This is an extension study of a prospective, multicenter, randomized, single-blind trial whose purpose is to compare mesh-related complications and effectiveness of pelvic organ prolapse (POP) repair in women undergoing minimally-invasive total hysterectomy and sacrocolpopexy (SCP) with a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent (polytetrafluoroethylene, Gore-Tex) versus delayed absorbable monofilament (polydioxanone, PDS) suture for vaginal mesh attachment through at least 3 years after surgery.
This is an extension study of a randomized controlled trial that will be conducted at the same 5 clinical sites as the primary study - All subjects who participated in the original randomization and did not withdraw from the study are eligible for the extension study including those with a history of secondary treatment following PACT RCT study participation.
Study Type
OBSERVATIONAL
Enrollment
200
Augusta University
Augusta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Atrium Health
Charlotte, North Carolina, United States
Vaginal Mesh or Suture Exposure
Total number of participants (96% with permanent and 86% absorbable suture) will be examined and evaluated for vaginal mesh and/or suture exposure at 2 years or grater time period. Exposure of the suture or mesh will be defined upon the visual examination in the clinic, It is expected to identify \<10% patient population during examination
Time frame: Post Procedure Evaluation at Minimum 2 years
Vaginal Mesh or Suture Exposure
Total number of participants (96% with permanent and 86% absorbable suture) will be examined and evaluated for vaginal mesh and/or suture exposure at 3 years or grater time period. Exposure of the suture or mesh will be defined upon the visual examination in the clinic, It is expected to identify \<10% patient population during examination
Time frame: Post Procedure Evaluation at 3 years
Anatomic success
Leading edge of the prolapse is at or above the hymen to be evaluate among expected 200 participants. POP-Q assessment will be performed with surgical success being defined as apical descent less than 50% of total vaginal length
Time frame: Post Procedure Evaluation at Minimum 2 years and 3 years
Subjective success
PFDI-20 (Pelvic Floor Disability Index) - Patient denies symptoms of vaginal bulging per question 3, answering "No" or "Yes". Response "Yes" leads to 4 probabilities of bothersome of condition from none to quite a bit (3 scales of symptoms and 0 as "Not at all"). Higher the value indicates a greater degree of bother. It is expected to have \<10% to have bulge symptoms by the end of the study.
Time frame: Post Procedure Evaluation at Minimum 2 years and 3 years
Assessment for re-intervention or re-surgery for recurrence of persistence of POP
No necessary use or additional surgical treatment for prolapse at any time after the initial procedure among expected 200 participants who have had participated in the original PACT study trial. Usage of pessary will be accounted as retreatment with expected \<1% patient population.
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Wake Forest Health Sciences
Winston-Salem, North Carolina, United States
Time frame: Post Procedure Evaluation at Minimum 2 years and 3 years