Safety and effectiveness of Colpexin Sphere in the treatment of pelvic organ prolapse.
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.
Lukban
James Chivian
JC
Urogynecology Associates of Colorado, Denver, CO, USA.
Aguirre
Oscar A
OA
Davila
G Willy
GW
Sand
Peter K
PK
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