Permanent Versus Absorbable Colpopexy Trial

Completed · Not applicable

Conditions studied: Pelvic Organ Prolapse

In brief

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

Key facts

Study ID

NCT02277925

Run by

University of North Carolina, Chapel Hill

People needed

204

Starts

2015-04-07

Expected to finish

2019-10-07

Last updated by the study team

2019-11-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Augusta University Medical Center — Augusta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• UNC Chapel Hill — Chapel Hill, North Carolina, United States
• Carolinas HealthCare System — Charlotte, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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