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

Phase 2

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: onabotulinum toxin A

• Registration Number: NCT02735499
• Lead Sponsor: The Hospital of Vestfold

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).

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-12
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-21
• Last Update Posted: 2018-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Botox	onabotulinum toxin A	Onabotulinum toxin A. 200 units of Botox installed into the bladder by catheter.

Primary Outcome Measures

Name	Time	Method
Change in number of leakage episodes	24 hours	Measured with a 24-hour voiding chart

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dept of Ob/Gyn, The Hospital of Vestfold; 🇳🇴 Tonsberg, Norway