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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-26

Study Completion Date

2020-05-31

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Bladder, Overactive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No