Insertion of an Anterior Transobturator Mesh Kit in the Management of Recurrent Anterior Vaginal Wall Prolapse
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- Dmochowski, R.R. Curr Bladder Dysfunct Rep (2011) 6: 111. doi:10.1007/s11884-011-0095-6
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Trial: Fayyad AM, North C, Reid FM, Smith ARB. Prospective study of anterior transobturator mesh kit (Prolift™) for the management of recurrent anterior vaginal wall prolapse. Int Urogynecol J Pelvic Floor Dysfunct 2011; 22(2):157–63.
Rating: •Of importance.
Keywords Anterior transobturator mesh kit · Anterior vaginal wall prolapse · Anatomic outcomes · Functional outcomes · Defects · Cystocele · Prolapse · Surgery · Vaginal bulge · Vaginal fullness · Mesh exposure · Voiding dysfunction · Urgency · Incontinence
Introduction: This study assessed the anatomic and functional outcomes of one type of mesh kit inserted for the correction of anterior compartment vaginal prolapse (cystocele) in a controlled fashion, using physical examination and standardized assessment of symptomatic (functional) outcomes.
Aims: This study was designed to assess in a prospective, observational design the subchronic outcomes of the insertion of a specific type of anterior compartment mesh kit repair (Prolift; Ethicon, Somerville, NJ) in women diagnosed with a symptomatic cystocele. All study participants had previously had an anterior vaginal prolapse repair that had failed anatomically and that was associated with bothersome symptoms.
Methods: The participants were evaluated and treated at a tertiary referral institution in northern England. Thirty-six women were identified over a 1-year period and subsequently underwent mesh kit insertion by standard method. The authors reported meticulous technique for the surgical incisions and creation of dissection planes. All participants underwent a preoperative assessment inclusive of physical examination with anatomic staging using the Pelvic Organ Prolapse quantification (POP-Q) instrument, and symptom appraisal using the Prolapse Quality-of-Life Questionnaire and Prolapse and Incontinence Sexual Function Questionnaire Short Form (PISQ-12). Repeat assessment was accomplished at 6 months and 2 years using these same methods with the addition of the Global Impression of Improvement Questionnaire. General quality of life was also evaluated at follow-up. The authors defined surgical anatomic success as less than or equal to stage I anterior compartment prolapse. A variety of safety outcomes were also reported, including mesh exposure rates and need for repeat surgical intervention.
Results: Prior to surgical intervention, 34 of the 36 patients had stage II or greater anatomic defects. They were observed for a mean of 24.6 months (range, 23–26.5 months). Anatomic outcomes as defined by POP-Q stage included 19 of 36 (53%) with stage I or less anterior prolapse, 15 of 36 (42%) with stage II prolapse, and 2 of 36 (5%) with stage III prolapse. A total of 29 of 36 (80.5%) experienced subjective improvement in prolapse symptoms (sensation of bulge or perineal mass effect) on symptom metric assessment, although 12 still complained of a vaginal bulge (9 with anatomic prolapse at or beyond the hymen). Voiding dysfunction after surgery was manifest in five women (de novo stress incontinence). An additional four women experienced a deterioration (worsening) of preexistent stress incontinence. Of the 14 women with preoperative urgency and/or urgency incontinence, 6 were improved, with no patient experiencing deterioration in these symptoms. Urinary obstructive or postmicturition disorder improved after surgery in 6 of the 14 who had these symptoms prior to surgery.
Dyspareunia occurred in 7 of the 16 patients who were sexually active prior to surgery. Seven of 36 patients (18%) developed vaginal mesh exposure, with 5 requiring surgical revision for symptoms associated with the exposure. The median time to mesh exposure from index surgery was 9 months. The authors did not comment on defecatory dysfunction before or after surgery.
