Bladder instillation of Botox with iontophoresis for overactive bladder - a pilot study

Phase 1

• Conditions: Overactive bladder; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2015-001680-40-NO
• Lead Sponsor: Vestfold Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-11
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

•OAB/urgency incontinence of at least 3 months duration
•Conservative treatment (medicines, electrical stimulation) has been tried
without sufficient benefit
•There is indication for injection treatment with Botox®
•More than 3months since any previous treatment with Botox®

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

•Mixed incontinence with predominant stress component
•Age below 18 years
•Insuffcient understanding of Norwegian and / or unable to fill out the
necessary forms
•Ongoing urinary tract infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified