Papers by Edward Stanford
Journal of Minimally Invasive Gynecology, 2012
Neurourology and Urodynamics, 2011
Study design, materials and methods One hundred and forty-two women were enrolled at 16 investiga... more Study design, materials and methods One hundred and forty-two women were enrolled at 16 investigational sites (10 U.S., 6 E.U.) of which 125 (88.0%) completed 12-months follow-up. Of the 17 subjects who did not complete the 12-months visit, 8 missed the visit; 4 were lost to follow up; 3 voluntarily withdrew consent; 1 had device removed and 1 died (unrelated to procedure). The primary outcome was treatment failure defined as > Stage II POP-Q anytime during follow-up using the Last Failure Carried Forward (LFCF) method. The LFCF method carries forward a patients’ objective failure at 6 months if their 12 month results were missing. And it also considers subjects to be failures if they were re-operated for recurrent prolapse in the anterior or apical segments within 12 months from the initial implant, regardless of their 6 month and 12 month test results. Subjects who had a concomitant Elevate Apical and Posterior system were excluded from the apical efficacy analysis. Secondary o...
Journal of minimally invasive gynecology
To assess the outcomes and complications of transvaginally placed custom-shaped light-weight poly... more To assess the outcomes and complications of transvaginally placed custom-shaped light-weight polypropylene mesh for repair of pelvic organ prolapse.
Journal of Minimally Invasive Gynecology, 2008
The study objective was to review the existing literature regarding complications of anti-inconti... more The study objective was to review the existing literature regarding complications of anti-incontinence sling procedures. PubMed listings using keywords related to slings and associated complications with no date or language restrictions through May 2007 and the Manufacturer and User Facility Device Experience Database were searched for specific device-and procedure-related complications. Where no information was available, published abstracts were cited. Published reports of complications for all types of anti-incontinence sling procedures are analyzed and reported. Sling-related complications are multiple but can be summarized from studies on 13 737 cumulative patients as involving: voiding dysfunction (8 studies, 881 patients, 16.3% average overall incidence [OI]); detrusor overactivity (20 studies, 1950 patients, 15.4% OI); urinary retention (14 studies, 943 patients, 14.2% OI); erosion/extrusion (19 studies, 2197 patients, 6.03% OI); impact on quality of life-dyspareunia (2 studies, 175 patients, 4.3% OI); infections-most often urinary tract infections but severe infections such as abscess are reported (19 studies, 1487 patients, 5.5% OI); hematoma-most often pelvic or vaginal (4 studies, 3691 patients, 2% OI); pain (6 studies, 597 patients, 7.3% OI); abdominal and pelvic organ injury-bladder, urethra, vagina, and intestines (10 studies, 1816 patients, 3.3% OI); systemic complications-deep vein thrombosis, sepsis (case reports); and death (case reports). Cure rates for all slings are as follows: subjective (16 studies, 1541 patients, 95% OI, range 63%-99%), objective (15 studies, 1203 patients, 82% OI, range 51%-97%), and failure (8 studies, 599 patients, 11.5% OI, range 4%-37%). It is likely that sling-related complications are under-reported in the published medical literature and in the Manufacturer and User Facility Device Experience Database. This review reports on the incidence of known complications for all types of slings. Some complications are common to all sling techniques; however, with development of minimally invasive slings, device-related complications are reported and compared.
