Purpose: For most patients, leakages related to Stress Urinary Incontinence (SUI) are the consequence of usual efforts in activities of daily life increasing abdominal pressure. There is a need for highly specific and sensitive endpoints to evaluate specific effects of treatment in SUI clinical trials since incontinence episode frequency (IEF) is obviously highly related to maintenance or avoidance of causal activities. Our aim was to develop a patient-reported outcome instrument describing how patients adapt to keep control of risk of leakage in daily life

Methods: Efforts which provoke leakage were listed from a systematic review of published studies and 30 clinicians interviews. Eight clinicians covering the various medical specialities involved in the care of SUI were interviewed, following a semi-structured interview guide, to: 1) comment the list in terms of relevance, comprehensiveness, and sensitivity; 2) report how their patients manage to better control the risk of leakage and 3) select the efforts that were most frequently spontaneously mentioned by their patients. A draft scale was then developed. Twenty SUI women were asked to 1) assess the relevance, importance, and applicability of each effort and 2) reword the descriptions of efforts and how they control the risk of leakage. The scale was then updated according to their comments.

Results: Fifteen UI specific scales and 21 studies were selected from the literature, reviewed and analysed. A list of 72 efforts of daily life which provoke leakage was set up. Interviews with the clinicians allowed to identified redundancies, to group similar concepts and to set up a short list containing the 15 most relevant efforts. The answer choices cover the occurrence of leakage, and various behaviour adaptation such as seeking help, taking precautions, using muscular control, and avoiding situations. After validation of format, items, wording, and answer choice, by the patients, the pilot scale was produced.

Conclusions: This self-reported scale allows SUI patients to accurately describe their control on leakage risk in efforts of daily life. This highly specific instrument will allow clinicians to better assess the true impact of therapeutics on the patients' life. The scoring procedure and its properties will be assessed in a specific validation study.