NCT02735499

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

April 6, 2016

Last Update Submit

November 21, 2018

Conditions

Overactive Bladder

Keywords

onabotulinum toxin AUrinary bladderEMDAiontophoresiselectrophoresisUrinary incontinence

Outcome Measures

Primary Outcomes (1)

  • Change in number of leakage episodes

    Measured with a 24-hour voiding chart

    24 hours

Secondary Outcomes (7)

  • Change in grams leakage

    24 hours

  • Change in number of voids

    24 hours

  • Change in mean voided volume

    24 hours

  • Change in Urinary Distress Inventory-6 score (UDI-6)

    6 months

  • Change in Incontinence Impact Questionnaire-7 score (IIQ-7)

    6 months

  • +2 more secondary outcomes

Study Arms (1)

Treatment with Botox

EXPERIMENTAL

Onabotulinum toxin A. 200 units of Botox installed into the bladder by catheter.

Drug: onabotulinum toxin A

Interventions

onabotulinum toxin ADRUG

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

Also known as: Botox
Treatment with Botox

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age below 18 years
  • Mixed incontinence with predominant stress component
  • Insufficient understanding of Norwegian and / or unable to fill out the necessary forms
  • Any contraindication stated in the Summary of product characteristics (SPC) for Botox

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Ob/Gyn, The Hospital of Vestfold

Tønsberg, N-3103, Norway

Location

Related 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;2011(12):CD005493. doi: 10.1002/14651858.CD005493.pub3.

    PMID: 22161392BACKGROUND

  • 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.

    PMID: 20800886BACKGROUND

  • 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

    RESULT

Related Links

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence

Interventions

onabotulinum toxin ABotulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination Disorders

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Hjalmar A Schiotz, MD, PhD

    Vestfold Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant gynecologist

Study Record Dates

First Submitted

April 6, 2016

First Posted

April 12, 2016

Study Start

March 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 26, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)