Evaluation of the Safety and Effectiveness of BOTOX® (Clostridium Botulinum Toxin Type A) in the Treatment of Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder: A Post-marketing Surveillance Study inKorea

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34187
• EU PAS number:
  EUPAS16140
• Study ID:
  34187
• Official title and acronym:
  Evaluation of the Safety and Effectiveness of BOTOX® (Clostridium Botulinum Toxin Type A) in the Treatment of Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder: A Post-marketing Surveillance Study inKorea
• DARWIN EU® study:
  No
• Study countries:
  Korea, Democratic People's Republic of
• Study description:
  Study Objectives The purpose of this PMS 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 Korea. Study Population Adult patients (≥ 18 years of age) with urinary incontinence due to NDO, e.g. as a result of SCI or MS, or with symptoms of urge urinary incontinence, urgency, and frequency 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 This study will be mainly conducted by collecting relevant information on treated patients from contracted specialists in the applicable hospitals/clinics. Patient Recruitment The investigators will continuously enroll all eligible patients treated with BOTOX at the relevant hospital(s) to ensure unbiased enrollment of patients during the agreed surveillance period. Study Size Allergan plans to study approximately 600 patients with NDO or OAB who have received BOTOX injection(s) for the treatment of urinary incontinence and other symptoms. 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. The ICIQ-SF will be administered to patients before the injection of BOTOX and at the next office visit within 1 to 4 months after injection of BOTOX. The evaluation will be based on the change in the total score before and after administration of the BOTOX (ICIQ Score change = post-injection ICIQ score – pre-injection ICIQ score). Duration The study should be completed within 4 years after approval Analysis The analyses will be descriptive in nature.
• Study status:
  Finalised

Research institutions and networks

Institutions

DreamCIS

Study timelines

Date when funding contract was signed

Actual: 24/09/2013

Study start date

Planned: 30/01/2014

Actual: 05/02/2014

Date of final study report

Planned: 30/12/2016

Actual: 30/11/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Allergan

Study protocol

Initial protocol

(Korea) Botox in NDO NOV2013

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only