Barbed-suture Efficiency Study for Sacrocolpopexy (BEST)
Prolapse; Female
About this trial
This is an interventional treatment trial for Prolapse; Female focused on measuring sacrocolpopexy, pelvic organ prolapse, vaginal mesh attachment
Eligibility Criteria
Inclusion Criteria: Age ≥21 Subject must have apical with anterior or posterior vaginal prolapse with leading edge of prolapse to or beyond the hymen Subject reports a bothersome bulge they can see or feel per Pelvic Floor Disability Index (PFDI-20), question 3, response of 2 or higher Eligible for laparoscopic or robotic sacrocolpopexy Desires surgical treatment for symptomatic uterovaginal or vaginal vault prolapse English speaking Exclusion Criteria: Patients who are not surgical candidates due to medical comorbidities Current foreign body complications (including but not limited to erosion, fistula, abscess). This covers foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft). Inability to give informed consent or to complete the testing or data collection. Anticipated circumstances resulting in an inability to follow up (geographic relocation, etc.). Active systemic infection including any gynecologic infection, untreated Urinary Tract Infection (UTI) or tissue necrosis. History of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical). Prior or currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area. Subject has taken systemic steroids (within the last month, steroid inhalers OK), or immunosuppressive or immunomodulatory treatment (within the last 3 months) Systemic connective tissue disease (e.g. scleroderma, Marfan's syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatic, lupus) Chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis Poorly controlled diabetes mellitus (DM), as indicated by Hemoglobin A1c > 9 Those requiring concomitant rectopexy Subject is not able to conform to steep Trendelenburg position Known sensitivity to polypropylene History of prior prolapse repair utilizing vaginal or abdominal mesh Planned vaginal mesh attachment placed transvaginally History of diverticulitis
Sites / Locations
- Wake Forest University Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Non-barbed delayed absorbable suture
Barbed delayed absorbable suture
Participants assigned to Non-barbed delayed absorbable suture group will have Non-barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP
Participants assigned to Barbed delayed absorbable suture group will have Barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP