NCT04506177

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2023

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

2.8 years

First QC Date

August 5, 2020

Last Update Submit

January 25, 2024

Conditions

HysterectomySacrocolpopexy

Keywords

Pelvic Organ ProlapseVaginal mesh

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Anatomic success

    Post Procedure Evaluation at Minimum 2 years and 3 years

  • Subjective success

    Post Procedure Evaluation at Minimum 2 years and 3 years

  • Assessment for re-intervention or re-surgery for recurrence of persistence of POP

    Post Procedure Evaluation at Minimum 2 years and 3 years

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients with the history of hysterectomy and sacrocolpopexy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Augusta University

Augusta, Georgia, 30912, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Atrium Health

Charlotte, North Carolina, 28207, United States

Location

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine A Matthews, MD

    Wake Forest Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 10, 2020

Study Start

July 1, 2020

Primary Completion

April 5, 2023

Study Completion

April 5, 2023

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(5)