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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04545931
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
9
Anticipated Duration (Months)
8.9
Patients Per Site Per Month

Study Details

Study Description

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-GoĊ‚abek 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Posterior tibial nerve stimulation
  • Drug: Desmopressin Acetate
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
patient will be allocated to either arms of the study using concealed random allocation method.
Primary Purpose:
Treatment
Official Title:
Posterior Tibial Nerve Stimulation Vs Desmopressin In Children With Primary Monosymptomatic Nocturnal Enuresis
Actual Study Start Date :
Mar 15, 2020
Anticipated Primary Completion Date :
Nov 15, 2020
Anticipated Study Completion Date :
Dec 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Posterior tibial nerve stimulation

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

Device: Posterior tibial nerve stimulation
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
Other Names:
  • Urgent PC

    		•
    Experimental: Desmopressin

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

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abo ElRish children hospital Cairo Egypt 11865

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Director: Hany A Morsi, Professor, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahmoud S Amar, MD, Doctor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04545931
    Other Study ID Numbers:
    • M5_64_2020
    First Posted:
    Sep 11, 2020
    Last Update Posted:
    Sep 11, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Mahmoud S Amar, MD, Doctor, Cairo University
    Nocturnal enuresis, PTNS, effect
    Additional relevant MeSH terms:
    Enuresis
    Urinary Incontinence
    Nocturnal Enuresis
    Deamino Arginine Vasopressin

    Study Results

    No Results Posted as of Sep 11, 2020