Objective
The purpose of this study was to show 12-month outcomes of a randomized trial that compared vaginal prolapse repair with and without mesh.
Study Design
Women with stage ≥2 prolapse were assigned randomly to vaginal repair with or without mesh. The primary outcome was prolapse stage ≤1 at 12 months. Secondary outcomes included quality of life and complications.
Results
All 65 evaluable participants were followed for 12 months after trial stoppage for mesh exposures. Thirty-two women had mesh repair; 33 women had traditional repair. At 12 months, both groups had improvement of pelvic organ prolapse-quantification test points to similar recurrence rates. The quality of life improved and did not differ between groups: 96.2% mesh vs 90.9% no-mesh subjects reported a cure of bulge symptoms; 15.6% had mesh exposures, and reoperation rates were higher with mesh.
Conclusion
Objective and subjective improvement is seen after vaginal prolapse repair with or without mesh. However, mesh resulted in a higher reoperation rate and did not improve 1-year cure.
The use of mesh to augment vaginal prolapse repairs has become a topic of considerable debate over the past few years. Proponents of mesh use point to the up to 30% reoperation rate quoted in some studies for traditional vaginal prolapse repair surgeries. Initial retrospective and prospective cohort studies showed high success rates with few complications. A few published studies have shown some benefit of synthetic mesh-augmented procedures over traditional repairs for the anterior compartment. However, the rise in mesh augmentation led to increased reports of mesh-related complications, which prompted a Food and Drug Administration advisory about the use of mesh in pelvic surgery. Given the rise in litigation surrounding mesh repairs, particularly after the Food and Drug Administration advisory, some investigators recently have suggested that separate consent forms be used for prolapse repair that involves mesh. This makes the analysis of the potential risks and benefits of mesh for vaginal prolapse repair more important than ever.
Currently, no double-blind randomized controlled trials (RCTs) have evaluated the long-term effectiveness of these procedures for multicompartment prolapse. The primary objective of this double-blind, multicenter RCT was to test the hypothesis that the addition interpositional polypropylene mesh improves the 1-year objective treatment success (pelvic organ prolapse–quantification [POP-Q] stage ≤1) of vaginal reconstructive surgery for pelvic organ prolapse compared with traditional vaginal reconstructive surgery without mesh. Secondary objectives were to compare patient satisfaction, quality-of-life (QOL) variables, short-term and long-term complications, vaginal caliber and morbidity that were related to mesh use between the 2 arms of the trial.
Materials and Methods
This multicenter, double-blind RCT was conducted by 6 fellowship-trained pelvic reconstructive surgeons at Washington Hospital Center, Stanford University and Yale University. Institutional review board approval was obtained at each site, and all women provided written informed consent to participate. A detailed description of the study methods and trial design has been published previously. Briefly, women with POP-Q prolapse stages 2-4 were assigned randomly to traditional vaginal prolapse repair without mesh (primarily combined anterior/posterior colporrhaphy and uterosacral ligament suspension) or vaginal colpopexy with mesh (Prolift; Ethicon Women’s Health and Urology, Somerville, NJ). Random assignment occurred with computer-generated random numbers that were stratified for presence or absence of a uterus. Opaque sealed envelopes were opened in the operating room after the patient received anesthesia. The research study nurse coordinator at each site, other research staff, and the patient were masked to the treatment assignment. The primary outcome measure was objective treatment success (POP-Q stage ≤1) at 12 months. Secondary outcome measures included QOL variables, lower urinary tract function, vaginal caliber, and complication rates. Stopping criteria were set with the use of a .001 level of significance and a >15% observed mesh exposure rate, >1% mesh infection rate, >1% fistula formation, and >5% rate of de novo dyspareunia.
