Bladder, OveractiveTOX50IUUNCT04075578
Evaluation of Professional Practices in the Treatment of Refractory Idiopathic Overactive Bladder at the Dose of 50 Units (TOX50IUU)
An observational study of Bladder, Overactive, run by University Hospital, Clermont-Ferrand at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bladder, Overactive
- What is being tested?
- OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-States
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2019to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female ≥ 18 yo, 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
Who may be able to join
- Female
- Age ≥ 18 yo
- Refractory idiopathic overactive bladder
- Eligibility to an injection treatment
- Capacity to perform clean intermittent catheterization
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Lise LACLAUTRE, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Sandrine CAMPAGNE-LOISEAU
About this study
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
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)
Read the 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.
- Conditions
- Bladder, Overactive
- Being tested
- OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-States
- Keywords
- idiopathic overactive bladder, Botox, Onabotulinum toxinA, 50 units
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-StatesDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-States |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 6
Secondary outcomes (5)
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.
Measured: Week 2
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.
Measured: Week 12
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
Measured: Week 2
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
Measured: Week 12
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start26 Jun 2019
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder, OveractiveStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine CAMPAGNE-LOISEAU, PH, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075578
- Sponsor's protocol ID
- RNI 2019 CAMPAGNE-LOISEAU
- Other IDs
- 2019-A01296-51
- Acronym
- TOX50IUU
- Status last verified
- Aug 2019
- First submitted
- 29 Aug 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04075578
- Acronym / sponsor ID
- TOX50IUU / RNI 2019 CAMPAGNE-LOISEAU
- Conditions
- Bladder, Overactive
- Keywords
- idiopathic overactive bladder, Botox, Onabotulinum toxinA, 50 units
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| female with urinary incontinence | – | Drug: OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-StatesFemale ≥ 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female ≥ 18 yo, 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
Key inclusion criteria (5 listed)
- Female
- Age ≥ 18 yo
- Refractory idiopathic overactive bladder
- Eligibility to an injection treatment
- Capacity to perform clean intermittent catheterization
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-StatesBotox® 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 | Drug | female with urinary incontinence |
Primary outcome
Evaluation of the life quality by the KHQ (King's Health Questionnaire)
Time frame: 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
5 secondary outcomes
Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire
Time frame: Week 2
Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire
Time frame: Week 12
Evaluation of the life quality by the KHQ (King's Health Questionnaire)
Time frame: Week 2
Evaluation of the life quality by the KHQ (King's Health Questionnaire)
Time frame: Week 12
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
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine CAMPAGNE-LOISEAU, PH principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder, Overactive, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the life quality by the KHQ (King's Health Questionnaire) (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.