the foot. The needle and the electrode are connected to a low voltage (9 V) stimulator

DRUG

Desmopressin Acetate

0.2 mg, single evening dose ) for 12 weeks, tapering to half of the dose daily for two weeks before discontinuation

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Hany A Morsi, Professor · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-15
Primary Completion
2020-11-15
Completion
2020-12-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04545931 on ClinicalTrials.gov