Instruments and TechniquesA Prospective Study to Evaluate the Anatomic and Functional Outcome of a Transobturator Mesh Kit (Prolift Anterior) for Symptomatic Cystocele Repair
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Study Design, Material, and Methods
Consecutive patients treated with the Prolift Anterior Repair System (Ethicon) between May 2005 and October 2006 in Hospital Oost-Limburg in Genk, Belgium, were prospectively followed up in this study. During the study period, all patients undergoing surgery for symptomatic stage 2 (ICS [12]) or more anterior vaginal wall prolapse underwent an operation with a transobturator anterior vaginal mesh kit. Anterior colporrhaphy was performed instead of Prolift Anterior in case concomitant
Surgical Procedure
Gynecare Prolift is a low-weight (42.7 g/m2), 0.42-mm–thin, monofilamentary, and macroporous polypropylene prosthesis. The transobturator anterior vaginal wall mesh was inserted according to a standardized surgical protocol as described by Reisenauer et al [13]. In case of substantial concomitant middle compartment prolapse (defined as point C≥ -1 but C>Ba), a Prolift Posterior procedure was simultaneously performed. This posterior translevator mesh kit is based on the Posterior IVS principle
Outcome Measurements
Anatomic and functional outcome were selected as primary outcome measurements. A Pelvic Organ Prolapse Quantification (POP-Q) score to quantify the anatomic parameters of the prolapse was performed before and after surgery [12]. POP-Q is a scoring system with proven interobserver and intraobserver reproducibility that quantifies 9 points [17]. Patients were assessed clinically at 2, 6, 12, and 24 months after surgery.
Patients completed the King's College Health Questionnaire (KCHQ) before and
Statistical Analysis
Anatomic (POP-Q) and functional (KCHQ) outcome measurements before and after surgery were compared. A Wilcoxon signed-rank test was used to compare POP-Q findings before and after surgery. Repeated measurement analysis was performed to study the changes in POP-Q score over the total follow-up time. To facilitate interpretation of results, we dichotomized the answers to the questions of the KCHQ to “not present” being attributed to “no or a little” and “present” to “moderately or a lot.”
Results
During the study period 48 patients were included. Patient characteristics are shown in Table 1. The median follow-up time to assess anatomic and functional outcome was respectively 7 (range 2–24) and 14 months (range 6–23).
Primary Outcome: Anatomic Results
In Table 2, the findings at pelvic examination before and after surgery are shown. There were no statistically significant differences in the findings at pelvic examination during the last visit and the visit at 6 weeks after surgery. In patients who underwent a combined Prolift Anterior and Posterior repair, a significant improvement was observed for all compartments. In patients undergoing an anterior transobturator mesh procedure only, this improvement was statistically significant only for
Primary Outcome: Functional Results
In Table 3, responses to the KCHQ before and after surgery are shown. The responses of 6 patients are missing because they could not be reached for follow-up. The feeling of prolapse disappeared in all but 1 patient. Stress incontinence developed de novo in 13% (4/30) of patients. Stress incontinence was present in 12 patients prior to surgery and persisted in 3 (25%). In 7 of the 12 patients with preoperatively proven, symptomatic urodynamic stress incontinence, a tension-free vaginal
Secondary Outcome: Surgical Parameters and Surgery-Related Complications
The median operating time for placement of the transobturator mesh was 58 minutes (range 40–85 minutes). During surgery the patient lost a median of 140 mL blood (range 75–300 mL). The median hospital stay was 5 days (range 4–7 days).
Two (4.1%) perioperative complications and 7 (14.6%) postoperative complications were encountered. A bladder perforation during surgery occurred in 2 patients. No other complications were encountered during surgery. Two patients were treated for positive urine
Discussion
This is the first published prospective study in the PubMed database evaluating Prolift Anterior that reports on both anatomic and functional outcomes. Anatomic cure was realized in 95.8% (46/48) of the patients and functional cure in 95.2% (40/42) of the patients.
Our study is strengthened by the single-center setting, which guarantees a unified surgical technique and consistent outcome evaluation. Furthermore, the combination of anatomic and functional outcome measurements provides highly
Conclusion
The Prolift Anterior system seems to provide a valuable surgical alternative to treat anterior vaginal wall prolapse with both favorable anatomic and functional outcomes. The postoperative complication rate is 14.6%; 6.3% of patients required reintervention because of mesh-related complications. Patients deserve extensive counseling of what is known and not known about available new surgical techniques. The results of this study help to improve the quality of this counseling. Comparative
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The authors have no commercial, proprietary, or financial interest in the products or companies described in this article.