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

The Hospital of Vestfold14 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Overactive Bladder

Interventions

onabotulinum toxin ADRUG

Onabotulinum toxin A is installed into the bladder and EMDA (Electromotive Drug Application) is applied for 30 minutes

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept of Ob/Gyn, The Hospital of Vestfold

Tønsberg, Norway

Outcomes

Primary Outcomes

Change in number of leakage episodes

Measured with a 24-hour voiding chart

Time frame: 24 hours

Secondary Outcomes

Change in grams leakage

Measured with a 24-hour voiding chart

Time frame: 24 hours

Change in number of voids

Measured with a 24-hour voiding chart

Time frame: 24 hours

Change in mean voided volume

Measured with a 24-hour voiding chart

Time frame: 24 hours

Change in Urinary Distress Inventory-6 score (UDI-6)

Questionnaire

Time frame: 6 months

Change in Incontinence Impact Questionnaire-7 score (IIQ-7)

Questionnaire

Time frame: 6 months

Change in International Consultation on Incontinence Questionnaire-Short Form score (ICIQ-SF)

Questionnaire

Time frame: 6 months

Change in flow rate

Measured by flowmetry

Time frame: 4 weeks

Data from ClinicalTrials.gov

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