OBJECTIVES: The Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12), a condition-specific self-rating questionnaire, comprises 12 items investigating sexual functionality in women with pelvic organ prolapse (POP) or urinary incontinence (UI). The scale investigates behavioural emotive, physical and partner-related factors. This paper reports on the Italian validation of the PISQ-12. METHODS: The linguistic validation of the scale consisted of forward and backward translation. It was performed through a multi-step process, which involved two Italian mother-tongue professionals and a native English speaker co-working with clinical investigators. This version was pre-tested on a set of 49 women, who were interviewed after filling-in the questionnaire and a comprehension rate was built as the percentage of correctly understood questions and pre-coded answers. A case-control study was performed. Sexually active women aged >= 18 year and affected by UI/POP for at least 3 months and with negative dipstick were consecutively enrolled as cases. Controls were defined as healthy women of comparable age. In order to evaluate reliability, cases were retested after 7-21 days from baseline and a correlation analysis was performed. RESULTS: For 10 out of 12 items >90% patients found the Italian version easy to understand. Nine patients reported they could not understand the first item: How frequently do you feel sexual desire? This feeling may include wanting to have sex, planning to have sex, feeling frustrated due to lack of sex; 42% of patients did not interpret frustration as delusion. This item was also differently translated during the forward translation and discussed. Five patients did not correctly understand Item 4: How satisfied are you with the variety of sexual activities in you current sex life?, as regards the word variety. CONCLUSION: The PISQ-12 proved to be easy to understand and suitable for clinical research and routine. The evaluation of psychometric properties is on-going.