An observational study in Pelvic Floor Disorders, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-11-11.
Sponsored by University of California, San Diego · Observational
The specific aim of this study is to evaluate the effect of surgically-induced weight reduction, as achieved by laparoscopic gastric banding or sleeve gastrectomy, on pelvic floor disorders such as stress urinary incontinence, overactive bladder, anal incontinence, and pelvic organ prolapse in severely, morbidly and super-obese women using a prospective, observational study design.
197 studies on the registry are indexed under Pelvic Floor Disorders; 45 are open to participants now.
This study's planned enrollment of 100 is below the median of 140 across 58 observational studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
100 obese women who have met surgical eligibility for laparoscopic adjustable gastric banding at the Center for the Treatment of Obesity at UCSD
Exclusion Criteria:
100 obese women undergoing laparoscopic adjustable gastric banding
Procedure: LapBand
Prospective observation study of 100 obese women undergoing laparoscopic gastric banding to determine impact of weight loss on pelvic floor disorders
Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire
Time frame: 12 months
Weekly incontinence episodes and pad use ascertained by incontinence diary
Time frame: 12 months
Quality of life impact ascertained by validated measures (PFIQ, PFDI, FISI, and PGI-I)
Time frame: 12 months
Sexual function ascertained by validated measure (PISQ)
Time frame: 12 months
This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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University of California, San Diego