Role of composite endpoints as an outcome assessment tool in urogenital prolapse

Abstract

Our aim was to assess the role of composite endpoints as outcome assessment tools in urogenital prolapse. Women undergoing surgery for urogenital prolapse were recruited and followed-up over 1 year. ‘Cure’ following surgery was defined as: (1) Objective: POP-Q ordinal = 0 (pelvic organ prolapse quantification system); (2) Subjective: PGI-I = 1 or 2 (patient global impression of improvement); (3) Composite endpoint of cure: POP-Q ordinal = zero and patient goal achievement = 60%. Our results showed ‘Composite cure’ of POP was in 88.7%, while objective and subjective cure were 85.3% and 95.5%, respectively. Defining ‘success’ or ‘failures’ based on PGI-I scores was most discriminatory. Quality of life (QoL) was similar in treatment success or failure groups, where cure was measured objectively or using the composite endpoint. Composite endpoints should accurately represent cure as they combine objective measures and patient goals. However, these were not demonstrated as valid methods in defining success of prolapse surgery.

Keywords::

• Composite endpoints
• surgical cure
• urogenital prolapse
• subjective cure
• objective cure

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.