For repair of anterior vaginal-wall prolapse, the use of a trochar-guided mesh kit was more successful than traditional colporrhaphy on both objective and subjective measures, according to a report in the May 12 issue of the New England Journal of Medicine.
The mesh kit, however, carried higher rates of surgical complications and postoperative adverse events, with twice as many women developing new stress urinary incontinence and more than three times as many reporting dyspareunia in the year following surgery, said Dr. Daniel Altman of Danderyd Hospital and the Karolinska Institutet, Stockholm, and his associates.
The use of trocar-guided mesh kits is widespread, even though "none of the marketed kits have been comprehensively evaluated in comparative trials," they noted.
Dr. Altman and his colleagues performed such a trial, comparing the efficacy and safety of transvaginal mesh repair against colporrhaphy, the current standard of care, in 389 women at 53 hospitals throughout Sweden, Norway, Finland, and Denmark. The 58 surgeons who participated in the study performed a median of three each of the two types of procedures.
The study subjects were randomly assigned in approximately equal numbers to undergo either traditional colporrhaphy or trocar-guided transvaginal mesh repair. They were followed at 2 months and 12 months, giving subjective responses to the Urogenital Distress Inventory (UDI) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). In addition, gynecologists objectively assessed postoperative results using the Pelvic Organ Prolapse Quantification (POP-Q) staging system.
One year after surgery, the primary outcome measure – a finding of no prolapse on both subjective and objective assessments – was significantly more frequent in the mesh-repair group (61%) than in the colporrhaphy group (35%). This result was consistent upon further per-protocol analysis, intention-to-treat analysis, and sensitivity analysis, the investigators said (N. Engl. J. Med. 2011;364:1826-36).
At 1 year, the proportion of women in whom support of the anterior vaginal wall was restored to POP-Q stage 0 or 1 was 82% with the mesh kit, compared with 48% with colporrhaphy.
The proportion of women who reported symptoms of vaginal bulging was 75% with the mesh kit, compared with 62% with colporrhaphy.
Urinary symptom scores deteriorated in both groups during the course of the year but did so to a greater degree with colporrhaphy. "At the 1-year assessment, symptoms of stress urinary incontinence were significantly more bothersome in the mesh-repair group ... whereas obstructive symptoms were less bothersome; there were no significant between-group differences in irritative symptoms at 1 year," Dr. Altman and his associates said.
New stress urinary incontinence, however, developed in only 6% of the colporrhaphy group, compared with 12% of the mesh-repair group.
PISQ-12 scores were only modestly improved, compared with baseline scores, and were similar between the two groups.
Pain during sexual intercourse was reported "usually" or "always" by 2% of patients after colporrhaphy and by over 7% of women after transvaginal mesh surgery, yet 40% of the colporrhaphy group and 48% of the mesh-repair group said they were "usually" or "always" satisfied with their sexual relationships.
The mesh-repair group had a significantly longer mean duration of surgery (53 minutes vs. 34 minutes), greater intraoperative blood loss (85 mL vs. 35 mL), a more frequent need for intraoperative cystoscopy, and more bladder perforations (seven vs. one). The rates of excessive blood loss, inguinal pain, and problems emptying the bladder also were higher after mesh repair.
In addition, more patients in the mesh-repair group reported severe pelvic pain at 2 months. And within 1 year, nearly 3% of women who had undergone mesh repair required surgery for stress incontinence and more than 3% required surgical revision because of exposure of the mesh.
"Patients should understand ... that the use of mesh may cause complications even after the immediate postoperative period," the researchers noted.
"Our results highlight the need for a careful evaluation of surgical innovations, which are often widely adopted in the absence of data from clinical trials," they said.
This study was supported by the Swedish Society of Medicine, the Karolinska Institutet, and Ethicon. Dr. Altman reported ties to Gynecare Scandinavia, and Contura. Some of the other investigators reported ties to Gynecare Scandinavia and Ethicon.