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

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

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

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: onabotulinum toxin A

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• Norway
  • Tonsberg, Norway, N-3103
    • Dept of Ob/Gyn, The Hospital of Vestfold

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with Botox; Onabotulinum toxin A. 200 units of Botox installed into the bladder by catheter.	Drug: onabotulinum toxin A; Onabotulinum toxin A is installed into the bladder and EMDA (Electromotive Drug Application) is applied for 30 minutes; Other Names: Botox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of leakage episodes	Measured with a 24-hour voiding chart	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Hospital of Vestfold
• Collaborators: South-Eastern Norway Regional Health Authority
• Investigators: Principal Investigator: Hjalmar A Schiotz, MD, PhD, Vestfold Hospital

Publications and helpful links

General Publications

• Duthie JB, Vincent M, Herbison GP, Wilson DI, Wilson D. Botulinum toxin injections for adults with overactive bladder syndrome. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD005493. doi: 10.1002/14651858.CD005493.pub3.
• Kajbafzadeh AM, Ahmadi H, Montaser-Kouhsari L, Sharifi-Rad L, Nejat F, Bazargan-Hejazi S. Intravesical electromotive botulinum toxin type A administration--part II: Clinical application. Urology. 2011 Feb;77(2):439-45. doi: 10.1016/j.urology.2010.06.003. Epub 2010 Aug 30.
• Schiøtz HA, Mai HT, Zabielska R. Intravesical Electromotive Botulinum Toxin in Women with Overactive Bladder - a pilot study. AJGO 2017; 2: 4-10. https://www.arcjournals.org/pdfs/ajgo/v2-i2/2.pdf

Helpful Links

• Final article

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: April 6, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Urinary incontinence; iontophoresis; onabotulinum toxin A; Urinary bladder; EMDA; electrophoresis
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: Botox instillation study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No