BOTOX, Percutaneous Tibial Nerve Stimulation
Conditions
Keywords
Overactive Bladder
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.
Interventions
DRUGSolifenacin group
Patients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment
PROCEDUREPercutaneous tibial nerve stimulation group
Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy
DRUGIntradetrusor BOTOX group
Patients in this group will receive Intradetrusor BOTOX after failure of medical
COMBINATION_PRODUCTIntradetrusor 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
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overactive bladder symptom score | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Perception of Bladder Condition (PPBC) scale | 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. |
| Patients' satisfaction | 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) |
Countries
Egypt
Outcome results
None listed