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NCT04075578: TOX50IUU
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
trial testing OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-States in Bladder, Overactive in 60 participants. Status unknown.
1 May 2020
Quick facts
| Lead sponsor | University Hospital, Clermont-Ferrand |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 26 June 2019 |
| Primary completion | 1 May 2020 |
| Estimated completion | 1 May 2020 |
| Sites | 1 location across France |
Drugs / interventions tested
- OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-States — full drug profile →
Conditions studied
- Bladder, Overactive — all drugs for Bladder, Overactive →
Sponsor
University Hospital, Clermont-Ferrand
Who can join
18 and older, female only, with Bladder, Overactive. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04075578
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04075578 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Clermont-Ferrand
- Last refreshed: 30 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04075578.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing