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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT04075578

Collaborator

(none)

Enrollment

Location

10.2

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Jun 26, 2019

Anticipated Primary Completion Date :

May 1, 2020

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Evaluation of the life quality by the KHQ (King's Health Questionnaire) [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

Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire [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.
Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire [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.
Evaluation of the life quality by the KHQ (King's Health Questionnaire) [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
Evaluation of the life quality by the KHQ (King's Health Questionnaire) [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
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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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