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

NCT04075578 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2019-09-04

No results posted yet for this 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)

Conditions

  • Bladder, Overactive

Interventions

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

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Sandrine CAMPAGNE-LOISEAU, PH · CHU de Clermont-Ferrand

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04075578 on ClinicalTrials.gov