Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2018-04-01

Brief Summary

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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.

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RECRUITING

Detailed Description

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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.

Conditions

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Anterior Vaginal Wall Prolapse Cystocele Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Polypropylene Mesh

Site-specific cystocele repair with polypropylene mesh augmentation

Group Type ACTIVE_COMPARATOR

Polypropylene mesh (Polyform by Boston Scientific)

Intervention Type DEVICE

Site-specific cystocele repair with polypropylene mesh augmentation

Anterior Colporrhaphy

Anterior vaginal prolapse repair with anterior colporrhaphy with no graft.

Group Type PLACEBO_COMPARATOR

Anterior Colporrhaphy

Intervention Type PROCEDURE

Anterior vaginal prolapse repair with suture.

Porcine Dermis

Site-specific cystocele repair with porcine dermis augmentation

Group Type ACTIVE_COMPARATOR

Porcine Dermis (Pelvicol by CRBard)

Intervention Type PROCEDURE

Site-specific cystocele repair with porcine dermis augmentation

Interventions

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Polypropylene mesh (Polyform by Boston Scientific)

Site-specific cystocele repair with polypropylene mesh augmentation

Intervention Type DEVICE

Porcine Dermis (Pelvicol by CRBard)

Site-specific cystocele repair with porcine dermis augmentation

Intervention Type PROCEDURE

Anterior Colporrhaphy

Anterior vaginal prolapse repair with suture.

Intervention Type PROCEDURE

Other Intervention Names

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Polyform by Boston Scientific Pelvicol by CRBard Cystocele repair

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes