Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis (OARS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
John N Nguyen, Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01393171
First received: June 28, 2011
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to evaluate the success rate of cystocele repair using polypropylene mesh or porcine dermis compared to that of anterior colporrhaphy in a prospective randomized fashion. The study will be performed in a randomized, prospective, single-blinded fashion.


Condition Intervention Phase
Anterior Vaginal Wall Prolapse
Cystocele
Pelvic Organ Prolapse
Device: Polypropylene mesh (Polyform by Boston Scientific)
Procedure: Porcine Dermis (Pelvicol by CRBard)
Procedure: Anterior Colporrhaphy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The primary outcome of this investigation will be postoperative anterior vaginal support measured by the validated scale(POP-Q, POP-Q point Ba performed by blinded examiner. Anatomic support will be considered optimal when Ba by POP-Q being at stage 0 or 1 (Ba=-2,-3).


Secondary Outcome Measures:
  • Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Graft [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    Secondary outcomes include

    *hospital data including intra-operative data complications (genito-urinary tract injury) and estimated blood loss. Postoperative length of stay.


  • Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Graft [ Time Frame: 5 year ] [ Designated as safety issue: No ]

    Secondary Outcome Include:

    *Overall Failure rate which includes subjective symptoms of vaginal bulge and anatomic/objective measure, POP-Q point of Ba. This secondary outcome represents a composite outcome.


  • Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Graft [ Time Frame: 5 Year ] [ Designated as safety issue: No ]

    Secondary Outcome include:

    *Quality Of Life- A secondary outcome on subjective bother involving pelvic floor disorders using several validated scales including PFDI-20 and PFIQ-7 will be measured at 6 months, 12 months and 24 months.


  • Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Graft [ Time Frame: 5 year ] [ Designated as safety issue: No ]

    Secondary Outcome Include:

    *Sexual Function: A secondary outcome on subjective bother involving pelvic floor disorders using a validated scale, PISQ-12 questionnaire,will be measured at 6 months, 12 months and 24 months.



Estimated Enrollment: 100
Study Start Date: October 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Polypropylene Mesh
Site-specific cystocele repair with polypropylene mesh augmentation
Device: Polypropylene mesh (Polyform by Boston Scientific)
Site-specific cystocele repair with polypropylene mesh augmentation
Other Name: Polyform by Boston Scientific
Placebo Comparator: Anterior Colporrhaphy
Anterior vaginal prolapse repair with anterior colporrhaphy with no graft.
Procedure: Anterior Colporrhaphy
Anterior vaginal prolapse repair with suture.
Other Name: Cystocele repair
Active Comparator: Porcine Dermis
Site-specific cystocele repair with porcine dermis augmentation
Procedure: Porcine Dermis (Pelvicol by CRBard)
Site-specific cystocele repair with porcine dermis augmentation
Other Name: Pelvicol by CRBard

Detailed Description:

Study participants will be recruited from the urogynecology clinic at Kaiser Permanente Medical Center Bellflower and San Diego. Clinical evaluation of each patient will include a standardized history, voiding diary, quality of life (UDI-6 & IIQ-7)10 and sexual function (PISQ-12)11-12 questionnaires (Attachment 1), urinalysis, gynecologic and pelvic organ prolapse quantification (POPQ) examinations. Patients will be randomized by a computer-generated randomization schedule, with allocation to either anterior colporrhaphy or site-specific cystocele repair with polypropylene mesh augmentation or site-specific cystocele repair with porcine dermis augmentation. The allocated treatment arm will be concealed in a sealed opaque envelope until the day of surgery. Patients will be given vaginal estrogen cream starting six weeks prior to surgery. Intravenous antibiotic prophylaxis will be given preoperatively and continued postoperatively for 24 hours. Vaginal infiltration will be performed with 0.25% bupivacaine and epinephrine (1:200,000) solution. Anterior colporrhaphy is performed by making a midline incision through the anterior vaginal mucosa, dissecting the vaginal epithelium from the underlying muscularis, and midline plication of the muscularis with No. 2-0 polydioxanone sutures (Ethicon, Somerville, NJ). The excess vaginal mucosa is then excised and the margins of the vagina reapproximated in the midline using No. 2-0 polyglactin (Vicryl) sutures. Patients who are randomized to polypropylene mesh or porcine dermis repair will undergo a site-specific defect repair of the vaginal muscularis with No. 2-0 polydioxanone sutures after midline vaginal incision and lateral dissection. A piece of the assigned material will be fashioned to fit the repaired space and anchored bilaterally to the arcus tendineus fascia pelvis with interrupted No. 2-0 polydioxanone sutures. Other operative procedures will be performed as indicated. TVT or TVT-O procedures (Gynecare Inc., Somerville, NJ) will be performed for stress urinary incontinence as previously described through a separate midurethral vaginal incision. The vagina will be packed for 24 hours. All patients will be discharged when they are able to ambulate and tolerate a solid diet and oral pain medication.

The two groups will be evaluated at 6 weeks, 6 months, 1 and 2 years after surgery. A trained clinical nurse/clinical fellow, whom has been proctored in performance of POP-Q exams, will perform postoperative POPQ staging in all patients. A research nurse blinded to the subject's group assignment will administer preoperative and postoperative quality of life and sexual function questionnaires. The primary outcome of this investigation will be postoperative anterior vaginal support. Anatomic success is defined as point Ba< -1. Secondary outcomes including hospital data, complications, subjective continence, quality of life and sexual function, and overall satisfaction with surgery, will also be compared.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Stage 2 or > anterior vaginal prolapse requiring surgical correction.
  • >18 years old
  • willing to return for follow-up visits.

Exclusion Criteria:

  • Less than stage II or > anterior vaginal prolapse,
  • decline to participate,
  • pregnant or contemplating future pregnancy,
  • anti-incontinence procedure other than midurethral sling (ie, Burch colposuspension, pubovaginal sling, or needle suspension) is planned as part of their surgical procedures,
  • any contra-indication to receiving mesh or porcine dermis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393171

Locations
United States, California
Kaiser Permanente
Downey, California, United States, 90242
Kaiser Permanente
San Diego, California, United States, 92110
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: John N. Nguyen, MD Kaiser Permanente
  More Information

No publications provided

Responsible Party: John N Nguyen, Partner Physician, Attending Physician, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01393171     History of Changes
Other Study ID Numbers: IRB4358, KPSC IRB 4358
Study First Received: June 28, 2011
Last Updated: October 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Anterior Vaginal Prolapse
Cystocele
Pelvic Organ Prolapse

Additional relevant MeSH terms:
Cystocele
Pelvic Organ Prolapse
Prolapse
Uterine Prolapse
Genital Diseases, Female
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Uterine Diseases

ClinicalTrials.gov processed this record on October 23, 2014