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Permanent Versus Absorbable Colpopexy Trial (PACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277925
Recruitment Status : Completed
First Posted : October 29, 2014
Results First Posted : November 8, 2019
Last Update Posted : November 19, 2019
Sponsor:
Collaborators:
Northwestern University
Augusta University
Wake Forest University Health Sciences
Atrium Health
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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. 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. To evaluate adverse outcomes in each group

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Other: Polytetrafluoroethylene Other: Polydioxanone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Permanent Versus Delayed-absorbable Monofilament Suture for Vaginal Graft Attachment During Minimally-invasive Total Hysterectomy and Sacrocolpopexy: A Randomized Clinical Trial
Actual Study Start Date : April 7, 2015
Actual Primary Completion Date : October 7, 2019
Actual Study Completion Date : October 7, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Gore-Tex permanent suture
Participants in this arm will receive Gore-Tex permanent suture
Other: Polytetrafluoroethylene
Suture used to attach mesh during sacral colpopexy surgery
Other Name: Gore-Tex permanent suture

Experimental: PDS delayed absorbable suture
Participants in this arm will receive 2-0 PDS delayed absorbable suture
Other: Polydioxanone
Suture used to attach mesh during sacral colpopexy surgery
Other Name: 2-0 PDS delayed absorbable monofilament suture




Primary Outcome Measures :
  1. Number of Participants With Vaginal Mesh or Suture Exposure [ Time Frame: 1 year ]
    Total number of participants with vaginal mesh and/or suture exposure thru 1 year


Secondary Outcome Measures :
  1. Number of Participants With Treatment Success [ Time Frame: 1 year ]
    Total number of participants with treatment success, which was a composite measure of 1) leading edge of prolapse not beyond hymen and apex not descended > 1/3 of vaginal length, 2) no subjective feeling of bulge on validated questionnaire, and 3) no prolapse re-treatment with pessary or surgery

  2. Pelvic Floor Distress Inventory-20 (PFDI-20) Mean Score [ Time Frame: 1 year ]
    Condition-specific questionnaire, pelvic floor distress inventory-20 (PFDI-20) is used. Minimum value is 0. Maximum is 300. Higher scores mean more bothersome symptoms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Subject is not able to conform to steep trendelenburg position
  • Known sensitivity to polypropylene

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277925


Locations
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United States, Georgia
Augusta University Medical Center
Augusta, Georgia, United States, 30912
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27516
Carolinas HealthCare System
Charlotte, North Carolina, United States, 28207
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27595
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Northwestern University
Augusta University
Wake Forest University Health Sciences
Atrium Health
Investigators
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Principal Investigator: Elizabeth Geller, MD University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02277925    
Other Study ID Numbers: 14-2402
First Posted: October 29, 2014    Key Record Dates
Results First Posted: November 8, 2019
Last Update Posted: November 19, 2019
Last Verified: October 2019
Keywords provided by University of North Carolina, Chapel Hill:
Pelvic Organ Prolapse
Vaginal mesh exposure rates
Vaginal suture exposure rates
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical