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

NCT ID: NCT05911594

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2023-02-14

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.

Conditions

BOTOX; Percutaneous Tibial Nerve Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Solifenacin group

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

Group Type: EXPERIMENTAL

Solifenacin group

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Percutaneous tibial nerve stimulation group

Intervention Type: PROCEDURE

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

Intradetrusor BOTOX group

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

Group Type: EXPERIMENTAL

Intradetrusor BOTOX group

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group

Intervention Type: COMBINATION_PRODUCT

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

Interventions

Solifenacin group

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

Intervention Type: DRUG

Percutaneous tibial nerve stimulation group

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

Intervention Type: PROCEDURE

Intradetrusor BOTOX group

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

Intervention Type: DRUG

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

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Tamer Abd El-Wahab Diab

Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pediatric Urology departments Benha University Hospitals

Banhā, Qalyubiyya, Egypt

Countries

Egypt

Other Identifiers

Rc 14-2-2022

Identifier Type: -

Identifier Source: org_study_id