Permanent Versus Absorbable Colpopexy Trial

NCT02277925 | Completed Results DMC

• 1 other identifier: 14-2402
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 5

Brief Summary

Primary Aim: The primary aim of this randomized controlled trial (RCT) is to compare vaginal mesh and suture exposure rates in women undergoing robotic total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent (polytetrafluoroethylene, Gore-Tex) versus delayed absorbable monofilament (2-0 polydioxanone, PDS) sutures through 1-year. Secondary Aims:

1. 1.To compare the 1-year composite success rate (leading edge of prolapse is at or above the hymen and apex has descended less than 1/3 of the vaginal length, no subjective feeling of bulge; and no retreatment for pelvic organ prolapse (POP) or vaginal mesh exposure) of permanent versus delayed absorbable sutures for mesh graft attachment during robotic total hysterectomy and sacrocolpopexy.
2. 2.To evaluate adverse outcomes in each group

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic Organ Prolapse; Vaginal mesh exposure rates; Vaginal suture exposure rates

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Vaginal Mesh or Suture Exposure

  Total number of participants with vaginal mesh and/or suture exposure thru 1 year

  1 year

Secondary Outcomes (2)

• Number of Participants With Treatment Success

  1 year

• Pelvic Floor Distress Inventory-20 (PFDI-20) Mean Score

  1 year

Study Arms (2)

Gore-Tex permanent suture

ACTIVE COMPARATOR

Participants in this arm will receive Gore-Tex permanent suture

Other: Polytetrafluoroethylene

PDS delayed absorbable suture

EXPERIMENTAL

Participants in this arm will receive 2-0 PDS delayed absorbable suture

Other: Polydioxanone

Interventions

Polytetrafluoroethylene OTHER

Suture used to attach mesh during sacral colpopexy surgery

Also known as: Gore-Tex permanent suture

Gore-Tex permanent suture

Polydioxanone OTHER

Suture used to attach mesh during sacral colpopexy surgery

Also known as: 2-0 PDS delayed absorbable monofilament suture

PDS delayed absorbable suture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Subject must have apical with anterior or posterior vaginal prolapse with leading edge of prolapse to or beyond the hymen. This is defined as stage 2-4 pelvic organ prolapse ( C \> - (TVL / 2) AND Ba or Bp ≥ 0 by the POP)
• Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit")
• Eligible for robotic or laparoscopic sacral colpopexy
• Desires surgical treatment for primary, symptomatic uterovaginal prolapse
• English speaking
• Willing to undergo hysterectomy

You may not qualify if:

• Patients who had prior hysterectomy
• Patients who are not surgical candidates due to medical comorbidities
• Current foreign body complications (including but not limited to erosion, fistula, abscess). This covers foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft).
• Desires uterine conservation
• Inability to give informed consent or to complete the testing or data collection
• Anticipated circumstances resulting in an inability to follow up (geographic relocation, etc).
• Pregnant or intends to become pregnant
• Active/chronic systemic infection including any gynecologic infection, untreated UTI or tissue necrosis
• History of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
• Prior or currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
• Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
• Systemic connective tissue disease (e.g. scleroderma, Marfan's syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatica)
• Chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
• Poorly controlled diabetes mellitus (DM), as indicated by Hemoglobin A1c \> 9
• Those requiring concomitant rectopexy

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Northwestern University: collaborator
• Augusta University: collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (5)

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

Carolinas HealthCare System

Charlotte, North Carolina, 28207, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27595, United States

Location

Related Publications (1)

• Matthews CA, Geller EJ, Henley BR, Kenton K, Myers EM, Dieter AA, Parnell B, Lewicky-Gaupp C, Mueller MG, Wu JM. Permanent Compared With Absorbable Suture for Vaginal Mesh Fixation During Total Hysterectomy and Sacrocolpopexy: A Randomized Controlled Trial. Obstet Gynecol. 2020 Aug;136(2):355-364. doi: 10.1097/AOG.0000000000003884.

  PMID: 32649494 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Polytetrafluoroethylene; Polydioxanone

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluorocarbon Polymers; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Polyesters; Biocompatible Materials

Results Point of Contact

• Title: Jennifer Wu, MD, MPH
• Organization: University of North Carolina at Chapel Hill

jennifer_wu@med.unc.edu

919-966-0014

Study Officials

• Elizabeth Geller, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 29, 2014
• Study Start: April 7, 2015
• Primary Completion: October 7, 2019
• Study Completion: October 7, 2019
• Last Updated: November 19, 2019
• Results First Posted: November 8, 2019

Record last verified: 2019-10

Locations

US (5)