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A non-intervention cohort study on the use of Botulinum Neurotoxin Type A (BoNT-A) in Paediatric Non-neurogenic Therapy Resistant Overactive Bladder (OAB). Primary endpoint was the reduction of urinary incontinence.
The investigators wanted to cunduct an analysis of children with urinary incontinence who received intradetrusor injection of BoNT-A in the period 01.01.2016 to 31.12.2020 at their centre. All patients were refractory to standard urotherapy, anticholinergics, mirabegron and combination of treatments. Patients with neurogenic bladder were excluded.
Primary endpoints were the effect on the frequency of urinary incontinence episodes. Secondary endpoints included urodynamic parameters and uroflow characteristics in relation to side effects and response to treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main group | Children with OAB, who underwent intradetrusor BoNT-A-injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradetrusor BoNT-A | Procedure | For intravesical injections, BoNT-A (Allergan, Irvine, CA, USA) was diluted in 0.9% saline to 10 93 international units/ml. Multiple injections were distributed throughout the detrusor, using a 94 transurethral 23-gauge injection needle under rigid cystoscopic guidance (9.8 Fr paediatric 95 cystoscope) at 10 units/kg to a maximum of 300 units. All injections were performed under general 96 anaesthesia with antibiotic prophylaxis given intra-operative as single dose intravenously. |
| Measure | Description | Time Frame |
|---|---|---|
| Incontinence episodes | Change of incontinence episodes | 1 month after treatment until request for additional treatment (up to 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Response | Identification of predictors of response | 1 month after treatment until request for additional treatment (up to 12 months) |
| Side effects | Identification of predictors of side effects |
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Inclusion Criteria:
Exclusion Criteria:
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Children refractory to standard treatment for OAB and incontinence.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospiral | Aarhus | Region Midt | 8200 | Denmark |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053207 | Diurnal Enuresis |
| D053206 | Nocturnal Enuresis |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| 1 month after treatment |
| 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 |
| D004775 | Enuresis |
| D014555 | Urination Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |