Clinical trial NCT01393171: Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis
Official title: Prospective Randomized Trial of Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Vaginal Wall Prolapse
Cystocele
Pelvic Organ Prolapse
Keywords: Anterior Vaginal Prolapse
Cystocele
Pelvic Organ Prolapse
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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.

Primary outcomes:
measure: Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis
timeFrame: 2 years
Secondary outcomes:
measure: Number of Participants With One or More Adverse Events at Two Years
timeFrame: 2 years
measure: Number of Participants With Overall Failure
timeFrame: 2 year
measure: Change in Quality of Life Measured by the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7
timeFrame: 2-year compared to baseline scores
measure: Change in Postoperative Sexual Function Measured by Pelvic Organ Prolapse/Urinary Incontinence Questionnaire 12
timeFrame: 2 year
Other outcomes:
Locations:
city: Downey
country: United States
facility: Kaiser Permanente
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
Study officials:
affiliation: Kaiser Permanente
name: John N. Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weber AM, Walters MD, Piedmonte MR, Ballard LA. Anterior colporrhaphy: a randomized trial of three surgical techniques. Am J Obstet Gynecol. 2001 Dec;185(6):1299-304; discussion 1304-6. doi: 10.1067/mob.2001.119081.
citation: Altman D, Vayrynen T, Engh ME, Axelsen S, Falconer C; Nordic Transvaginal Mesh Group. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med. 2011 May 12;364(19):1826-36. doi: 10.1056/NEJMoa1009521.
citation: Simsiman AJ, Luber KM, Menefee SA. Vaginal paravaginal repair with porcine dermal reinforcement: correction of advanced anterior vaginal prolapse. Am J Obstet Gynecol. 2006 Dec;195(6):1832-6. doi: 10.1016/j.ajog.2006.07.005. Epub 2006 Sep 28.
citation: Menefee SA, Dyer KY, Lukacz ES, Simsiman AJ, Luber KM, Nguyen JN. Colporrhaphy compared with mesh or graft-reinforced vaginal paravaginal repair for anterior vaginal wall prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1337-1344. doi: 10.1097/AOG.0b013e318237edc4.