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Evaluation of Professional Practices in the Treatment of Refractory Idiopathic Overactive Bladder at the Dose of 50 Units (TOX50IUU) (TOX50IUU)

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ClinicalTrials.gov Identifier: NCT04075578
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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)

Condition or disease Intervention/treatment
Bladder, Overactive Drug: OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-States

Detailed Description:

Currently, Botox injection is one of the second-line treatments for urinary incontinence by idiopathic overactive bladder. Multiple studies have shown that Botox at the dose of 50UI is effective but not for a long time. Maximum efficiency is about two weeks and until about twelve weeks compared to the dose between 100UI and 300UI that shown an efficiency until twenty-four at thirty-six weeks. But it's not without consequence since the side effects are more numerous increasing the dose. The most frequent are urinary retention with necessary to perform clean intermittent catheterization and urinary infection.

This dose at 50UI is therefore more a test to assess the patient's tolerance to the product, as recommended by the product marketing authorization.

So, through this evaluation of professional practices, investigators would like to evaluate the patient satisfaction treated in hospital, with a first dose at 50UI.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Professional Practices in Botulinum Toxin Type A Intradetrusor Injection, at the Dose of 50 Units for the Treatment of Urinary Incontinence by Refractory Idiopathic Overactive Bladder
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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




Primary Outcome Measures :
  1. Evaluation of the life quality by the KHQ (King's Health Questionnaire) [ Time Frame: Week 6 ]
    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


Secondary Outcome Measures :
  1. Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire [ Time Frame: Week 2 ]
    Patients will have to answer the questionnaires at home depending the symptoms that they feel. The data will then be collected by phone. The data will then be collected and analysed.

  2. Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire [ Time Frame: Week 12 ]
    Patients will have to answer the questionnaires at home depending the symptoms that they feel. The data will then be collected during the postoperative consultation. The data will then be collected and analysed.

  3. Evaluation of the life quality by the KHQ (King's Health Questionnaire) [ Time Frame: Week 2 ]
    Patients will have to answer the questionnaires at home depending the symptoms that they feel. The data will then be collected by phone at 2 weeks. The data will then be collected and analysed

  4. Evaluation of the life quality by the KHQ (King's Health Questionnaire) [ Time Frame: Week 12 ]
    Patients will have to answer the questionnaires at home depending the symptoms that they feel. The data will then be collected during the postoperative consultation. The data will then be collected and analysed

  5. 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 [ Time Frame: Day 1 ]
    Patients will have to answer the questionnaire before the return home just after the injection session to assess their experience concerning local anaesthesia and outpatient management.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075578


Contacts
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Contact: Lise Laclautre +33473754963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    +33473754963    promo_interne_drci@chu-clermontferrand.fr   
Principal Investigator: Sandrine CAMPAGNE-LOISEAU         
Sub-Investigator: Sandra CURINIER         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Sandrine CAMPAGNE-LOISEAU, PH CHU de Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04075578    
Other Study ID Numbers: RNI 2019 CAMPAGNE-LOISEAU
2019-A01296-51 ( Other Identifier: ANSM )
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
idiopathic overactive bladder
Botox
Onabotulinum toxinA
50 units
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents