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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solifenacin group | Experimental | 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 | Experimental | Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy |
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| Intradetrusor BOTOX group | Experimental | Patients in this group will receive Intradetrusor BOTOX after the failure of medical therapy |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin group | Drug | Patients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Perception of Bladder Condition (PPBC) scale | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Urology departments Benha University Hospitals | Banhā | Qalyubiyya | 13511 | Egypt |
The study will be available under a reasonable request from the corresponding author
One year after the end of the study
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| Percutaneous tibial nerve stimulation group | Procedure | Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy |
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| Intradetrusor BOTOX group | Drug | Patients in this group will receive Intradetrusor BOTOX after failure of medical |
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| 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 |
|
| Patients' satisfaction | 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 |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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