Discussion: The dissonance between the anatomy of prolapse and the associated bothersome symptoms that are associated with this condition has been heretofore not adequately defined or reported. Recently, this dysjunction has been become a focal point of outcomes reporting for vaginal prolapse interventions. This study highlights the poor correlation between functional outcomes and anatomic findings. Although anatomic success (as prospectively defined) was achieved in slightly more than 50% of the study population, issues related to persistent symptoms were present in some patients and, additionally, mesh exposure rates of 18% were problematic and required reintervention is some women. The authors underscored the complexities of management of recurrent prolapse and the persistent issues of durability of surgical repairs in the context of pre- and postsurgical bladder and sexual function. Urinary symptoms are clearly associated with the condition of anterior compartment prolapse and the interventions undertaken for this condition. This study presents a very good assessment of urinary function across all domains of urinary function (storage, emptying, and postmicturition) and is exemplary for others considering this domain of outcomes assessment.
Pelvic organ prolapse is a condition complicated by measurable anatomic defects that may or may not be associated with symptomatic correlates. The historical evidence that reports the sequelae of surgical intervention for pelvic organ prolapse is deficient in functional outcomes reporting. Anatomic changes, and durability of same, have provided the mainstay of this evidence. Over the past decade, standardized tools for evaluating symptoms concomitant with anatomic prolapse have arisen. These metrics have evolved and matured as methods to evaluate and capture change in associated prolapse and urinary and bowel symptoms. Most recently, a delayed recognition of the sexual dysfunction associated with pelvic organ prolapse also has emerged, and tools for capturing the same have been developed. Additionally, the recognition that anatomy and symptoms are not completely linked also has been demonstrated in many reports. This paper adds important incremental knowledge regarding this condition, confirming that not every prolapse defect is universally correctable or without associated potential onus regarding persistent or de novo functional symptoms. Also, this paper correctly identifies the conundrum of mesh compartment repairs: the potential of durability as opposed to the risk of need for reintervention and associated symptoms. Several large, randomized controlled trial analyses of trocar-based mesh kits have been published recently. Altman et al.  recently presented a Scandinavian experience with anterior mesh compared with standard anterior colporrhaphy and noted that although anatomic success was greater in the mesh group, so were complications and the need for surgical reintervention. Carey et al.  also reported on a randomized controlled trial conducted in the United Kingdom that demonstrated no benefit to the use of mesh for anatomic outcomes but also showed no difference between mesh and no mesh for dyspareunia and other functional outcomes. Nguyen and Burchette  found similar outcomes between colporrhaphy and mesh implantation, with no differences between overall anatomic and functional outcomes between groups, and a mesh exposure rate of 5%. The most recent Cochrane assessment of prolapse surgical outcomes concluded that anatomic success is higher with mesh grafts, but that other outcomes remain to be fully understood . Clearly, more research needs to be conducted to help us better understand the relationship between interventions and outcomes, most certainly from the predictive standpoint.
From a patient-centric standpoint, the recently appreciated functional outcomes of prolapse interventions are critical to approbation—or lack thereof—for any intervention. As noted in this report, the preoperative identification of these symptoms and a focused assessment after intervention are critical to understanding fully the implications of these interventions, whether or not anatomic restoration has occurred. The potential for complication related to implantation of mesh adds another variable to consider, given that reintervention for these issues may compound symptomatic dissatisfaction. Despite the fact that a control arm is not present, important issues about outcomes are raised by this paper.
As Barber and colleagues  recently noted, women most often associate success resulting from prolapse surgery not with anatomic success but with resolution of the vaginal fullness (“bulge”). It would be reasonable to construe that any potential positive benefit of bulge resolution may be negated or minimized by the need for surgical reintervention or de novo functional problems. Clearly, informed consent must include the anatomy and symptoms and the potential for persistence, exacerbation, or development of new symptoms related to interventions for prolapse.
Dr. Dmochowski has served as a consultant for Merck & Co., Johnson & Johnson, Medtronic, and Pfizer.