Clinical Trial: Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Prospective Randomized Trial of Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis

Brief Summary: 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.

Detailed Summary:

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
Sponsor: Kaiser Permanente

Current Primary Outcome: Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis [ Time Frame: 5 years ]

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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse events [ Time Frame: 5 years ]

    Secondary outcomes include

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

  • Overall failure rate [ Time Frame: 5 year ]

    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.

  • Postoperative quality of life [ Time Frame: 5 Year ]

    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.

  • Postoperative sexual function [ Time Frame: 5 year ]

    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.



Original Secondary Outcome:

  • Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Graft [ Time Frame: 5 years ]

    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 ]

    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 ]

    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 ]

    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.



Information By: Kaiser Permanente

Dates:
Date Received: June 28, 2011
Date Started: October 2005
Date Completion: December 2017
Last Updated: March 24, 2017
Last Verified: March 2017