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

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Bladder, Overactive

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

Study type: Observational

Funder types: Other

Identifiers

NCT04075578

2019-A01296-51 (Other Identifier)

RNI 2019 CAMPAGNE-LOISEAU

Details and patient eligibility

About

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)

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

female with urinary incontinence

Description:

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

Treatment:

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