IDB Injection Combined With PTNS for Managing Children With OAB Not Responding to Monotherapy

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the outcome of simultaneous intradetrusor BOTOX (IDB) injection and Percutaneous tibial nerve stimulation (PTNS) for management of children with recurrent wetness since at least 6 months.

Detailed Description
-----------------
Overactive bladder is a syndrome characterized by symptoms of urgency, with or without urgency incontinence, usually with increased daytime frequency and nocturia. The Neurogenic or myogenic bladder dysfunction can lead to the symptoms that characterize Overactive bladder. Normal bladder contraction occurs when the muscarinic receptors in the detrusor muscle are stimulated with acetylcholine. Although the pathogenesis of Overactive bladder is not fully explained; sensitization of afferent nerves, deactivation of inhibitory mechanisms, and the emergence of contractions similar to primitive voiding reflexes are shown as pathogenetic mechanisms. Another hypothesis is that the number of intercellular connections among detrusor myocytes increase, and these cells are spontaneously stimulated. In addition to the fact that the etiopathogenesis cannot be explained clearly and due to the intense relationship with the autonomic nervous system, undesirable systemic side effects are common in treatments applied.

Official Title
-----------------
Efficacy and Safety of Intradetrusor BOTOX Injection Combined With Percutaneous Tibial Nerve Stimulation for Managing Children With Overactive Bladder Not Responding to Monotherapy

Conditions
-----------------
BOTOX, Percutaneous Tibial Nerve Stimulation

Intervention / Treatment
-----------------
* Drug: Solifenacin group
* Procedure: Percutaneous tibial nerve stimulation group
* Drug: Intradetrusor BOTOX group
* Combination Product: Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with non-neurogenic overactive bladder defined after exclusion of neurogenic causes not responding to medical treatment for 6 months, and aged of 7-16 years presenting with recurrent night-time with occasional day-time wetness for overactive bladder. Exclusion Criteria: recurrent OAB manifestations within less than 6 months after the previous monotherapy obstructive urinary tract diseases a history of pelvic surgery anatomical abnormalities neurogenic bladder syndromes that affect the bladder functions either current infection that was evidenced by urinalysis and culture or within the last two months systemic diseases inducing liability for wetness

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solifenacin group<br>Patients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment | Drug: Solifenacin group<br>* Patients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment<br>|
| Experimental: Percutaneous tibial nerve stimulation group<br>Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy | Procedure: Percutaneous tibial nerve stimulation group<br>* Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy<br>|
| Experimental: Intradetrusor BOTOX group<br>Patients in this group will receive Intradetrusor BOTOX after the failure of medical therapy | Drug: Intradetrusor BOTOX group<br>* Patients in this group will receive Intradetrusor BOTOX after failure of medical<br>|
| Experimental: Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group<br>Patients in this group will receive Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation after the failure of medical therapy | Combination Product: Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group<br>* Patients in this group will receive Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation after failure of medical<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive bladder symptom score | the Overactive bladder symptom score (OABSS) questionnaire will be calculated which consists of four items; namely, daytime frequency (score: 0-2), night-time frequency (score: 0-3), urgency (score: 0-5), and urgency incontinence (score: 0-5). The results scores were summed and a score of>8 suggesting an overactive bladder | Baseline, 3, 6, 9 and 12 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Perception of Bladder Condition (PPBC) scale | The Patient Perception of Bladder Condition (PPBC) scale will be calculated which includes 6-point describing patient's comment of his/her bladder problems and ranging from 1: Not at all, 2: Some very minor, 3: Some minor, 4: some moderate, 5: severe, 6: many severe problems. | Baseline, 3, 6, 9 and 12 months after the intervention | 
| Patients' satisfaction | The Patients' satisfaction will be assessed by the Likert scale (self-report scale where 0 = strong dissatisfaction, 1 = dissatisfaction, 2 = neutral, 3 = satisfaction, and 4 = strong satisfaction) | Up to the 12-month follow-up period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive Bladder