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

Not Applicable

Completed

• Conditions: Percutaneous Tibial Nerve Stimulation; BOTOX
• Interventions: Drug: Solifenacin group; Procedure: Percutaneous tibial nerve stimulation group; Drug: Intradetrusor BOTOX group; Combination Product: Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group

• Registration Number: NCT05911594
• Lead Sponsor: Benha University

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.

Study Timeline

• Study Start: 2022-02-14
• Primary Completion: 2023-02-14
• Study Completion: 2023-02-14
• Study First Submitted: 2023-05-14
• Study First Submitted QC: 2023-06-17
• Study First Posted: 2023-06-22
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-14
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solifenacin group	Solifenacin group	Patients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment
Percutaneous tibial nerve stimulation group	Percutaneous tibial nerve stimulation group	Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy
Intradetrusor BOTOX group	Intradetrusor BOTOX group	Patients in this group will receive Intradetrusor BOTOX after the failure of medical therapy
Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group	Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group	Patients in this group will receive Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation after the failure of medical therapy

Primary Outcome Measures

Name	Time	Method
Overactive bladder symptom score	Baseline, 3, 6, 9 and 12 months after the intervention	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

Secondary Outcome Measures

Name	Time	Method
Patient Perception of Bladder Condition (PPBC) scale	Baseline, 3, 6, 9 and 12 months after the intervention	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.
Patients' satisfaction	Up to the 12-month follow-up period	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)

Trial Locations

Locations (1)

Pediatric Urology departments Benha University Hospitals; 🇪🇬 Benha, Qalyubiyya, Egypt