Permanent Versus Delayed-Absorbable Monofilament Suture (E-PACT)

E-PACT: Extension Trial of Permanent Versus Delayed-absorbable Monofilament Suture for Vaginal Graft Attachment During Minimally-invasive Total Hysterectomy and Sacrocolpopexy

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.

Study Overview

• Status: Completed
• Conditions: Hysterectomy; Sacrocolpopexy

Detailed Description

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 (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Atrium Health
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study Patients who have participated in the PACT Study Trial at one of the following Research Sites:

1. Wake Forest University, Winston-Salem (22 subject participants)
2. University of North Carolina, Chapel Hill
3. Northwestern Medical Center, Chicago
4. Augusta University, Augusta
5. Atrium Health, Charlotte

Description

Inclusion Criteria:

• Patients who have participated in the PACT Study Trial (Permanent Versus Delayed-absorbable Monofilament Suture for Vaginal Graft Attachment During Minimally-invasive Total Hysterectomy and Sacrocolpopexy: A Randomized Clinical Trial)

Exclusion Criteria:

• Patient is not willing to sign consent
• Patient does not want to fill-out questionnaires

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Permanent Sutures; Women who previously received (in the PACT Study Trial) minimally-invasive total hysterectomy and sacrocolpopexy (SCP) with a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent (polytetrafluoroethylene, Gore-Tex) suture for vaginal mesh attachment
Delayed Absorbable Monofilament Sutures; Women who previously received (in the PACT Study Trial) minimally-invasive total hysterectomy and sacrocolpopexy (SCP) with a light-weight polypropylene mesh (Upsylon™ y-mesh) using delayed absorbable monofilament (polydioxanone, PDS) suture for vaginal mesh attachment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Post Procedure Evaluation at 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	Post Procedure Evaluation at Minimum 2 years and 3 years

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Catherine A Matthews, MD, Wake Forest Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): April 5, 2023
• Study Completion (Actual): April 5, 2023

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pelvic Organ Prolapse; Vaginal mesh
• Other Study ID Numbers: IRB00036663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No