Objective
To evaluate anatomic and functional outcomes at 1-year following trocar-guided transvaginal prolapse repair using a partially absorbable mesh.
Study Design
Prospective multicentre cohort study at 11 international sites. One hundred twenty-seven patients with pelvic organ prolapse stage ≥ III had surgery and were evaluated at 3 months and 1-year postsurgery compared with baseline. Instruments of measurements: Pelvic Organ Prolapse Quantification, Pelvic Floor Distress Inventory-20, Pelvic Floor Impact Questionnaire-7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12, and Patients Global Impression of Change.
Results
Anatomic success, defined as prolapse stage ≤ I in the treated vaginal compartments, was 77.4% (95% confidence interval, 69.0–84.4%). Significant improvements in bother, quality of life, and sexual function were detected at 3 months and 1 year compared with baseline. At 1-year after surgery, 86.2% of patients indicated their prolapse situation to be “much better.” Mesh exposure rate was 10.2% and rate of de novo dyspareunia 2% at 1 year.
Conclusion
These results demonstrate improved anatomic support, associated with excellent functional improvements, without apparent safety concerns.
Pelvic organ prolapse (POP) is a common problem and may occur in up to 50% of parous women. A Dutch cross-sectional study demonstrated a prevalence of symptomatic POP as high as 11.4%. In 2003, more than 300,000 women underwent prolapse surgery in the United States, indicating that POP is among common indications for surgery.
There is increasing evidence that the tension-free vaginal insertion of prosthetic mesh in patients with symptomatic POP reduces the chance of anatomic failure. The introduction of these new materials in pelvic reconstructive surgery has introduced new kinds of morbidity. Among the most prevalent complications are mesh exposure and shrinkage of tissue around the mesh. These may result in pelvic pain and dyspareunia. De novo dyspareunia after traditional POP repair ranges between 14.5% and 36.1% and a recent retrospective study reported a similar rate (16.7%) after repair with a mesh kit system. Prospective studies, and a large retrospective study using such mesh, have reported mesh exposure rates that ranged between 10% and 15%.
The superiority of the lightweight large pore mesh compared with conventional heavier weight mesh with regard to reduced numbers of long-term complications and increased comfort, has been clearly demonstrated in a review on inguinal hernia repair. A trocar-guided mesh system with a nonabsorbable, monofilament polyprolyene mesh was introduced in 2005. One of the key rationales for adopting a new, lighter-weight mesh with improved directional elastic properties was to minimize tissue shrinkage, which may lead to dyspareunia. This new mesh is composed of a 50-50 blend of monofilament nonabsorbable polypropylene and absorbable polyglecaprone 25. Before absorption, this mesh weighs 57 g/m 2 . Full absorption after 90-120 days results in a final weight of 31 g/m 2 , as opposed to the 45 g/m 2 of the original polypropylene mesh. Because of warp knitting, this mesh provides increased elasticity in the longitudinal direction and has larger pores compared with the original mesh to allow more tissue ingrowth.
The primary objective of this study was to assess anatomic and functional outcomes with this new mesh 1-year postsurgery. The secondary objective was to assess adverse events, particularly pain and dyspareunia.
Materials and Methods
The study protocol and informed consent documentation received ethics committee/institutional review board approval at all participating sites. The trial was registered at ClinicalTrials.gov ; NCT00833001 . Eleven urogynecologic centers from Belgium, France, Germany, the Netherlands, and the United States enrolled patients between April and October 2008; 1-year follow-up visits were completed by November 2009. All patients gave written informed consent before participation in the study. Inclusion criteria were POP stage III or IV, according to the Pelvic Organ Prolapse Quantification (POP-Q) classification system. Concurrent hysterectomies and/or perineal repairs were allowed, but exclusion criteria were as follows: other additional surgical repair of prolapse, including paravaginal repair, sacrocolpopexy, and colporrhaphy in a nonmesh-treated compartment; previous prolapse repair using mesh; systemic diseases known to affect bladder or bowel function; and any medical or psychiatric condition that could potentially affect the patient’s ability to complete study visits.
All patients underwent the standardized transvaginal mesh placement technique (Gynecare Prolift+M Pelvic Floor Repair System, referred to as Prolift+M; Ethicon, Somerville, NJ). All surgeons were experienced with the procedure before participation. Depending on the site of prolapse, the mesh repair could be anterior, posterior, or total; in patients with an intact uterus, the total mesh was cut. Concurrent hysterectomies, perineal repairs, and/or midurethral sling procedures were performed at each surgeon’s discretion. Cystoscopy was required for repairs involving the anterior compartment. All procedures were performed under antibiotic coverage, according to the standard of each participating site.
