Clinical trial NCT05911594: IDB Injection Combined With PTNS for Managing Children With OAB Not Responding to Monotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BOTOX
Percutaneous Tibial Nerve Stimulation
Keywords: Overactive Bladder
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 128
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overactive bladder symptom score
timeFrame: Baseline, 3, 6, 9 and 12 months after the intervention
Secondary outcomes:
measure: Patient Perception of Bladder Condition (PPBC) scale
timeFrame: Baseline, 3, 6, 9 and 12 months after the intervention
measure: Patients' satisfaction
timeFrame: Up to the 12-month follow-up period
Other outcomes:
Locations:
city: Benha
country: Egypt
facility: Pediatric Urology departments Benha University Hospitals
state: Qalyubiyya
Study officials:
References: