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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02735499
• Other study ID #: Botox instillation study
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2018
• Source: The Hospital of Vestfold
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• onabotulinum toxin A
Onabotulinum toxin A is installed into the bladder and EMDA (Electromotive Drug Application) is applied for 30 minutes

Locations

Country	Name	City	State
Norway	Dept of Ob/Gyn, The Hospital of Vestfold	Tonsberg

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital of Vestfold	South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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. Review. — View 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. — View 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

Outcome

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

External Links

•   Final article