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

Study Overview
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Brief Summary
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Instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder

Detailed Description
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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).

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

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: onabotulinum toxin A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Botox<br>Onabotulinum toxin A. 200 units of Botox installed into the bladder by catheter. | Drug: onabotulinum toxin A<br>* Onabotulinum toxin A is installed into the bladder and EMDA (Electromotive Drug Application) is applied for 30 minutes<br>* Other names: Botox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of leakage episodes | Measured with a 24-hour voiding chart | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in grams leakage | Measured with a 24-hour voiding chart | 24 hours | 
| Change in number of voids | Measured with a 24-hour voiding chart | 24 hours | 
| Change in mean voided volume | Measured with a 24-hour voiding chart | 24 hours | 
| Change in Urinary Distress Inventory-6 score (UDI-6) | Questionnaire | 6 months | 
| Change in Incontinence Impact Questionnaire-7 score (IIQ-7) | Questionnaire | 6 months | 
| Change in International Consultation on Incontinence Questionnaire-Short Form score (ICIQ-SF) | Questionnaire | 6 months | 
| Change in flow rate | Measured by flowmetry | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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onabotulinum toxin A, Urinary bladder, EMDA, iontophoresis, electrophoresis, Urinary incontinence