Few Pelvic Organ Prolapse Procedures Show Edge
BRISBANE, AUSTRALIA—A detailed meta-analysis of the evidence related to the optimal surgical management of pelvic organ prolapse (POP) shows that only a few procedures have stood the test of time, and some have failed.
According to a Cochrane review presented at the International Urogynecological Association's 2012 annual meeting, studies have not uncovered a clear advantage of anterior compartment mesh utilization over anterior repair (colporrhaphy). Nor is transvaginal mesh better than native tissue repairs in apical or posterior compartment prolapse, and mesh also carries with it an increased risk of intervention in the short term, the team concluded.
“We found a clear advantage in objective and subjective assessment of outcomes from mesh repair as compared to native tissue repairs: The downside was increased perioperative morbidity, post operative stressn urinary incotinence, increased complications, primarily mesh exposure, and operations to correct this,” said senior author Christopher Maher, MD. “There is clearly a downside to mesh interventions.”
Dr. Maher, of the Wesley Private Hospital and Royal Brisbane Women's Hospital, together with three other clinician-researchers, reviewed 54 randomized, controlled trials involving a total of 5,775 women. Their goal was to update a review they completed in 2010 (Cochrane Database Syst Rev 2010;(4):CD004014). The new review included 15 trials that had not been published or presented when the 2010 review was conducted, as well as 10 major updates of prior studies.
Prolapse of the anterior compartment has been examined in 22 clinical trials, including six that were not included in the 2010 Cochrane review. Ten of the trials compared native tissue repair (colporrhaphy) and synthetic non-absorbable mesh repair and six compared native tissue repair and biological grafts.
Anterior colporrhaphy is associated with a nearly twofold lower total reoperation rate for POP and a 1.75-fold lower rate of operation for de novo stress urinary incontinence compared with placement of transvaginal polypropylene mesh. These are significant advantages over mesh, the Cochrane reviewers pointed out. Native tissue repair also has the advantages of lower operating time and less intraoperative blood loss.
The meta-analysis revealed, however, that anterior colporrhaphy is associated with a 64% higher objective failure rate than any biological graft and a 291% higher rate than any graft material. It is also associated with over 300% higher rates of objective failure than polypropylene mesh anterior repair. Unfortunately, the gains in objective outcomes did not translate into improved quality of life outcomes and sexual function, which were similar in the mesh and no mesh groups. There also is strong tendency towards more follow-up prolapse or continence surgery with anterior colporrhaphy versus transobturator mesh.
The reviewers also assessed transvaginal mesh in the posterior and apical regions of the vagina. They found no evidence of efficacy of polypropylene mesh or small-intestine submucosa in posterior compartment repairs, stating that “posterior colporrhaphy fascial repair remains the gold standard,” including its superiority over transanal repair.
Two randomized controlled trials included in the meta-analysis evaluated commercial mesh kits for conditions other than anterior compartment prolapse and showed “no advantage and plenty of downside,” Dr. Maher added. “These kits have been marketed aggressively since 2003-2004 for anterior posterior and apical prolapse—and now eight years later we have only two randomized, controlled trials and they show a definite downside to their use.”
Dr. Maher pointed out that this summer Johnson & Johnson withdrew transvaginal prolapse mesh products from the market in the United States and is planning to halt their sales worldwide. This follows 2009 and 2011 FDA alerts warning of serious complications from transvaginal mesh for POP repairs. Lawsuits have been filed against most companies that market transvaginal mesh due to allegations that women have been harmed by these products.
Additionally, the authors determined that for apical-compartment repairs, abdominal sacral colpopexy for apical prolapse is superior to native tissue repairs and apical transvaginal mesh. However, there is only limited evaluation of the optimal rout for performing abdominal sacral colpopexy, they found.
For its part, the robotic approach “is the most expensive” option, Dr. Maher said, and the single randomized controlled trial of its kind showed robotic surgery does not have advantages over the laparoscopic approach to justify the extra cost of the robotic approach.
The investigators concluded that significant additional well-designed research is needed for most of the surgical procedures utilized for POP treatment. The authors stressed that importance of having blinded independent reviewers evaluating the outcomes to minimize the risk of introducing any biases and that formal cost evaluations should be included in all future studies.