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

NCT05911594 | Completed

• 1 other identifier: Rc 14-2-2022
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

BOTOX; Percutaneous Tibial Nerve Stimulation

Keywords

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Overactive bladder symptom score

  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

  Baseline, 3, 6, 9 and 12 months after the intervention

Secondary Outcomes (2)

• Patient Perception of Bladder Condition (PPBC) scale

  Baseline, 3, 6, 9 and 12 months after the intervention

• Patients' satisfaction

  Up to the 12-month follow-up period

Study Arms (4)

Solifenacin group

EXPERIMENTAL

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

Drug: Solifenacin group

Percutaneous tibial nerve stimulation group

EXPERIMENTAL

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

Procedure: Percutaneous tibial nerve stimulation group

Intradetrusor BOTOX group

EXPERIMENTAL

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

Drug: Intradetrusor BOTOX group

Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group

EXPERIMENTAL

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

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

Interventions

Solifenacin group DRUG

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

Solifenacin group

Percutaneous tibial nerve stimulation group PROCEDURE

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

Percutaneous tibial nerve stimulation group

Intradetrusor BOTOX group DRUG

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

Intradetrusor BOTOX group

Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group COMBINATION_PRODUCT

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

Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• aged of 7-16 years
• presenting with recurrent night-time with occasional day-time wetness for overactive bladder.

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Pediatric Urology departments Benha University Hospitals

Banhā, Qalyubiyya, 13511, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: June 22, 2023
• Study Start: February 14, 2022
• Primary Completion: February 14, 2023
• Study Completion: February 14, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study

Locations

EG (1)