Surgery
The surgical techniques in both the mesh and no-mesh groups have been described previously. The techniques for the procedures were standardized for uniformity and included choice of sutures for uterosacral ligament suspension or sacrospinous fixation (combination delayed absorbable polydioxanone sutures [Ethicon, Somerville, NJ]) and permanent polytetrafluoroethylene sutures (Gore-tex; W.L. Gore & Associates, Flagstaff, AZ) and a choice of vaginal mesh kit (Prolift). Apical suspension with uterosacral ligament suspension or sacrospinous suspension (no-mesh arm) vs total vaginal mesh (total Prolift) or modification (anterior Prolift with the insertion of the posterior arms through the sacrospinous ligament; mesh arm) was performed if the cuff or posterior fornix was <3 cm proximal to hymeneal remnant (point C and D ≥ –3) or if the surgeon believed there to be the need for additional apical support. The uterosacral ligament suspension was conducted as described by Shull et al ; the Prolift procedures were performed in accordance with product recommendations. To maintain patient masking, steristrips were placed on the vulva after the surgery (to mimic dressings placed after Prolift), regardless of treatment assignment.
All surgeons were fellowship trained and had performed >30 vaginal colpopexy procedures with uterosacral and sacrospinous ligaments and a minimum of 10 Prolift procedures before patients were enrolled in the trial.
Outcome measures
The primary outcome measure for objective treatment success was overall POP-Q stage ≤1 (descent at >1 cm proximal to the hymen) at 1 year. The need for additional surgical treatment or pessary placement for recurrent prolapse at any time after the initial procedure also constituted treatment failure. These definitions conform to the recommendations from the National Institutes of Health Terminology Workshop for Researchers in Female Pelvic Floor Disorders.
The secondary outcome measures for objective treatment success consisted of anterior, apical, and posterior prolapse stage ≤1 (Ba, Bp, and C >1 cm proximal to the hymen) at 1 year. POP-Q measurements were obtained at 3 and 12 months and yearly thereafter by blinded examiners who had been trained in the performance of POP-Q. For the secondary outcomes, each compartment was analyzed separately for cure. Socioeconomic characteristics, risk factors, and preoperative prolapse severity were investigated as possible factors that could influence the outcome in each arm. Impact on QOL was assessed with validated questionnaires. Preoperative QOL questionnaires were completed at enrollment, at 3 and 12 months, and yearly thereafter. A research nurse coordinator updated contact information, medical history, and adverse events during a 6-month postoperative telephone interview. The following validated QOL tools were used: the SF-12 with both Physical Component Summary and Mental Component Summary, the short forms of Pelvic Floor Distress Inventory that included subscales of Pelvic Organ Prolapse Distress Inventory, the Colorectal Anal Distress Inventory, the Urogenital Distress Inventory, the Pelvic Floor Impact Questionnaire with the corresponding Colorectal Anal Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire and the Urinary Impact Questionnaire, the Prolapse and Incontinence Sexual Questionnaire, the Patient Global Impression of Improvement, and the Patient Global Impression of Severity.
Perioperative measures of morbidity that included operative time, estimated blood loss, and intra- and postoperative complications were recorded at the completion of surgery, at hospital discharge, and at the 6-week postoperative visit. Complications were categorized with a modification of the Dindo Classification.
Women who completed at least approximately 1 year of follow-up evaluation were compared with respect to changes in vaginal caliber that was measured by a ring pessary (diameter in centimeters) at baseline, at 3 and 12 months, and yearly thereafter; to vaginal volume (formula: volume of a cylinder πr total vaginal length; cubed centimeters), and POP-Q measurements. One-year Prolapse and Incontinence Sexual Questionnaire-12 scores and dyspareunia for sexually active women were compared with baseline.
Statistical methods
Methods of data analysis and sample size calculation have been described previously. SPSS software for Windows (version 16; SPSS Inc, Chicago, IL) was used for data management and statistical analysis. A .05 significance level was used for all statistical tests. No 1-sided tests were done. For vaginal caliber and sexual function, Mann-Whitney, χ 2 , Fisher’s exact, and Spearman correlation tests were used for statistical analysis. Survival analysis methods were used to analyze times to recurrence, because these variables had censored data. The log-rank test and Cox proportional hazards regression were used to compare independent groups with respect to recurrence and exposure. Means are presented as mean ± standard deviation or mean (range). Medians are presented as median (range). Data that were obtained after repeat surgery for prolapse recurrence were not included in the analyses, which was done to eliminate the chance that data would be skewed toward improved outcomes after repeat surgery.
