Overactive Bladder
Conditions
Keywords
onabotulinum toxin A, Urinary bladder, EMDA, iontophoresis, electrophoresis, Urinary incontinence
Brief summary
Instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder
Detailed description
Pilot study to evaluate the effect of instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder using Electromotive Drug Application (EMDA) in women with overactive bladder. 15 women with therapy-resistant OAB will be included. All patients must be qualified for conventional cystoscopic Botox injection. The study is not randomized or blinded. Follow-up time is six months with voiding charts and three questionnaires (Urinary Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) as well as a satisfaction with treatment Visual analog scale (VAS).
Interventions
Onabotulinum toxin A is installed into the bladder and EMDA (Electromotive Drug Application) is applied for 30 minutes
Sponsors
South-Eastern Norway Regional Health Authority
The Hospital of Vestfold
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent form signed * OAB/urgency incontinence of at least 3 months duration * Conservative treatment (medicines, electrical stimulation) has been tried without sufficient benefit * There is indication for cystoscopic injection treatment with Botox® * More than 3 months since any previous treatment with Botox® * Detrusor overactivity documented by cystometry is desirable, but not obligatory
Exclusion criteria
* Age below 18 years * Mixed incontinence with predominant stress component * Insufficient understanding of Norwegian and / or unable to fill out the necessary forms * Ongoing urinary tract infection (UTI) (defined as positive urine stix (nitrite and leucocytes) with symptoms of UTI) must be treated before inclusion. * Any contraindication stated in the Summary of product characteristics (SPC) for Botox
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of leakage episodes | 24 hours | Measured with a 24-hour voiding chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of voids | 24 hours | Measured with a 24-hour voiding chart |
| Change in mean voided volume | 24 hours | Measured with a 24-hour voiding chart |
| Change in Urinary Distress Inventory-6 score (UDI-6) | 6 months | Questionnaire |
| Change in grams leakage | 24 hours | Measured with a 24-hour voiding chart |
| Change in International Consultation on Incontinence Questionnaire-Short Form score (ICIQ-SF) | 6 months | Questionnaire |
| Change in flow rate | 4 weeks | Measured by flowmetry |
| Change in Incontinence Impact Questionnaire-7 score (IIQ-7) | 6 months | Questionnaire |
Countries
Norway
Outcome results
None listed