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

Benha University

Status: Completed

Conditions: Percutaneous Tibial Nerve Stimulation; BOTOX

Treatments: Drug: Intradetrusor BOTOX group; Drug: Solifenacin group; Combination Product: Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group; Procedure: Percutaneous tibial nerve stimulation group

Study type: Interventional

Funder types: Other

Identifiers

NCT05911594

Rc 14-2-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 7 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 4 patient groups

Solifenacin group

Experimental group

Description:

Patients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment

Treatment:

Drug: Solifenacin group

Percutaneous tibial nerve stimulation group

Experimental group

Description:

Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy

Treatment:

Procedure: Percutaneous tibial nerve stimulation group

Intradetrusor BOTOX group

Experimental group

Description:

Patients in this group will receive Intradetrusor BOTOX after the failure of medical therapy

Treatment:

Drug: Intradetrusor BOTOX group

Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group

Experimental group

Description:

Patients in this group will receive Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation after the failure of medical therapy

Treatment:

Combination Product: Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group