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The primary objective of this pilot study is to evaluate the safety and effectiveness of the VFIX device in maintaining vaginal apical support for at least 6 months in women with symptomatic apical prolapse (upper vaginal or uterine prolapse).
Assuming success of the VFIX anatomical observational study (protocol 300-08-009), in this pilot study approximately 20 subjects (excluding the Device Run-In (DRI) subjects) will undergo the VFIX procedure to evaluate the safety and effectiveness of the VFIX device in maintaining apical support for at least 6 months, in women with symptomatic apical prolapse.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pelvic Organ Prolapse
Published on BioPortfolio: 2014-07-23T21:09:25-0400
The purpose of this pilot study is to perform a procedure to evaluate the safety of the placement of a new device (known as the VFIX device).
The purpose of this study is to compare the effectiveness of R-SCP versus HUSLS for treatment of pelvic organ prolapse.
This study is a 1 year review of all patients who had surgery to correct pelvic organ prolapse (i.e. cystocele, rectocele, enterocele) using the Avaulta synthetic mesh kit.
This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial is des...
This is a retrospective descriptive study using the American College of Surgeon's National Surgical Quality Improvement Program® (ACS NSQIP®) data to determine whether gynecologic surgeo...
Pelvic organ prolapse is a common problem among geriatric women. Advanced age is associated with a high prevalence of comorbidities that can lead to restrictive use of surgical treatment. With rising ...
Pelvic organ prolapse is prevalent among women with rectal prolapse.
The objective of this study was to determine if weight loss surgery is associated with decreased prevalence of urinary incontinence (UI) and pelvic organ prolapse (POP) symptoms.
In pelvic organ prolapse, the anatomical defects develop at the anterior (anterior vaginal wall), the posterior (posterior vaginal wall) and the apical (the uterus/cervix or the apex of the vagina, va...
Women have an estimated 12.6% lifetime risk of undergoing surgery for pelvic organ prolapse in the USA (Wu et al. in Obstet Gynecol 123(6): 1201-6, 2014). Surgical repair of uterovaginal prolapse most...
Abnormal descent of a pelvic organ resulting in the protrusion of the organ beyond its normal anatomical confines. Symptoms often include vaginal discomfort, DYSPAREUNIA; URINARY STRESS INCONTINENCE; and FECAL INCONTINENCE.
Injury, weakening, or PROLAPSE of the pelvic muscles, surrounding connective tissues or ligaments (PELVIC FLOOR).
Soft tissue formed mainly by the pelvic diaphragm, which is composed of the two levator ani and two coccygeus muscles. The pelvic diaphragm lies just below the pelvic aperture (outlet) and separates the pelvic cavity from the PERINEUM. It extends between the PUBIC BONE anteriorly and the COCCYX posteriorly.
The prolapse or downward displacement of the VISCERA.
The part of the pelvis, inferior to the pelvic brim, that comprises both the pelvic cavity and the part of the PERINEUM lying inferior to the PELVIC DIAPHRAGM.
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