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

August 14, 2023 updated by: Tamer Abd El-Wahab Diab, Benha University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalyubiyya
      • Benha, Qalyubiyya, Egypt, 13511
        • Pediatric Urology departments Benha University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solifenacin group
Patients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment
Drug: Solifenacin group
Patients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment
Experimental: Percutaneous tibial nerve stimulation group
Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy
Procedure: Percutaneous tibial nerve stimulation group
Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy
Experimental: Intradetrusor BOTOX group
Patients in this group will receive Intradetrusor BOTOX after the failure of medical therapy
Drug: Intradetrusor BOTOX group
Patients in this group will receive Intradetrusor BOTOX after failure of medical
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive bladder symptom score
Time Frame: Baseline, 3, 6, 9 and 12 months after the intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Perception of Bladder Condition (PPBC) scale
Time Frame: Baseline, 3, 6, 9 and 12 months after the intervention
The Patient Perception of Bladder Condition (PPBC) scale will be calculated which includes 6-point describing patient's comment of his/her bladder problems and ranging from 1: Not at all, 2: Some very minor, 3: Some minor, 4: some moderate, 5: severe, 6: many severe problems.
Baseline, 3, 6, 9 and 12 months after the intervention
Patients' satisfaction
Time Frame: Up to the 12-month follow-up period
The Patients' satisfaction will be assessed by the Likert scale (self-report scale where 0 = strong dissatisfaction, 1 = dissatisfaction, 2 = neutral, 3 = satisfaction, and 4 = strong satisfaction)
Up to the 12-month follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2022

Primary Completion (Actual)

February 14, 2023

Study Completion (Actual)

February 14, 2023

Study Registration Dates

First Submitted

May 14, 2023

First Submitted That Met QC Criteria

June 17, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rc 14-2-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study will be available under a reasonable request from the corresponding author

IPD Sharing Time Frame

One year after the end of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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