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

The Hospital of Vestfold

Status and phase: Completed; Phase 2

Conditions: Overactive Bladder

Treatments: Drug: onabotulinum toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT02735499

Botox instillation study

Details and patient eligibility

About

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

Full 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).

Enrollment: 14 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Treatment with Botox

Experimental group

Description:

Onabotulinum toxin A. 200 units of Botox installed into the bladder by catheter.

Treatment:

Drug: onabotulinum toxin A