title: Safety and effectiveness of Colpexin Sphere in the treatment of pelvic organ prolapse.
abstract: Our objective was to determine the safety and effectiveness of Colpexin Sphere in women with advanced genital prolapse. A total of 39 subjects were enrolled in our prospective multicenter clinical trial, and 27 completed the full 16-week assessment. At baseline, subjects were fitted with a sphere, instructed on insertion and removal, and educated on a regimen of pelvic floor muscle exercises performed with the device in place. Efficacy was evaluated by a baseline vs 16-week comparison of pelvic organ prolapse staging and pelvic floor muscle strength assessment. Safety evaluation included, but was not limited to, an assessment of vaginal mucosal integrity. Subjects also completed a patient satisfaction questionnaire at the end of the study. Improvement in the prolapse of at least one vaginal segment was seen in 81.5% of the subjects, while 63% exhibited improved muscle function on digital examination at 16 weeks. Twenty-five (92.6%) would recommend the device to treat prolapse, and most found it easy to insert (96.3%) and remove (100%). In short-term usage, problems with urination (29.6%) and defecation (72%) were reported, primarily due to device displacement. Two subjects developed superficial vaginal mucosal ulceration, which resolved spontaneously. No significant adverse events were reported.
authors.affiliation: Urogynecology Associates of Colorado, Denver, CO, USA.
authors.forename: James Chivian
authors.initials: JC
authors.lastname: Lukban
authors.forename: Oscar A
authors.initials: OA
authors.lastname: Aguirre
authors.forename: G Willy
authors.initials: GW
authors.lastname: Davila
authors.forename: Peter K
authors.initials: PK
authors.lastname: Sand
mesh_terms: D000328:Adult; D000368:Aged; D003710:Demography; D004869:Equipment Safety; D005260:Female; D006801:Humans; D007434:Intrauterine Devices; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D053580:Muscle Strength / Q000502:physiology; D017773:Pelvic Floor / Q000000981:diagnostic imaging / Q000473:pathology* / Q000502:physiology / Q000503:physiopathology; D011391:Prolapse; D011859:Radiography; D011795:Surveys and Questionnaires