Instillation of Botox in the Bladder in Women With Overactive Bladder (OAB)

Bladder Instillation of Botox With EMDA for OAB - a Pilot Study

Instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder

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).

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