Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis

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.

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.