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

NCT04545931 | Unknown Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: M5_64_2020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Monosymptomatic Nocturnal Enuresis

Keywords

Nocturnal enuresis, PTNS, effect

Outcome Measures

Primary Outcomes (1)

• Posterior tibial nerve stimulation Vs desmopressin In children with primary monosymptomatic Nocturnal enuresis

  Comparative study to show the effect of posterior tibial nerve stimulation

  4 months

Study Arms (2)

Posterior tibial nerve stimulation

EXPERIMENTAL

First arm will undergo posterior tibial nerve stimulation ( one session per week for 12 weeks )

Device: Posterior tibial nerve stimulation

Desmopressin

EXPERIMENTAL

Second arm will receive medical treatment (desmopressin 0.2 mg . single evening dose ) for 12 weeks

Drug: Desmopressin Acetate

Interventions

Posterior tibial nerve stimulation DEVICE

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

Also known as: Urgent PC

Posterior tibial nerve stimulation

Desmopressin Acetate DRUG

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

Desmopressin

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Diurnal enuresis .
• Faecal soiling .
• Cardiovascular disease .
• Renal disorder .
• Neurological disorders .
• Urinary tract infection

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Abo ElRish children hospital

Cairo, 11865, Egypt

RECRUITING

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Hany A Morsi, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mahmoud S Amar, Resident

CONTACT

+2001016072715; mahmoudsalahamar199310@yahoo.com

Hesham I Mohamed, Lecturer

CONTACT

+2001005357411; dr_hisham_ibrahim@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: patient will be allocated to either arms of the study using concealed random allocation method.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 11, 2020
• Study Start: March 15, 2020
• Primary Completion: November 15, 2020
• Study Completion: December 15, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

EG (1)