OBJECTIVE: To develop an instrument to assess male patient's and their female partner's satisfaction with the treatment for erectile dysfunction (ED) and assess the comprehensiveness, comprehension, acceptability and clarity of the instrument. METHODS: Four phases were performed in the questionnaire development; item generation, face and content validity, cognitive debriefing, cultural and language adaptation. Item generation was based on literature review, hypothesized characteristics of the drug and in-depth interviews with patients and their partners. Perceptions and feelings related to the condition and their expectations of treatment were examined. Items were generated simultaneously in English, French and German and adapted to each culture. Content and face validity were assessed by interviews with patients and partners in 5 countries. Testing of structure and response scales, cognitive debriefing and verification of conceptual equivalence between languages was assessed. RESULTS: A total of 55 interviews were conducted to test face and content validity for patients, partners and experts. The final content areas deemed important included spontaneity, quality of erection, quality of ejaculation, sexual pleasure, satisfaction with orgasm, confidence, reliability of treatment, side effect, convenience, overall satisfaction, conformity to treatment expectations and intentions for continued use of drug. Cognitive debriefing with patients and partners found no problems with comprehension. Results of the debriefing found some words to be problematic. There were no cultural differences found between the English, French or German version. The questionnaire was revised at each phase. The final questionnaire for both the patient and the partner contained 19 questions. The questionnaire was then translated into 14 additional languages for use in clinical trials. CONCLUSIONS: The TSS is a comprehensive measure of male ED patients and their respective partners. Further work is needed to validate the TSS, identify the domains, test the responsiveness and determine the appropriate scoring.