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

Last updated: August 30, 2019
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04075578
RNI 2019 CAMPAGNE-LOISEAU
2019-A01296-51
  • Ages > 18
  • Female

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female

  • Age ≥ 18 yo

  • Refractory idiopathic overactive bladder

  • Eligibility to an injection treatment

  • Capacity to perform clean intermittent catheterization

Exclusion

Exclusion Criteria:

  • Protected adults (under trusteeship, guardianship or judicial protection)

  • Patients under anticholinergics for an other desease (psychiatric, neurologic forexample)

  • Known hypersensitivity or at risk of hypersensitivity to botulinum toxin type A likemyasthenic 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

Study Design

Total Participants: 60
Study Start date:
June 26, 2019
Estimated Completion Date:
May 31, 2020

Study 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.

Connect with a study center

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003
    France

    Active - Recruiting

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