Hypothesis / aims of study
Since some years, specially, after the well-known FDA alerts, the use of synthetic mesh inlays or biological grafts against standard repair with native tissue (NT) has caused a lot of controversy and raised enquires about safety and efficacy of these techniques1.Because of this, a renewed interest has emerged about the reconstructive surgery of pelvic organ prolapse (POP) using NT. In contrast with previous publications -which reported high rates of recurrence and reoperation – more recent investigations do not find differences between NT repair and repair augmented with synthetic mesh although risk factors for recurrence need to be clarified. For example, some authors have described the role of the apical support in the posterior and anterior vaginal prolapse2 or the need for apical support at the time of an anterior repair3.
Our objective was to evaluate the efficacy of NT repair as treatment of POP affecting anterior and/or posterior vaginal compartment and to define if there are risk factors associated with POP recurrence
Study design, materials and methods
Longitudinal, prospective, unicentric, open study including women surgically treated of POP affecting anterior and/or posterior vaginal compartment NT repair and/or simultaneously treated of stress urinary incontinence (SUI) using suburethral sling. Women surgically treated of apical POP were excluded. In all cases the procedure was the primary surgery (anterior and/or posterior colporrhaphy plus suburethral sling insertion as needed). Our study was carried out from January 2012 to December 2017. Evaluations were performed basally and at one and six months, and at one and two years after surgery. Anatomic POP recurrences were defined if, at any of the examinations, POP ≥ II, according Baden-Walker classification, was found. Symptomatic POP recurrences were diagnosed if the women have any symptom of POP after surgery and/or answered positively to the question “Do you usually have a sensation of bulging or protrusion from the vaginal area?”, a Pelvic Floor Disease Inventory Questionnaire (PFDI)-based question because the ability to see or feel a vaginal bulge is the symptom most consistently related to the presence or absence of POP.
All outcomes measures were presented as summaries of descriptive statistics (mean [SD] for continuous measures and proportions for ordinal and dichotomous measures) and comparisons between groups were analysed using T-Student and χ2 when needed. Also ordinal logistic and multinomial regression were used according to the characteristics of the variables and/or because the type of association required. STATA 14 has been used.
Results
Between January 2012 and December 2017, 889 surgical procedures were performed at our Urogynecology Unit. Among these, surgical repair of POP with native tissue has been accomplished in 559 patients (62.9%). After applying inclusion criteria, 297 patients were eligible. 113 to which anterior and/or posterior vaginal compartment NT repair was the only procedure performed; and 184 patients in which in addition to the NT repair, stress urinary incontinence was simultaneously treated by placing a suburethral sling. Demographics and data about the patient characteristics can be found in the graphics and tables attached.
Considering the symptoms observed, 145 patients (49.0%) consulted for "feeling of bulge", 71 (24.0%) for bulge and urinary incontinence and 76 (26.0%) only for incontinence. The prevalence of symptoms such as urgency, frequency and nocturia was 43.1%, 33.3% and 52.5%, respectively. After careful examination, 75 (25.2%) patients were diagnosed with anterior compartment prolapse, 33 (11.1%) posterior compartment, and 192 (64.6%) of both compartments. 67 (22.6%) patients also had apical prolapse grade I that was not corrected. SUI was found in 118 (39.7%) and mixed urinary incontinence (MUI) with predominance of the stress component in 84 (28.3%).
Regarding surgery, 99 (33.3%) anterior, 52 (17.5%) posterior and 146 (49.2%) anterior and posterior colporraphies were performed. A TOT suburethral sling was placed in 105 (58.7%) patients, TVT in 34 (18.7%), Needleless in 13 (7.1%) and a Reemex device in 29 (15.5%) patients. Bladder perforation was observed as the unique intraoperative complication and it happened in 6 patients (2%), all of them in the group that had undergone sling placement. During the immediate postoperative period, 19 (7.1%) complications were noticed, 14 of them (76.2%) occurred in patients who had undergone SUI surgery (12 of them presented acute urinary retention, requiring urethrolysis in two cases, and 2 suffered pain that required mesh burial. 5 (4.0%) patients needed reitervention, 3 of them due to complications associated with the sling (urinary obstruction, pain ...) that required surgical removal and 2 due to symptomatic prolapse recurrence that required a new prolapsed operation during the first year of follow-up.
Interpretation of results
No significant differences were found between groups when comparing need of reinterventions. Regarding follow-up and recurrence, at the end of one year,193 records were obtained. The overall successful procedure (POP<II) rate was 87%(n=168). A 9.8% (n=19) of anatomical prolapsed recurrence and a 3.1%(n = 6) of symptomatic prolapsed recurrence were observed. After two years of follow-up, the anatomical recurrence and the symptomatic recurrence rate were 6.9% and 3.1% respectively. We found 29 (9.7%) prolapsed recurrences. 79.3% (23/29) in the same compartment and 20.7% (6/29) in a different one. The group of patients without recurrence has been compared with both, patients with anatomic and patients with symptomatic recurrence according to variables such as age, BMI, parity, exposure to physical activity, degree of prolapse, suburethral sling insertion and the presence of apical prolapse not corrected at the time of intervention. No significant differences have been found. See table 1 and 2.