A Safety and Efficacy study of BOTOXÂ® (Botulinum Toxin Type A) in patients with Urinary Incontinence due to bladder conditions.

Evaluation of the Safety and Effectiveness of BOTOXÂ® (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

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2015/11/006353

Enrollment

250

Registered

2015-11-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Urinary Incontinence

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Patients with urinary incontinence (due to NDO, eg, as a result of SCI or MS, or due to OAB) who have an inadequate response to or are intolerant of an anticholinergic medication

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)Timepoint: At up to 4 months post treatment	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDrThirumalai Velu MD

Allergan Inc

S_Thirumalaivelu@allergan.com91-80-4070-7070

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026