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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04506177
Other study ID # IRB00036663
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date April 5, 2023

Study information

Verified date January 2024
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date April 5, 2023
Est. primary completion date April 5, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Augusta University Augusta Georgia
United States University of North Carolina Chapel Hill North Carolina
United States Atrium Health Charlotte North Carolina
United States Northwestern University Chicago Illinois
United States Wake Forest Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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