Posted July 2014
Research lead by Dr Carey was presented in Washington at the combined International Urogynecology Association and American Urogynecology Association meeting. This long-term research was conducted by the Urogynaecology Department at The Royal Women’s Hospital. An earlier publication of this research was used by the United States Food and Drug Authority (FDA) in making recommendations about the use of trans-vaginal mesh during prolapse surgery.
Here is an abstract of this research:
Title: Native tissue repair versus mesh for trans-vaginal prolapse surgery: 5-year follow-up RCT.
Authors: Dr Ruchi Singh, Ms Ann Cornish and Dr Marcus Carey (principle investigator).
Introduction: There is a paucity of published data on the long-term safety and effectiveness of trans-vaginal mesh in prolapse surgery when compared to native tissue repair. The role of mesh in trans-vaginal prolapse surgery has come into sharp focus following FDA warning about safety concerns. Even though the rate of trans-vaginal mesh usage has declined dramatically since the FDA warning, long term studies, including studies with negative outcomes, will always play an important role in our understanding the surgical management of pelvic organ prolapse.
Objective: To compare the long term (5-year) anatomic and functional outcomes of vaginal prolapse repair with mesh augmentation versus native tissue repair in an RCT study.
Methods: An RCT study of 129 women with ≥ Stage II prolapse requiring both anterior and posterior vaginal compartment repair randomized to either native tissue repair (no mesh group) or vaginal repair mesh augmentation (mesh group) in both anterior and posterior compartments. Mean age of 59.1 years in the mesh group and 57.6 years in the no mesh group. The rates of prior prolapse surgery and hysterectomy were not significantly different between the two groups. The decision to include only subjects who required repair of both anterior and posterior compartments was chosen to avoid the potential confounding effect of different compartment being repaired in different participants. Gynemesh (Ethicon, NJ) was used in the mesh group. An oval shaped mesh with lateral straps was used in the anterior compartment with the straps inserted into the paravaginal spaces on each side. A Y-shaped mesh was used in the posterior compartment with the straps of the mesh placed onto each sacrospinous ligament. Participants underwent a mid-urethral sling, vaginal hysterectomy and/or sacrospinous ligament fixation as required. As previously reported, there was no significant differences between the groups with respect to additional surgery.1 A clinical POP-Q examination by a blinded assessor and functional outcomes using QOL instruments were administered at each follow up. The primary outcome was objective success based on POP-Q examination. The 5 year primary outcome was altered to include anatomic success defined as the leading edge of vagina ≤ 0cm relative to the hymen as well as the original primary outcome measure of the leading edge of vagina ≤ -2cm relative to the hymen. Secondary outcomes included functional outcomes, complications and QOL questionnaires. Participants were reviewed at 6 months, 12 months, and 5 years. The 6 and 12 month data have previously been reported. 1
Results: At 5 years, 55 participants returned for follow up; 27 in the mesh group and 28 in the no mesh group. Based on the original criteria of objective success with the leading edge of vagina ≤ -2cm relative to the hymen, the objective success rate was 59.25% (16/27) in the mesh group versus 39% (11/28) in the no mesh group and was not significant (P=0.13). Based on a definition of success of the leading edge of vagina ≤ 0cm relative to the hymen the success rate was 96% (26 of 27 patients) in the mesh group and 95.4% (27 of 28 patients) in the no mesh group and was not significant (P=0.18). There was no significant difference in the functional outcomes (including sexual function) and rates of surgical re-intervention for prolapse between the two groups at 6 months, 12 months or 5 years. The cumulative mesh exposure rate at 5 years of 7% (5.9% requiring surgical intervention) was only slightly higher than the 5.6% rate reported at 12 months.
Conclusions: At 5 years, the objective anatomic success rate for vaginal prolapse surgery is not significantly different with mesh augmentation compared to native tissue repair. This finding was similar to a recently publish 5-year follow up of 27,809 women undergoing vaginal prolapse surgery using either mesh or native tissue repair.2 Functional and QOL outcomes were also similar in both groups. The routine use of mesh to augment trans-vaginal prolapse surgery is not supported by this study. The number of participants returning for follow-up at 5 years (42.6%) is typical of long term surgical studies.
References:
1. BJOG 2009; 116: 1380–1386.
2. Int Urogynecol J. 2013 Aug; 24(8):1279-85.