Overview

This trial is active, not recruiting.

Conditions anterior vaginal wall prolapse, cystocele, pelvic organ prolapse
Treatments polypropylene mesh (polyform by boston scientific), porcine dermis (pelvicol by crbard), anterior colporrhaphy
Phase phase 4
Sponsor Kaiser Permanente
Start date October 2005
End date December 2015
Trial size 100 participants
Trial identifier NCT01393171, IRB4358, KPSC IRB 4358

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Site-specific cystocele repair with polypropylene mesh augmentation
polypropylene mesh (polyform by boston scientific) Polyform by Boston Scientific
Site-specific cystocele repair with polypropylene mesh augmentation
(Placebo Comparator)
Anterior vaginal prolapse repair with anterior colporrhaphy with no graft.
anterior colporrhaphy Cystocele repair
Anterior vaginal prolapse repair with suture.
(Active Comparator)
Site-specific cystocele repair with porcine dermis augmentation
porcine dermis (pelvicol by crbard) Pelvicol by CRBard
Site-specific cystocele repair with porcine dermis augmentation

Primary Outcomes

Measure
Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis
time frame: 5 years

Secondary Outcomes

Measure
Adverse events
time frame: 5 years
Overall failure rate
time frame: 5 year
Postoperative quality of life
time frame: 5 Year
Postoperative sexual function
time frame: 5 year

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Prospective Randomized Trial of Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis
Principal investigator John N. Nguyen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Kaiser Permanente.