Instillation of Botox in the Bladder in Women With Overac... | NCT02735499

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

NCT02735499

Sponsor

The Hospital of Vestfold

Status

Completed

Last Update Posted

Nov 26, 2018Actual

Enrollment

14Actual

Phase

Phase 2

Conditions

Overactive Bladder

Interventions

onabotulinum toxin A

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Apr 6, 2016

First Submission Date that Met QC Criteria

Apr 6, 2016

First Posted Date

Apr 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2018

Last Update Posted Date

Nov 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Hjalmar A Schiotz, MD, PhD, Senior consultant gynecologist, The Hospital of VestfoldPrincipal Investigator

Lead Sponsor

The Hospital of VestfoldOTHER

Collaborators

Name	Class
South-Eastern Norway Regional Health Authority	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment with Botox	Experimental	Onabotulinum toxin A. 200 units of Botox installed into the bladder by catheter.	Drug: onabotulinum toxin A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
onabotulinum toxin A	Drug	Onabotulinum toxin A is installed into the bladder and EMDA (Electromotive Drug Application) is applied for 30 minutes	Treatment with Botox

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hjalmar A Schiotz, MD, PhD	Vestfold Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Ob/Gyn, The Hospital of Vestfold		Tønsberg		N-3103	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22161392	Background	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;2011(12):CD005493. doi: 10.1002/14651858.CD005493.pub3.
20800886	Background	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.

ID	Term
D053201	Urinary Bladder, Overactive
D014549	Urinary Incontinence

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
C000629279	onabotulinum toxin A
D019274	Botulinum Toxins, Type A

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases