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

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital of Vestfold
• Collaborator: South-Eastern Norway Regional Health Authority
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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