NCT04075578

Brief Summary

Considering that the 2013 Hermieu's guidelines differs from the product marketing authorization delivered in November 2014, the primary endpoints is to evaluate life quality by questionnaires at the baseline time, and after two, six and twelve weeks of treatment in patients suffer from urinary incontinence by refractory idiopathic overactive bladder and treated by Botox® at the dose of 50UI (international units)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 26, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

September 4, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

August 29, 2019

Last Update Submit

August 30, 2019

Conditions

Bladder, Overactive

Keywords

idiopathic overactive bladderBotoxOnabotulinum toxinA50 units

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the life quality by the KHQ (King's Health Questionnaire)

    Patients will have to answer the questionnaire at home depending the symptoms that they feel at 6 weeks. The data will then be collected by phone

    Week 6

Secondary Outcomes (5)

  • Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire

    Week 2

  • Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire

    Week 12

  • Evaluation of the life quality by the KHQ (King's Health Questionnaire)

    Week 2

  • Evaluation of the life quality by the KHQ (King's Health Questionnaire)

    Week 12

  • Patient experience's evaluation of the local anaesthesia and outpatient care thanks to the EVAN-LR (Evaluation du Vécu de l'ANesthésie Loco-Régionale) questionnaire

    Day 1

Study Arms (1)

female with urinary incontinence

Female ≥ 18 years, suffers from urinary incontinence by idiopathic overactive bladder, inadequately treated by 2 anticholinergic medicines during a period of 3 months for each of them or stopped for intolerance or adverse events

Drug: OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-States

Interventions

OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-StatesDRUG

Botox® intradetrusor injections, with a rigid cystoscope, under local anaesthesia performed by Lidocaïne 2% diluted in 30ml of bicarbonate 14‰. 20 injections of 0,5ml each will be heterogeneously administrated into the bladder wall, sparing the trigone

female with urinary incontinence

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female ≥ 18 yo, suffers from urinary incontinence by idiopathic overactive bladder, inadequately treated by 2 anticholinergic medicines during a period of 3 months for each of them or stopped for intolerance or adverse events

You may qualify if:

  • Female
  • Age ≥ 18 yo
  • Refractory idiopathic overactive bladder
  • Eligibility to an injection treatment
  • Capacity to perform clean intermittent catheterization

You may not qualify if:

  • Protected adults (under trusteeship, guardianship or judicial protection)
  • Patients under anticholinergics for an other desease (psychiatric, neurologic for example)
  • Known hypersensitivity or at risk of hypersensitivity to botulinum toxin type A like myasthenic syndrom
  • Patients who suffer from an overactive bladder with a known cause (neurological, urological condition)
  • urinary infection under treatment \< 48 hours before Botox® injections
  • Suspicious looking bladder requiring biopsies during the cystoscopy
  • Pregnant or breastfeeding women
  • Language barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum 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 Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Sandrine CAMPAGNE-LOISEAU, PH

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2019

First Posted

August 30, 2019

Study Start

June 26, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

September 4, 2019

Record last verified: 2019-08

Locations

FR(1)