A Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in India

Evaluation of the Safety and Effectiveness of BOTOX® (Botulinum Toxin Type A) in the Treatment of Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder: A Phase IV Non-interventional Post-marketing Surveillance Study in India

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02590250

Enrollment

250

Registered

2015-10-29

Start date

2015-12-16

Completion date

2017-08-07

Last updated

2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder, Urinary Incontinence

Brief summary

This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to neurogenic detrusor overactivity or overactive bladder.

Interventions

BIOLOGICALbotulinum toxin Type A

Botulinum toxin Type A treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with urinary incontinence due to NDO or OAB treated with BOTOX® as per local standard of care in clinical practice.

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)	at up to 4 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026