International Urogynecology Journal, 2007
Journal of Minimally Invasive Gynecology, 2008
The study objective was to review the existing literature regarding complications of anti-inconti... more The study objective was to review the existing literature regarding complications of anti-incontinence sling procedures. PubMed listings using keywords related to slings and associated complications with no date or language restrictions through May 2007 and the Manufacturer and User Facility Device Experience Database were searched for specific device-and procedure-related complications. Where no information was available, published abstracts were cited. Published reports of complications for all types of anti-incontinence sling procedures are analyzed and reported. Sling-related complications are multiple but can be summarized from studies on 13 737 cumulative patients as involving: voiding dysfunction (8 studies, 881 patients, 16.3% average overall incidence [OI]); detrusor overactivity (20 studies, 1950 patients, 15.4% OI); urinary retention (14 studies, 943 patients, 14.2% OI); erosion/extrusion (19 studies, 2197 patients, 6.03% OI); impact on quality of life-dyspareunia (2 studies, 175 patients, 4.3% OI); infections-most often urinary tract infections but severe infections such as abscess are reported (19 studies, 1487 patients, 5.5% OI); hematoma-most often pelvic or vaginal (4 studies, 3691 patients, 2% OI); pain (6 studies, 597 patients, 7.3% OI); abdominal and pelvic organ injury-bladder, urethra, vagina, and intestines (10 studies, 1816 patients, 3.3% OI); systemic complications-deep vein thrombosis, sepsis (case reports); and death (case reports). Cure rates for all slings are as follows: subjective (16 studies, 1541 patients, 95% OI, range 63%-99%), objective (15 studies, 1203 patients, 82% OI, range 51%-97%), and failure (8 studies, 599 patients, 11.5% OI, range 4%-37%). It is likely that sling-related complications are under-reported in the published medical literature and in the Manufacturer and User Facility Device Experience Database. This review reports on the incidence of known complications for all types of slings. Some complications are common to all sling techniques; however, with development of minimally invasive slings, device-related complications are reported and compared.
American Journal of Obstetrics and Gynecology, 2010
on behalf of the Urogynecology Network OBJECTIVE: The objective of the study was to evaluate the ... more on behalf of the Urogynecology Network OBJECTIVE: The objective of the study was to evaluate the use of urodynamics to determine the need for incontinence surgery at the time of abdominal sacrocolpopexy (ASC). STUDY DESIGN: The records of 441 women undergoing ASC during 2005-2007 were reviewed. Group 1 consisted of 204 women (46.3%) with urodynamic stress incontinence (USI), including occult USI, who underwent incontinence surgery with ASC. Group 2 consisted of 237 women (53.7%) without USI who underwent ASC alone. Primary outcome measures were any complaint of postoperative incontinence (stress or urge) or new-onset urgency/frequency (UF).
American Journal of Obstetrics and Gynecology, 2006
International Urogynecology Journal, 2004
The abdominal sacrocolpopexy is an excellent procedure to surgically treat vaginal vault prolapse... more The abdominal sacrocolpopexy is an excellent procedure to surgically treat vaginal vault prolapse. A synthetic graft is often used to support the vaginal apex, but has the potential to become infected or erode, requiring its removal or revision. The purpose of this paper is to report our experience in the management of patients with infected synthetic grafts after abdominal sacrocolpopexy. A review of the patient databases from three specialty gynecology centers was performed from March 1996 to June 2002. Only patients with an infected graft after an abdominal sacrocolpopexy were included in the study; patients with either suture or graft erosion responding to conservative treatment were excluded. Twenty-two women, ages 37–73 years, developed infection of the synthetic graft after an abdominal sacrocolpopexy (1–60 months after their initial surgery, mean 8.8 months). The infected materials included polytetrafluoroethylene (PTFE, Goretex, n =15) and polypropylene ( n =7). Nine of the 15 PTFE meshes and four of the seven polypropylene meshes were placed at the time of a contaminated case (abdominal hysterectomy [ n =12], colon resection [ n =1]). Eighteen (82%) of the infected grafts involved braided permanent suture to attach the graft to the vaginal wall, monofilament/non-braided permanent suture was used in three patients, and suture type could not be determined in one. All graft removals were attempted vaginally, and this was successful in 16 cases (73%). Two patients experienced significant bleeding: the first patient required an emergency laparotomy and the second patient’s bleeding was controlled with packing. A rectovaginal fistula occurred 3 weeks postoperatively in one patient. Synthetic graft infection should be considered as the differential diagnosis in a patient who has undergone an abdominal sacrocolpopexy. Transvaginal removal is preferred, but is fraught with potentially serious complications. The use of braided permanent sutures to affix the graft to the vagina may be associated with mesh infections.
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Papers by Edward Stanford