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

Bladder, Overactive Clinical Trial

— TOX50IUU  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075578
• Other study ID #: RNI 2019 CAMPAGNE-LOISEAU
• Secondary ID: 2019-A01296-51
• Status: Recruiting
• Start date: June 26, 2019
• Est. completion date: May 2020

Study information

• Verified date: August 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder, Overactive
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the life quality by the KHQ (King's Health Questionnaire)	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	Week 6
Secondary	Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire	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.	Week 2
Secondary	Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire	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.	Week 12
Secondary	Evaluation of the life quality by the KHQ (King's Health Questionnaire)	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	Week 2
Secondary	Evaluation of the life quality by the KHQ (King's Health Questionnaire)	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	Week 12
Secondary	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	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.	Day 1