Permanent Versus Delayed-Absorbable Monofilament Suture

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hysterectomy, Sacrocolpopexy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Permanent Sutures<br>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<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Organ Prolapse, Vaginal mesh