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

Phase 4

• Conditions: Primary Monosymptomatic Nocturnal Enuresis
• Interventions: Device: Posterior tibial nerve stimulation; Drug: Desmopressin Acetate

• Registration Number: NCT04545931
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2020-03-15
• Status Verified: 2020-09
• Study First Submitted: 2020-09-06
• Study First Submitted QC: 2020-09-06
• Last Update Submitted: 2020-09-06
• Study First Posted: 2020-09-11
• Last Update Posted: 2020-09-11
• Primary Completion: 2020-11-15
• Study Completion: 2020-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Abo ElRish children hospital; 🇪🇬 Cairo, Egypt