Back to resultsInstillation of Botox in the Bladder in Women With Overactive Bladder (OAB)
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
onabotulinum toxin A
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring onabotulinum toxin A, Urinary bladder, EMDA, iontophoresis, electrophoresis, Urinary incontinence
Eligibility 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
Sites / Locations
- Dept of Ob/Gyn, The Hospital of Vestfold
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with Botox
Arm Description
Onabotulinum toxin A. 200 units of Botox installed into the bladder by catheter.
Outcomes
Primary Outcome Measures
Change in number of leakage episodes
Measured with a 24-hour voiding chart
Secondary Outcome Measures
Change in grams leakage
Measured with a 24-hour voiding chart
Change in number of voids
Measured with a 24-hour voiding chart
Change in mean voided volume
Measured with a 24-hour voiding chart
Change in Urinary Distress Inventory-6 score (UDI-6)
Questionnaire
Change in Incontinence Impact Questionnaire-7 score (IIQ-7)
Questionnaire
Change in International Consultation on Incontinence Questionnaire-Short Form score (ICIQ-SF)
Questionnaire
Change in flow rate
Measured by flowmetry
Full Information
NCT ID
NCT02735499
First Posted
April 6, 2016
Last Updated
November 21, 2018
Sponsor
The Hospital of Vestfold
Collaborators
South-Eastern Norway Regional Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT02735499
Brief Title
Instillation of Botox in the Bladder in Women With Overactive Bladder (OAB)
Official Title
Bladder Instillation of Botox With EMDA for OAB - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital of Vestfold
Collaborators
South-Eastern Norway Regional Health Authority
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
onabotulinum toxin A, Urinary bladder, EMDA, iontophoresis, electrophoresis, Urinary incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Botox
Arm Type
Experimental
Arm Description
Onabotulinum toxin A. 200 units of Botox installed into the bladder by catheter.
Intervention Type
Drug
Intervention Name(s)
onabotulinum toxin A
Other Intervention Name(s)
Botox
Intervention Description
Onabotulinum toxin A is installed into the bladder and EMDA (Electromotive Drug Application) is applied for 30 minutes
Primary Outcome Measure Information:
Title
Change in number of leakage episodes
Description
Measured with a 24-hour voiding chart
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Change in grams leakage
Description
Measured with a 24-hour voiding chart
Time Frame
24 hours
Title
Change in number of voids
Description
Measured with a 24-hour voiding chart
Time Frame
24 hours
Title
Change in mean voided volume
Description
Measured with a 24-hour voiding chart
Time Frame
24 hours
Title
Change in Urinary Distress Inventory-6 score (UDI-6)
Description
Questionnaire
Time Frame
6 months
Title
Change in Incontinence Impact Questionnaire-7 score (IIQ-7)
Description
Questionnaire
Time Frame
6 months
Title
Change in International Consultation on Incontinence Questionnaire-Short Form score (ICIQ-SF)
Description
Questionnaire
Time Frame
6 months
Title
Change in flow rate
Description
Measured by flowmetry
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hjalmar A Schiotz, MD, PhD
Organizational Affiliation
Vestfold Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Ob/Gyn, The Hospital of Vestfold
City
Tonsberg
ZIP/Postal Code
N-3103
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22161392
Citation
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.
Results Reference
background
PubMed Identifier
20800886
Citation
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.
Results Reference
background
Citation
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
Results Reference
result
Links:
URL
http://dx.doi.org/10.20431/2456-0561.0202002
Description
Final article
Learn more about this trial
Instillation of Botox in the Bladder in Women With Overactive Bladder (OAB)
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