NCT05911594

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 7 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• BOTOX
• Percutaneous Tibial Nerve Stimulation

Interventions

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

Timeline

• Start date: 2022-02-14
• Primary completion: 2023-02-14
• Completion: 2023-02-14
• First posted: 2023-06-22
• Last updated: 2023-08-15

Locations

1 site across 1 country: Egypt