Posterior Tibial Nerve Stimulation Vs Desmopressin In Children With Primary Monosymptomatic Nocturnal Enuresis (PTNS)
Primary Purpose
Primary Monosymptomatic Nocturnal Enuresis
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Posterior tibial nerve stimulation
Desmopressin Acetate
Sponsored by
About this trial
This is an interventional treatment trial for Primary Monosymptomatic Nocturnal Enuresis focused on measuring Nocturnal enuresis, PTNS, effect
Eligibility Criteria
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
Sites / Locations
- Abo ElRish children hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Posterior tibial nerve stimulation
Desmopressin
Arm Description
First arm will undergo posterior tibial nerve stimulation ( one session per week for 12 weeks )
Second arm will receive medical treatment (desmopressin 0.2 mg . single evening dose ) for 12 weeks
Outcomes
Primary Outcome Measures
Posterior tibial nerve stimulation Vs desmopressin In children with primary monosymptomatic Nocturnal enuresis
Comparative study to show the effect of posterior tibial nerve stimulation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04545931
Brief Title
Posterior Tibial Nerve Stimulation Vs Desmopressin In Children With Primary Monosymptomatic Nocturnal Enuresis
Acronym
PTNS
Official Title
Posterior Tibial Nerve Stimulation Vs Desmopressin In Children With Primary Monosymptomatic Nocturnal Enuresis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
November 15, 2020 (Anticipated)
Study Completion Date
December 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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-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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Monosymptomatic Nocturnal Enuresis
Keywords
Nocturnal enuresis, PTNS, effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
patient will be allocated to either arms of the study using concealed random allocation method.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Posterior tibial nerve stimulation
Arm Type
Experimental
Arm Description
First arm will undergo posterior tibial nerve stimulation ( one session per week for 12 weeks )
Arm Title
Desmopressin
Arm Type
Experimental
Arm Description
Second arm will receive medical treatment (desmopressin 0.2 mg . single evening dose ) for 12 weeks
Intervention Type
Device
Intervention Name(s)
Posterior tibial nerve stimulation
Other Intervention Name(s)
Urgent PC
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Desmopressin Acetate
Intervention Description
0.2 mg, single evening dose ) for 12 weeks, tapering to half of the dose daily for two weeks before discontinuation
Primary Outcome Measure Information:
Title
Posterior tibial nerve stimulation Vs desmopressin In children with primary monosymptomatic Nocturnal enuresis
Description
Comparative study to show the effect of posterior tibial nerve stimulation
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud S Amar, Resident
Phone
+2001016072715
Email
mahmoudsalahamar199310@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hesham I Mohamed, Lecturer
Phone
+2001005357411
Email
dr_hisham_ibrahim@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany A Morsi, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Abo ElRish children hospital
City
Cairo
ZIP/Postal Code
11865
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morsi
Phone
+2001226125756
Email
hanimorsi@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Posterior Tibial Nerve Stimulation Vs Desmopressin In Children With Primary Monosymptomatic Nocturnal Enuresis
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