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Completed

NCT Number: NCT05911594

IDB Injection Combined With PTNS for Managing Children With OAB 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.

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Key information

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Urology departments Benha University Hospitals

Banhā, Qalyubiyya, 13511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solifenacin group

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

Procedure

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

Intradetrusor BOTOX group

Drug

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

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 22, 2023
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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