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

Desmopressin-associated Transcutaneous Parasacral Nerve Stimulation in Monosymptomatic Enuresis: a blinded, randomized, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4dcjfr7
Enrollment
Unknown
Registered
2022-01-18
Start date
2022-02-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monosymptomatic Enuresis

Interventions

Control group (CG): 50 participants - Urotherapy: these are guidelines on changes in habits such as: reducing water intake 2 hours before bedtime, urinating right before bedtime, avoiding foods rich
D003894
E02331800
D053206

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Universidade Federal de Minas Gerais
Collaborator

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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: No response = reduction in number of enuretic episodes <50% Partial response = 50% to 99% reduction in the number of enuretic episodes. Complete answer = no enuresis. This result will be verified immediately after the completion of the protocol (16th session)

Secondary

MeasureTime frame
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: No response = reduction in number of enuretic episodes <50% Partial response = 50% to 99% reduction in the number of enuretic episodes. Complete answer = no enuresis

Countries

Brazil

Contacts

Public ContactUniversidade Federal de Minas Gerais
mapq@medicinaufmg.br+55(31)34099647

Outcome results

None listed

Source: REBEC (via WHO ICTRP)