title: Use of Concomitant Stress Incontinence Surgery at Time of Pelvic Organ Prolapse Surgery Since Release of the 2011 Notification on Serious Complications Associated with Transvaginal Mesh.
abstract: There is controversy regarding the performance of concomitant anti-incontinence procedures at the time of pelvic organ prolapse repair. Data support improvement in stress urinary incontinence with a concomitant sling but increased adverse events. We assessed trends in preoperative stress urinary incontinence evaluation, concomitant anti-incontinence procedure at pelvic organ prolapse surgery and postoperative anti-incontinence procedures at our institution before and after the 2011 FDA (U.S. Food and Drug Administration) Public Health Notification pertaining to vaginal mesh.
  
  
  
  We retrospectively reviewed the records of patients who underwent pelvic organ prolapse surgery from 2009 to 2015. Preoperative workup included assessment of subjective stress urinary incontinence and/or evaluation for leakage with reduction of pelvic organ prolapse on physical examination, urodynamics or a pessary trial. The percentages of concomitant and postoperative anti-incontinence procedures were compared before and after the 2011 FDA notification.
  
  
  
  A total of 775 women underwent pelvic organ prolapse repair. The percentage of anti-incontinence procedures at pelvic organ prolapse repair decreased from 54.8% to 38.0% after the FDA notification (p = 0.002) while the incidence of preoperative objective stress urinary incontinence on examination, urodynamics and pessary trials remained constant. The incidence of postoperative anti-incontinence procedures within 1 year of the index surgery remained low.
  
  
  
  We found a decrease in the incidence of concomitant anti-incontinence procedures at the time of pelvic organ prolapse repair following the 2011 FDA notification despite no significant decline in subjective stress urinary incontinence or demonstrable stress urinary incontinence on preoperative evaluation. Further analysis is warranted to assess the impact of the FDA notification on treatment patterns in women with pelvic organ prolapse and stress urinary incontinence.
authors.affiliation: New York University Langone Medical Center, New York, New York. Electronic address: alice.drain@nyumc.org.
authors.forename: Alice
authors.initials: A
authors.lastname: Drain
authors.affiliation: New York University Langone Medical Center, New York, New York.
authors.forename: Aqsa
authors.initials: A
authors.lastname: Khan
authors.affiliation: New York University Langone Medical Center, New York, New York.
authors.forename: Erin L
authors.initials: EL
authors.lastname: Ohmann
authors.affiliation: New York University Langone Medical Center, New York, New York.
authors.forename: Benjamin M
authors.initials: BM
authors.lastname: Brucker
authors.affiliation: New York University Langone Medical Center, New York, New York.
authors.forename: Scott
authors.initials: S
authors.lastname: Smilen
authors.affiliation: New York University Langone Medical Center, New York, New York.
authors.forename: Nirit
authors.initials: N
authors.lastname: Rosenblum
authors.affiliation: New York University Langone Medical Center, New York, New York.
authors.forename: Victor W
authors.initials: VW
authors.lastname: Nitti
mesh_terms: D005260:Female; D006801:Humans; D008875:Middle Aged; D056887:Pelvic Organ Prolapse / Q000150:complications / Q000601:surgery*; D011183:Postoperative Complications / Q000209:etiology; D000078337:Procedures and Techniques Utilization / Q000706:statistics & numerical data; D012189:Retrospective Studies; D013526:Surgical Mesh / Q000009:adverse effects; D014550:Urinary Incontinence, Stress / Q000150:complications / Q000601:surgery*; D013520:Urologic Surgical Procedures / Q000379:methods
keywords: decision making; pelvic organ prolapse; stress; suburethral slings; urethra; urinary incontinence