Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse

Abstract

Background: The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy. Methods: In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocarguided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery. Results: Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P < 0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P = 0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P = 0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group. Conclusions: As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials. gov number, NCT00566917.).

Medium-term clinical outcomes following surgical repair for vaginal prolapse with tension-free mesh and vaginal support device

“…When these results are compared to those from other multi-center studies, using the strict criteria of anatomic success (POP-Q stage 0-I), these medium-term results (69%) do appear to be lower than the 1 year results reported by Withagen et al (90%) and Altman et al (82%) [6,8]. However, as the duration of follow-up in these studies are significantly shorter than those of our study, direct comparison of results is not possible, and thus the difference in anatomic success between the studies should be interpreted with caution.…”

“…Further to this, the sustained symptom improvements observed over time following this repair is consistent with the suggestion that some degree of vaginal relaxation or pliability is desirable for normal pelvic floor functioning. Another consideration was the reduce rate of de novo stress urinary incontinence following this repair (5%), compared to those reported from the studies of Withagen et al (10%) and Altman et al (12%) [6,8]. A properly controlled and adequately powered study would need to address the overall risk-benefit profile between different mesh kits.…”

“…Synthetic implants were introduced in an attempt to obtain more durable results, and mesh has been demonstrated to provide improved anatomic outcomes when compared to colporrhaphy at 1 year [6,7]. Use of standardized transvaginal mesh kit resulted in significantly higher rates of anatomic and symptomatic success compared to traditional colporrhaphy for repair of the anterior wall prolapse in a recently reported comparative study [8]. However, the placement of vaginal mesh is associated with higher rates of adverse events [9,10].…”

Subjective and objective results of anterior vaginal wall repair in an outpatient clinic: a 5-year follow-up

“…A multicenter randomized controlled trial comparing outcomes in traditional colporrhaphy and a trocar-guided transvaginal polypropylene mesh kit in women with anterior vaginal wall prolapse has recently been published [15]. Three hundred and eighty-nine women participated.…”

Urogynäkologie, „overactive bladder“ und Neurourologie

“…Bei vernünftiger Indikation und entsprechender operativer Erfahrung bieten die Netze objektiv und auch subjektiv dauerhaft gute Langzeitergebnisse [3] und zeigen randomisiert gegen die klassische vordere Kolporrhaphie bessere Langzeitergebnisse, wenngleich die Kurz-und Langzeitkomplikationsraten der Kunststoffimplantate höher lag [4]. Die oft sehr unkritische Verwendung dieser Netze und von der Industrie getriebene weite Verbreitung, auch bei nicht sehr erfahrenen Operateuren, führte zumindest in den USA 2008 zur Empfehlung seitens der FDA, dass diese Netze aufgrund hoher Komplikationsraten nur bei Rezidiveingriffen indiziert seien.…”