Study identification

PURI

https://redirect.ema.europa.eu/resource/22807

EU PAS number

EUPAS16153

Study ID

22807

Official title and acronym

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

DARWIN EU® study

No

Study countries

India

Study description

Objectives The purpose of this phase IV post-marketing surveillance study is to evaluate the safety and effectiveness of BOTOX for the treatment of patients with urinary incontinence due to either NDO or OAB through active surveillance under routine clinical practice after the launch of BOTOX in India. Study Population Adult patients (≥ 18 years of age) with urinary incontinence due to NDO or due to OAB who have an inadequate response to or are intolerant of an anticholinergic medication as evaluated and determined by treating physicians Study Sites Contracted specialists in the applicable departments in hospitals and clinics Patient Recruitment All eligible patients treated with BOTOX at the relevant hospital(s) to ensure unbiased enrollment of patients during the agreed surveillance period. Study Size Approximately 250 patients with NDO or OAB who have received BOTOX injection(s) for the treatment of urinary incontinence. Only those patients who have consented to the study by signed Informed Consent Form (ICF) will be included in the study. Follow-up Safety and effectiveness details will be collected during the period from 1 to 4 months after BOTOX treatment. Study Duration 1 year after study start date, however, the actual enrollment status will be communicated to DCGI and if needed, additional time period would be sought. Data Collection Investigators will collect the required information on enrolled patients utilizing Allergan provided case report forms (CRFs) once the contract has been executed. Safety Variables All AEs that occur during BOTOX administration and/or after BOTOX administration during the follow-up period will be collected regardless of causal relationship to BOTOX. Effectiveness Variables The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) instrument will be used to evaluate effectiveness Analysis Only descriptive analyses will be performed.

Study status

Finalised
Research institutions and networks

Institutions

Syneos Health
United Kingdom
First published:
06/03/2024
InstitutionNon-Pharmaceutical companyENCePP partner

Contact details

Anita Verga

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Allergan
Study protocol
Initial protocol

191622-140 Protocol v2013-05-06 (002).REDACTED

English (388.22 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only