Outcomes of pelvic floor dysfunction (PFD) treatments remain poorly measured, precluding scientific conclusions about their effectiveness. Currently available surgical and non-surgical therapies for these common conditions have not been rigorously scrutinized with regard to subsequent impact on individual quality-of-life [QOL] or morbidity reduction. Although patient subjective opinions concerning surgical results are important, they are subject to interpretative difficulties. Several PFD-specific QOL scales have been developed and validated. These measures, however, do not assess the specific treatment goals of individual patients, and therefore, are limited when incorporating patient-centered goals into therapy. This prospective cohort study will classify and compare patient subjective goals and outcomes with respect to treatment interventions for disorders of the female pelvic floor. Preliminary investigation indicates an ample patient base for recruiting participants, and feasibility of recruitment and follow-up. We will enroll and follow 405 patients with PFD, expecting 270 in the conservative management arm and 135 in the surgical management arm. The primary outcome will be self-reported achievement of patient-derived goals. Data will be collected from patient interviews, questionnaires, physical examination, and laboratory testing. Patient-derived goals will be defined at baseline and followed over 12 months to determine the degree to which patient-derived goals are reported to have been met. Goal achievement among surgical patients will be compared to that among non-surgically managed patients. The study will provide the first estimates of goals and goal attainment in PFD, and determine whether goal attainment in surgically and non-surgically managed PFD is likely to differ. In addition, objective outcome measures and established QOL instruments will be compared and contrasted with the perception of goal achievement. While QOL measures allow consistent assessment of general PFD outcomes, assessing patient-centered goals allows individually tailored care of women with pelvic floor dysfunction. Patient goals, combined with clinical and QOL measures, may be used to provide comprehensive, multidisciplinary, patient-centered approaches to prevention, management, treatment, and rehabilitation. ? ?

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Research Grants (R03)
Project #
5R03HD042754-02
Application #
6795584
Study Section
Special Emphasis Panel (ZHD1-DRG-D (HK))
Program Officer
Parrott, Estella C
Project Start
2003-09-01
Project End
2006-12-31
Budget Start
2004-09-01
Budget End
2006-12-31
Support Year
2
Fiscal Year
2004
Total Cost
$76,042
Indirect Cost
Name
University of Virginia
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
065391526
City
Charlottesville
State
VA
Country
United States
Zip Code
22904
Bovbjerg, Viktor E; Trowbridge, Elisa R; Barber, Matthew D et al. (2009) Patient-centered treatment goals for pelvic floor disorders: association with quality-of-life and patient satisfaction. Am J Obstet Gynecol 200:568.e1-6
Hullfish, Kathie L; Bovbjerg, Viktor E; Gurka, Matthew J et al. (2008) Surgical versus nonsurgical treatment of women with pelvic floor dysfunction: patient centered goals at 1 year. J Urol 179:2280-5;discussion 2285
Hullfish, K L; Bovbjerg, V E; Steers, W D (2007) Colpocleisis for pelvic organ prolapse: patient goals, quality of life, and satisfaction. Obstet Gynecol 110:341-5
Pastore, Lisa M; Kightlinger, Rebecca S; Hullfish, Kathie (2007) Vaginal symptoms and urinary incontinence in the elderly women. Geriatrics 62:12-8