Therapy with Nerve Electrical Stimulation associated with the drug Desmopressin for the treatment of children who wet the bed during their sleep

Not Applicable

• Conditions: D053206; Monosymptomatic Enuresis

• Registration Number: RBR-4dcjfr7
• Lead Sponsor: niversidade Federal de Minas Gerais

Brief Summary

Introduction: Enuresis is defined as urinary incontinence during sleep that occurs after 5 years of age. The most common form of this condition is monosymptomatic enuresis, in which daytime urinary symptoms do not coexist. Treatment with desmopressin is established, but there is no complete response to symptoms. Transcutaneous parasacral nerve electrical stimulation is well established in the treatment of lower urinary tract disorders, and has recently shown good results in monosymptomatic enuresis. The association of different treatment modalities has been studied, but there is no study evaluating the association of these two modalities. Objective: To evaluate the clinical response of transcutaneous parasacral nerve electrical stimulation associated with desmopressin in children with monosymptomatic enuresis compared to treatment with desmopressin. Material and methods: Prospective, controlled and randomized study, where the children involved will be divided into two groups: CG (desmopressin and placebo electrical stimulation) and GI (desmopressin and electrical stimulation). Both groups will perform 16 electrotherapy sessions, once a week, for 40 minutes, with the following parameters: frequency of 10 Hz, pulse width of 700 µs and intensity determined by the patient. Improvement in enuresis will be assessed using the dry nights calendar and will be performed at two times, 4 months and 6 months after the end of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-18
• Last Update Posted: 29 May 2023
• Study Completion: 2023-07-11
• Results First Posted: 2023-07-24

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Children and adolescents aged 6 to 11 years, 11 months and 29 days with a diagnosis of primary NME; not receiving any enuresis treatment modality in the last 2 months; children and adolescents whose parents or guardians agreed to participate in the study, after reading, understanding and signing the Informed Consent Form (FICF) and Informed Consent Form.

Exclusion Criteria

Use of medication that changes the action of the detrusor muscle or external urethral sphincter; use of pacemaker; presence of polydipsia of any etiology;presence of moderate to severe intellectual disability of any nature identified by Raven's Progressive Matrices Test; families who refuse to attend the research clinic once a week
- Children and adolescents diagnosed with primary NME and whose parents or guardians did not accept to participate in the study and/or did not sign an Informed Consent Form (FICF) and an Assent Term
- Non-monosymptomatic or secondary enuresis

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in the number of dry nights, that is, nights without episodes of enuresis; evaluated by the calendar of dry nights; the result parameters are:<br>No response = reduction in number of enuretic episodes <50%<br>Partial response = 50% to 99% reduction in the number of enuretic episodes.<br>Complete answer = no enuresis.<br>This result will be verified immediately after the completion of the protocol (16th session)<br>

Secondary Outcome Measures

Name	Time	Method
Defined by the number of dry nights, ie nights without episodes of enuresis, verified in the dry nights calendar after 6 months of completion of the treatment protocol. The result parameters are:<br>No response = reduction in number of enuretic episodes <50%<br>Partial response = 50% to 99% reduction in the number of enuretic episodes.<br>Complete answer = no enuresis