Stress Urinary Incontinence and Suicidality Seen in the United Kingdom General Practice Research Database (F1J-MC-B056)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/21190
• EU PAS number:
  EUPAS20247
• Study ID:
  21190
• Official title and acronym:
  Stress Urinary Incontinence and Suicidality Seen in the United Kingdom General Practice Research Database (F1J-MC-B056)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study investigated the association between stress urinary incontinence (SUI) and suicidality:Primary Objective: To assess the association between suicide attempts (both non-fatal and completed) and receipt of duloxetine treatment in women with SUI compared to SUI women without duloxetine treatment, accounting for important demographic and medical history covariates.Secondary Objective: To study the association between suicidal ideation and duloxetine by comparing women with SUI who received duloxetine and women with SUI who did not receive duloxetine, accounting for important demographic and medical history covariates.Exploratory Objectives: To evaluate the association between suicidality-related outcomes and SUI case status or not, accounting for important demographic and medical history covariates.
• Study status:
  Finalised

Research institutions and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Planned: 11/11/2015

Actual: 11/11/2015

Study start date

Planned: 01/12/2017

Actual: 27/01/2016

Data analysis start date

Planned: 01/10/2016

Actual: 12/05/2017

Date of final study report

Planned: 31/03/2017

Actual: 01/09/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)