Neurourology and Urodynamics Development and Validation of the Pelvic Floor Inventories Leiden (PelFIs) Petra J. Voorham-van der Zalm, 1 * Anne M. Stiggelbout, 2 Ilona Aardoom, 1 Stella Deckers, 1 Inge G. Greve, 1 Guus A.B. Lycklama a ` Nijeholt, 1 and Rob C.M. Pelger 1 1 Department of Urology, Leiden University Medical Center, Leiden, The Netherlands 2 Department of Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands Aims: To evaluate the validity and reliability in Dutch of the Pelvic Floor Inventories Leiden (PelFIs) for men and women, an administered questionnaire, developed to create a condition-specific pelvic floor questionnaire addressing all symptoms of micturition, defecation and sexual dysfunction related to pelvic floor dysfunction. Methods: The PelFIs is an 83-item instrument for women and 76-item instrument for men measuring the degree of pelvic floor dysfunction, containing nine different domains. Questions have been selected which, from a clinical point of view, should configure a domain. The PelFIs was administered to healthy volunteers (N ¼ 120), and to patients (N ¼ 100). Reliability of the PelFIs was assessed by internal consistency and test-retest reliability. Construct validity was established comparing healthy volunteers and patients by intercorrelating the domains. Results: A total of 220 questionnaires were completed; by 147 women and 73 men. Some domains in the men’s questionnaire had a low alpha (a) although the overall a was good. The overall of the domains for men ranged from 0.53 to 0.90. The internal consistency for the total scale of men’s questionnaire was 0.84. The overall of the domains in women ranged from 0.60 to 0.85. The internal consistency of the women’s questionnaire was 0.88 for the total scale. Intraclass correlation ranged from 0.65 to 0.88. Differences between healthy volunteers and patients were statistically significant for all domains. Conclusion: The PelFIs is a new, practical and conceptually clear questionnaire, which focus on micturition, defecation and/or sexual dysfunction related to pelvic floor dysfunction. Neurourol. Urodynam. ß 2007 Wiley-Liss, Inc. Key words: pelvic floor; questionnaire; validation INTRODUCTION The pelvic floor controls individual and integrated func- tions, sustains proper anatomic relationships between pelvic visceral organs and their outlets, and shares the basic mechanism with various visceral organs whose functions it controls. The pelvic floor is the binding element between these organs. Lower urinary tract, lower gastrointestinal and sexual dysfunctions are due to pelvic floor dysfunction. 1 Literature is scarce on the topic of pelvic floor investigation and treatment. Assessment of the function of the pelvic floor muscles, as in muscle strength, tone, endurance and coordination, is not easy, due to a lack of simple to use and reliable measurement techniques, and a lack of cut-off values for pathological conditions. Furthermore, the reproducibility of testing is questionable. Research on this topic is important, because many people suffer from the consequences of pelvic floor dysfunction such as loss of urinary control. Pelvic floor dysfunction affects the social, psychological, domestic, occupational, physical and sexual lives of 15–30% of women of all ages. 2 Despite the fact that urinary incontinence can lead to a social handicap, only 28% of women and men seek help for their symptoms. The main reason for not seeking help is the fact that the complaints are not considered to be serious enough by the patients and many health professionals. 3 During the diagnostic process a complete medical and injury history should be documented. 4,5 A number of standardized questionnaires are available, for example, the Pelvic Floor Distress Inventory (PFDI), the Pelvic Floor Impact Questionnaire (PFIQ), 6 the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) 7 and the King’s Health Questionnaire (KHQ). 8,9 These questionnaires assess parts of pelvic floor dysfunction and/or quality of life, have been developed for specialists in Urology and Gynaecology and are not focused on pelvic floor dysfunction in a broad sense related to micturition, defecation and/or sexual dysfunction. Only the recently published Electronic Pelvic Floor Assessment Questionnaire (e-PAQ) assesses all aspects of pelvic floor dysfunction. 10 Our department has developed a new administered ques- tionnaire, the Pelvic Floor Inventories Leiden (PelFIs) for men and women in Dutch, in an attempt to create a new condition- specific pelvic floor questionnaire addressing all symptoms of micturition, defecation and sexual dysfunction related to pelvic floor dysfunction for use by professionals active in this field. The PelFIs questionnaire has also been developed in an attempt to create more uniformity in history taking in patients with symptoms of pelvic floor dysfunction and thus increasing quality of care. METHODS Questionnaire The inventory items were identified from a comprehensive literature review, and form 9 different domains: (1) symptoms of prolapse (1 in men, 4 in women), (2) Micturition pattern (13 in both men and women), (3) urinary incontinence No conflict of interest reported by the author(s). Christopher Chapple led the review process. *Correspondence to: Petra J. Voorham-van der Zalm, Department of Urology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands. E-mail: pjvoorham@lumc.nl Received 14 June 2007; Accepted 16 August 2007 Published online in Wiley InterScience (www.interscience.wiley.com) DOI 10.1002/nau.20514 ß 2007 Wiley-Liss, Inc.