To date, separate condition-specific instruments have been used to assess severity of symptoms, in men and women with urological pain conditions. We developed a single instrument that can be used to assess treatment response in clinical trials and cohort studies that involve both genders.
Methods
We developed the Genitourinary Pain Index (GUPI) by modifying and adding questions to the National Institutes of Health-Chronic Prostatitis Symptom Index. To assess discriminant validity, concurrent validity, and reliability, we administered the GUPI to 1653 men and 1403 women in a large managed care population. To assess responsiveness, we administered the GUPI to 47 men and women who completed a National Institutes of Health-sponsored trial of pelvic floor physical therapy.
Results
The GUPI discriminated between men with chronic prostatitis or interstitial cystitis, those with other symptomatic conditions (dysuria, frequency, chronic cystitis), and those with none of these diagnoses (P <.05). It also discriminated between women with interstitial cystitis, those with incontinence, and those with none of these diagnoses (P <.05). The GUPI demonstrated good internal consistency within subscale domains, and GUPI scores correlated highly with scores on the Interstitial Cystitis Symptom Index and Problem Index. The GUPI was highly responsive to change, and the change in score was similar in both male and female responders. A reduction of 7 points robustly predicted being a treatment responder (sensitivity 100%, specificity 76%).
Conclusions
The GUPI is a valid, reliable, and responsive instrument that can be used to assess the degree of symptoms in both men and women with genitourinary pain complaints.
aDepartment of Urology, University of Michigan Medical Center, Ann Arbor, Michigan
bDepartment of Health Policy and Administration, University of Illinois at Chicago School of Public Health, Chicago, IL
cDepartment of Urology, UCLA School of Medicine and Public Health, Los Angeles, CA
dDepartment of Medicine, Harvard Medical School, Boston, MA
eNational Institute of Diabetes, Digestive and Kidney Diseases, Bethesda, MD
fCenter for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA
Reprint requests: J. Quentin Clemens, M.D., M.S.C.I., Department of Urology, University of Michigan Medical Center, 1500 E Medical Center Drive, Taubman Center 3875, Ann Arbor, MI 48109-5330
This study was supported by grant number NIDDK 5U01DK065257.