Last updated: 08/06/2025 12:40:17
Effectiveness and safety of BOTOX® in participants with overactive bladder and neurogenic bladder
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: BOTOX for Injection General Drug Use Investigation (Overactive Bladder and Neurogenic Bladder)
Trial description: This study will evaluate the safety and effectiveness of BOTOX in BOTOX-naïve participants with overactive bladder (OAB) and neurogenic bladder (NB) in daily clinical practice. In this study, incidences of urinary tract infection (UTI) and urinary retention (UR) as well as the risk factors affecting incidences of UTI and UR after BOTOX treatment will be evaluated. The study will target to capture data on approximately 500 participants with OAB and NB from January 2020 to April 2023. The observation period per participant will be a maximum of one year (48 weeks) from the initial date of BOTOX administration. BOTOX is a registered trademark of Allergan labs.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with adverse drug reactions (ADRs)/infections after administration of BOTOX
Timeframe: Up to 48 weeks
Number of participants with UTI after administration of BOTOX
Timeframe: Up to 48 weeks
Number of participants with UR after administration of BOTOX
Timeframe: Up to 48 weeks
Number of participants with identified risk factors affecting occurrences of UTI
Timeframe: Up to 48 weeks
Number of participants with identified risk factors affecting occurrences of UR
Timeframe: Up to 48 weeks
Numbers of responders after administration of BOTOX based on global assessment of effectiveness
Timeframe: Up to 48 weeks
Change from Baseline in overactive bladder symptom score (OABSS) after administration of BOTOX in participants with OAB
Timeframe: Baseline and Up to 48 weeks
Change from Baseline in number of times to experience urinary incontinence (UI) episodes after administration of BOTOX in participants with NB
Timeframe: Baseline and Up to 48 weeks
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
500
Primary completion date:
2024-30-08
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Urinary Bladder, Overactive
Product
OnabotulinumtoxinA
Collaborators
Not applicable
Study date(s)
June 2020 to August 2024
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- BOTOX naïve participants with OAB and NB
- Not available
Inclusion and exclusion criteria
Inclusion criteria:
- BOTOX naïve participants with OAB and NB
Exclusion criteria:
- Not available
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2024-30-08
Actual study completion date
2024-30-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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