Pelvic examination, including the POP-Q system was performed at baseline, 3 months, and 1 year postsurgery. Subsequent follow-up evaluations will be obtained at 2 and 3 years postsurgery.
The primary outcome was defined as anatomic success in the treated compartment at 1 year, being a POP-Q stage ≤ I, without further surgical reintervention for POP in that compartment. A priori, an alternate outcome measure was defined: leading edge of prolapse proximal to the hymen (ie, <0 cm) in the treated compartment at 1 year, without further reoperation. To address the untreated compartment, a secondary outcome was the incidence of de novo prolapse, defined as occurrence of postoperative prolapse (POP stage ≥ II) in the untreated compartment, provided there was no preoperative defect in that compartment (ie, POP stage ≤1).
Other secondary outcomes were self-completed patient-reported outcome (PRO) measures, administered at 3 months and 1 year. POP-specific symptom bother and quality of life (QoL) were measured by the short form versions of the Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7), respectively. The validated American English versions of these questionnaires were used at US sites. For use in German, Dutch, Flemish, and French languages, the American version underwent translation and cultural adaptation in accordance with the International Society of Pharmacoeconomics and Outcomes (ISPOR) guidance. To gauge patients’ subjective impression of improvement specific to the POP-intervention, the Patients Global Impression of Change (PGI-C) was used.
An internationally recognized measure of general health status, Euroquol-5D (EQ-5D), was used that enables comparisons of impact across different diseases.
For sexually active women, the short-form of Pelvic Organ Prolapse/Urinary Incontinence Sexual Function questionnaire (PISQ-12) was administered to evaluate sexual function at baseline, 3 months and 1 year. The validated English version was used at the English speaking sites, whereas the other language versions underwent the same translation and cross-cultural adaptation as described previously. Dyspareunia was assessed at baseline, 3 months, and 1 year in sexually active patients by asking “If the subject has been sexually active in the last 6 months/since the study surgery, have they experienced dyspareunia?”
Pelvic pain was evaluated during routine life and/or during pelvic examination at baseline and follow-up visits. The incidence of mesh contraction and vaginal wall stiffness was determined if pain was elicited on gentle palpation of mesh and its attachment points during pelvic examination. A predetermined safety outcome was the incidence of any exposures/erosions including location.
Sample size estimation, assuming that anatomic results of this new mesh were similar to the original polypropylene mesh, an anatomic success rate in the treated compartment of 80% stage ≤ I was realistic. With a 2-sided 95% confidence interval (CI) of 7% at least 125 subjects were needed to be enrolled. Anticipating on a dropout rate over the first year of 5%, this would ensure 118 subjects to be evaluable at 1 year.
Results are summarized as follows: mean, standard deviation (SD), minimum, median, maximum, and 95% CI for continuous data and number, percent for discrete data. Student t test was used to calculate P values where appropriate for change from baseline to 3 months and 1 year. The 95% CI for success rates were constructed using the exact binomial method (Clopper-Pearson). Analyses were performed using statistical software (SAS EG 4.1 with SAS version 9.1.3; SAS Institute, Cary, NC). A P value < .05 was considered statistically significant.
Results
One hundred twenty-eight women consented to the study. Surgery was completed in 127. Ten major protocol deviations were recorded in 9 patients: 4 patients with POP stage II were inappropriately included and in 6 patients additional prolapse procedures were performed. For analysis of the 3 months results, 9 more patients from a single center were excluded because of data collection problems that were resolved before collection of the 12-month data ( Figure 1 ). Baseline and surgical characteristics are presented in Table 1 .
| Characteristic | n (127) |
|---|---|
| Mean age, y | 63.9 (10.1) |
| Mean BMI kg/m 2 | 27.5 (3.8) |
| Median vaginal deliveries (range) | 2 (0–6) |
| Postmenopausal, n (%) | 117 (92.1) |
| Surgical history, n (%) | |
| Hysterectomy | 52 (40.9) |
| Previous POP repair | 27 (21.3) |
| Previous incontinence surgery | 9 (7.1) |
| Concomitant procedures, n (%) | |
| Hysterectomy | 21 (16.5) |
| TVT or TVT-O | 36 (28.3) |
| Perineal repair | 14 (11) |
| Additional intervention for prolapse | 6 (4.7) |
| Anesthesia type, n (%) | |
| General | 80 (63) |
| Spinal | 47 (37) |
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