Results
Recruitment began on January 3, 2007, and continued until August 1, 2009, at which time the study was halted because of predetermined criteria for vaginal mesh exposure at a mean follow-up time of 7.2 months (range, 2.1–14.7 months). Recruited patients were then observed until all evaluable participants (60/65; 92.3%) reached ≥12 months of follow up (mean, 14.7 months) with a POP-Q evaluation. Enrollment and disposition of the trial are summarized in the Figure . The conditions of 5 patients in the mesh arm were not evaluable at 12 months and were thus censored from the analysis: 1 patient died of a myocardial infarction after 3.7 months; 1 patient did not return for follow-up evaluation after 7.2 months, and 3 patients needed additional prolapse surgery at <12 months of follow up (4.6, 9.8, and 10.2 months). All patients in the no-mesh arm were evaluated at 12 months. Thirty-two subjects (49.2%) had mesh surgery; 14 of these subjects (44%) had undergone hysterectomy earlier. Thirty-three subjects (50.8%) had no-mesh surgery; 12 of these subjects (36%) had undergone hysterectomy earlier. Baseline characteristics did not differ significantly between these 2 groups ( Table 1 ). With the exception of posterior repair that was performed more commonly in the no-mesh group (56% vs 82%; P = .026), similar procedures were performed concomitantly in each group. Operative times were similar between the mesh (3.0 ± 0.8 hours) and no-mesh groups (3.1 ± 1.0 hours; P = .53). Estimated blood loss was also similar (mesh group, 124.5 ± 79.7 mL vs no-mesh group, 154.5 ± 107.1 mL; P = .29).
| Characteristic | Group Mesh | No mesh | P value |
|---|---|---|---|
| Age, y a | 64.4 ± 10.8 | 63.5 ± 8.9 | .61 |
| Race, n (%) | .70 b | ||
| White | 20 (62.5) | 22 (66.7) | |
| African American | 8 (25.0) | 7 (21.2) | |
| Hispanic | 3 (9.4) | 3 (9.1) | |
| Asian | 1 (3.1) | 0 | |
| Other | 0 | 1 (3.0) | 0 |
| Postmenopausal, n (%) | 30 (93.8) | 31 (93.9) | 1 |
| Married, n (%) | 20 (62.5) | 21 (63.6) | .92 |
| Educational level, n (%) | .40 | ||
| <High school | 0 | 2 (6.1) | |
| Completed high school | 10 (31.3) | 11 (33.3) | |
| College or graduate | 22 (68.8) | 20 (60.6) | 0 |
| Health insurance, n (%) | .54 | ||
| Private | 15 (46.9) | 18 (54.5) | |
| Medicare | 17 (53.1) | 15 (45.5) | |
| Current smoker, n (%) | 4 (12.5) | 2 (6.1) | .43 |
| Parity n | 2.4 ± 1.1 | 2.6 ± 0.9 | .30 |
| Previous vaginal deliveries, n | 2.3 ± 1.2 | 2.5 ± 0.8 | .28 |
| Hysterectomy, n (%) | 14 (43.8) | 12 (36.4) | .54 |
| Previous surgery for prolapse, n (%) | 4 (12.5) | 0 | .053 |
| Previous surgery for incontinence, n (%) | 2 (6.3) | 1 (3.0) | .61 |
| Body mass index, kg/m 2 | 27.4 ± 5.1 | 27.8 ± 6.4 | .71 |
| Body mass index ≥30 kg/m 2 , n (%) | 8 (25.0) | 9 (27.3) | .84 |
| Pelvic organ prolapse–quantification stage, n (%) | .51 | ||
| II | 7 (21.9) | 4 (12.1) | |
| III | 20 (62.5) | 24 (72.7) | |
| IV | 5 (15.6) | 5 (15.2) | |
| Pelvic organ prolapse–quantification measurements, cm c | |||
| Ba | 3.0 (0.0–13.5) | 4.0 (−0.5 to 9.0) | .29 |
| Bp | −1.0 (−3.0 to 13.5) | −1.0 (−3.0 to 8.0) | .75 |
| C | −0.8 (−7.5 to 13.5) | 2.0 (−8.0 to 9.0) | .26 |
| GH | 5.0 (2.0–8.0) | 5.0 (2.5–8.0) | .27 |
| PB | 4.0 (2.0–5.0) | 3.5 (1.0–5.5) | .15 |
| Total vaginal length | 9.0 (6.5–13.5) | 9.0 (7.0–11.5) | .50 |
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