NCT02735499

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: The Hospital of Vestfold · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	onabotulinum toxin A	Onabotulinum toxin A is installed into the bladder and EMDA (Electromotive Drug Application) is applied for 30 minutes

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-04-12
• Last updated: 2018-11-26

Locations

1 site across 1 country: Norway