Clinical trial NCT02735499: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Keywords: onabotulinum toxin A
Urinary bladder
EMDA
iontophoresis
electrophoresis
Urinary incontinence
Lead sponsor: The Hospital of Vestfold
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2016-04-12
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in number of leakage episodes
timeFrame: 24 hours
Secondary outcomes:
measure: Change in grams leakage
timeFrame: 24 hours
measure: Change in number of voids
timeFrame: 24 hours
measure: Change in mean voided volume
timeFrame: 24 hours
measure: Change in Urinary Distress Inventory-6 score (UDI-6)
timeFrame: 6 months
measure: Change in Incontinence Impact Questionnaire-7 score (IIQ-7)
timeFrame: 6 months
measure: Change in International Consultation on Incontinence Questionnaire-Short Form score (ICIQ-SF)
timeFrame: 6 months
measure: Change in flow rate
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tonsberg
country: Norway
facility: Dept of Ob/Gyn, The Hospital of Vestfold
Study officials:
affiliation: Vestfold Hospital
name: Hjalmar A Schiotz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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