Clinical trial NCT04545931: Posterior Tibial Nerve Stimulation Vs Desmopressin In Children With Primary Monosymptomatic Nocturnal Enuresis
Official title: Posterior Tibial Nerve Stimulation Vs Desmopressin In Children With Primary Monosymptomatic Nocturnal Enuresis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Primary Monosymptomatic Nocturnal Enuresis
Keywords: Nocturnal enuresis, PTNS, effect
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Nocturnal enuresis is a worldwide health problem frequently encountered in childhood. 85% of cases of nocturnal enuresis are primary mono-symptomatic nocturnal enuresis that can cause substantial psychological impact on children and their families. The currently recommended treatment for NE are not effective in all children with high relapse rate. Posterior tibial nerve stimulation was introduced with early promising results as neuro-modulative therapy for both bladder and bowel dysfunction, although it's mechanism of action is not fully understood.

This study aims to assess the efficacy and role of posterior tibial nerve stimulation versus Desmopressin in primary mono-symptomatic nocturnal enuresis.

80 patients with PMNE were included, over a period of 6 months, at Urology department of Abou ElRish Children's Hospitals, Cairo University. The patients were divided into 2 groups, first group underwent posterior tibial nerve stimulation ( one session per week for 12 weeks ) and the other group of patients received medical treatment (Desmopressin 0.2 mg, single evening dose) for 12 weeks. Both groups are constructed to be adherent to behavioral therapy. The two groups were statistically evaluated regarding the frequency of nocturnal enuresis before, after treatment, and after one month of follow up.

A statistical significant improvement in frequency of NE in both groups being more in group A but there is no statistically significant difference was detected between the two groups. A significant relapse rate after one month of follow in both groups but there is no statistically significant difference was detected between the two groups. Also, there was a statistical significant difference regarding improvement of frequency of NE more with patients with positive surgical history of tonsillectomy in both groups.

This study concluded that both Posterior tibial nerve stimulation and Desmopressin are viable treatment options in patients with primary mono-symptomatic nocturnal enuresis. PTNS is a good option if Desmopressin is contraindicated, fear of it's side effects or ineffective. We should tailor the treatment according to the child and caregiver's condition. Relapse in some responders in both groups with time suggests the need for maintenance therapy.

Eligibility criteria: 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

Primary outcomes:
measure: Posterior tibial nerve stimulation Vs desmopressin In children with primary monosymptomatic Nocturnal enuresis
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Abo ElRish children hospital
Study officials:
affiliation: Cairo University
name: Hany A Morsi, Professor
role: STUDY_DIRECTOR
References: