Native‐tissue prolapse repair: Efficacy and adverse effects of uterosacral ligaments suspension at 10‐year follow up

Abstract Objective To evaluate the 10‐year outcomes of high uterosacral ligaments suspension as a primary repair for apical prolapse and to evaluate the long‐term impact of prognostic factors. Methods A retrospective study analyzed 10‐year follow up after repair of primary apical prolapse through high uterosacral ligament suspension. Bulging symptoms and postoperative prolapse stage II or above were considered subjective and objective recurrences, respectively. Patient Global Impression of Improvement score was used to evaluate subjective satisfaction after surgery. Results A total of 287 women were analyzed. Ten‐year recurrence rates were 19.1% for objective recurrence and 6.3% for subjective recurrence; surgical retreatment rate was 2.1%. Premenopausal status was related to 15‐fold increased risk of developing either objective or subjective recurrence. Conversely, anterior and posterior repair were protective factors against reoperation. Conclusion High uterosacral ligaments suspension is a safe and long‐lasting effective procedure for the treatment of uterovaginal prolapse even 10 years after index surgery. Premenopausal status and lack of anterior and posterior repair represented long‐term risk factors for surgical failure.

include age and other population characteristics, obstetric history, advanced prolapse stage, histologic findings, and supplementary surgical procedures performed (such as anterior or posterior repair). 3,4 Among native-tissue techniques, high uterosacral ligaments (USL) suspension is considered a valid and effective procedure for central compartment repair. Moreover, it is versatile because it can be used for primary repair, POP recurrence, and uterus-sparing surgery. [5][6][7] However, as for other native-tissue procedures, there is a lack of data about the long-term follow up in terms of objective and subjective outcomes. This is even more relevant considering population aging and limited healthcare resources.
The present study represents an update of our previously published study on the 5-year safety and efficacy of USL suspension for the primary treatment of uterovaginal prolapse. 8 We aimed to evaluate the 10-year effectiveness and functional results of high USL suspension as a technique for primary repair of apical prolapse.
Moreover, we aimed to evaluate the long-term impact of prognostic factors on outcomes.

| MATERIAL S AND ME THODS
Between October 2008 and December 2012, patients who underwent native-tissue repair of through vaginal hysterectomy followed by high USL suspension for POP in a single center were retrospectively analyzed. Patients living outside the administrative region or followed up outside the hospital at the office of a trusted gynecologist were not considered. Preoperative evaluation included a medical interview to assess obstetrical history. The presence of urinary, sexual, and bowel symptoms was defined according to International UroGynecology Association and International Continence Society standardization of terminology. 9 A urogenital examination was performed and POP was staged according to the Pelvic Organ Prolapse Quantification system (POP-Q). 10 Patients underwent transvaginal hysterectomy and salpingectomy; bilateral oophorectomy was performed-if technically feasible-according to menopausal status, age, oncologic risk, and patients' will. After vaginal hysterectomy, high USL suspension was performed with two or three monofilament absorbable size 0 sutures per side (Figure 1). 7 Additional surgical procedures, such as anterior and/or posterior repair, were performed when needed. Specifically, the anterior repair was performed through midline fascia plication with non-absorbable interrupted sutures from the level of the bladder neck to the apex of the anterior vaginal wall, and the apex of the duplicated fascia was incorporated with suspension sutures. This represented the standard procedure for POP primary repair in the case of menopausal women or premenopausal women not requiring uterine preservation during the given period. All the procedures were performed by two surgeons experienced in pelvic floor surgery. Patients were followed up 1 year after surgery and then yearly.
Patients who did not perform a visit in the last year were called by telephone and scheduled for a visit. In case of refusal, we asked for the reason. Follow-up visits included a clinical interview and a complete urogenital examination. Postoperative presence of bulging symptoms according to the specific item of the Italian version of the Prolapse Quality Of Life (P-QoL) questionnaire (answer "A little/ Moderately/A lot" to the item "Feeling a bulge/lump from or in the vagina") was considered as a subjective recurrence [112]. A postoperative descent to stage II or below according to the POP-Q system in any compartment or the need for reoperation was considered as objective recurrence. Patient Global Impression of Improvement (PGI-I) score was used to evaluate subjective satisfaction after surgery. 11 This is a seven-point scale quality of life (QoL) questionnaire evaluating patients' satisfaction with a range of responses from 1, "very much improved" to 7, "very much worse". QoL success was defined by both "very much improved" and "much improved" at PGI-I score (≤2). The study was approved by the Institutional Review Statistical analysis was performed with JMP 7.0 (SAS Institute, Cary, NC, USA). A P value less than 0.05 was considered significant.

| RE SULTS
A total of 402 records were identified. Forty-nine women living outside the administrative region or followed up outside the hospital at the office of a trusted gynecologist were not considered. As a consequence, 353 women who underwent vaginal hysterectomy and high USL suspension in the study period were evaluated. Most women had a uterovaginal prolapse stage 3 or above according to F I G U R E 1 Triple transfixion of the right uterosacral ligament POP-Q. The total complication rate was 4.0%, with ureteral kinking being the most frequent complication (2.3%). This was identified by intraoperative cystoscopy in all cases and managed with ureteral stenting or intraoperative revision of the sutures. Other complications included: hemoperitoneum (0.8%); bladder perforation (0.3%); vaginal cuff abscess (0.3%); and urinary retention requiring suburethral sling cut (0.3%). Sixty-six patients were lost at follow up (18.7%) because they were severely ill, dead from causes not related to pelvic floor surgery, or unable to be contacted. The remaining 287 patients were analyzed. The median follow-up time was 120 months (100-130 months). Population characteristics are reported in Table 1. Surgical procedures performed are shown in Table 2. Mean operative time was 100 min (85-120 min) and blood loss was 250 ml (150-300 ml). Long-term outcomes are reported in Table 3. Overall, anatomic recurrence at 10 years was found in 55 (19.1%) patients. The anterior compartment was the site with the highest rate of recurrence (45 patients; 15.7%), followed by the posterior (19 patients; 6.6%) and the central (7 patients; 2.5%) compartments. Symptoms of prolapse were reported by 18 (6.3%) patients, and surgical retreatment for prolapse recurrence was required by only 6 (2.1%) women. None chose/required pessary use.
Comparison between preoperative and 10-year postoperative vaginal profile according to the POP-Q system is shown in Table 4. We noted a persistent improvement in all POP-Q points at the 10-year time point compared with the preoperative assessment, with the exception of total vaginal length, which was shorter after surgery (10.3 vs. 8.7 cm; P < 0.001). Even in the long term, native-tissue prolapse repair did not result in any detrimental effect on functional outcomes (Table 5). Notably, a persistent positive impact was observed-besides bulging symptoms-on stress incontinence and voiding symptoms rates (P < 0.001). Multivariate analysis demonstrated a significant impact of considered risk factors on long-term outcomes (Table 6). Specifically, premenopausal status involved a 15-fold risk of developing either objective or subjective recurrence.
Moreover, anterior and posterior repair at the time of prolapse surgery was protective against reoperation for prolapse (odds ratios 0.06 and 0.13, respectively).

| DISCUSS ION
Long-term outcomes of reconstructive pelvic surgery are not well known, which can be relevant when considering native-tissue repair, in which the recurrence rate is supposed to be unsatisfactory.
The present study reports the combination of subjective, objective, functional, and QoL outcomes of USL suspension for the treatment of uterovaginal prolapse at 10-year follow up. This represents-to the best of our knowledge-the first work evaluating the outcomes most often involved (12.8%). Symptoms of prolapse were reported by 9.4% of women and 1.5% required reoperation for prolapse recurrence. Similarly, Duan et al. 14 retrospectively analyzed a cohort of 104 patients 9 years after USL suspension and reported a 91% cure rate (no prolapse beyond the hymen, symptoms of prolapse, or reoperation/pessary use). The anterior compartment was most affected by POP recurrence beyond the hymen (6.7%), followed by the posterior compartment (2.9%).
The pattern of recurrence after USL suspension described in these papers were reproducible and consistent with our series. The anterior compartment was confirmed to be the most frequent site of recurrence, whereas apical relapse was unlikely to occur after USL suspension. Similar to our data, it was a general finding that most women with anatomic recurrences are not symptomatic, and few of them require reoperation. This might indicate that even when recurrence is associated with bulging symptoms, they may be mild and only minimally affect quality of life. Excellent PGI-I scores in our cohort of patients seem to confirm this hypothesis.
As a consequence, according to our data and previous reports, it is reasonable to consider high USL suspension an effective procedure for anatomic restoration and symptom relief even in the long term. Ureteral injuries represent a feared complication of this procedure and may act as a deterrent to its popularization for clinical use. According to the meta-analysis by Margulies et al., 19 this complication may occur in up to 11% of procedures. However, the mean rate was estimated to be 1.8%, which is consistent with our data.
Moreover, diagnostic cystoscopy with contrast dye allows early identification and intraoperative management, thus reducing longterm sequelae. Recently, intraoperative power Doppler ultrasound has been proposed as a non-invasive method to evaluate ureteral patency during pelvic surgery. 20 As most ureteral obstructions can be resolved with the removal of the offending uterosacral suspension suture(s), the need to perform ureteral implantation to recover from ureteral injury is estimated to be only 0.6%. 19 Although a short-term positive impact on urinary, bowel, and sexual function after native-tissue repair with the USL is well established, data on long-term functional outcomes are scarce. 1 This is particularly relevant, considering that aging is directly related to the prevalence of pelvic floor disorders, such as urinary incontinence, overactive bladder, constipation, and sexual inactivity. 21  In our previous work, we demonstrated that anterior repair was a protective factor for anatomical recurrence of stage 2 or more associated with bulging symptoms (P = 0.002). 8 Similarly, Chen et al. 22 found that a suboptimal correction of anatomic defects-defined as the immediate postoperative finding of apical prolapse of at least stage-was a significant risk factor for surgical failure. 22 In this series, despite the relatively high rates of anterior and posterior repair (respectively, 89.2% and 74.6%), the lack of additional procedure represented a significant risk factor for reoperation. This may indicate that a certain grade of pelvic floor damage is probably widespread in all vaginal compartments and intraoperative recognition somehow underestimates defects.
On the contrary, the role of premenopausal status as a risk factor for recurrence may at first seem contradictory, because menopause and increasing age are well-established risk factors for prolapse development. However, prolapse development in young fertile women might indicate a greater grade of pelvic floor damage and/or a poorer connective tissue quality. This hypothesis is consistent with the observation of histologic alteration in the connective tissue of the vesico-vaginal fascia of patients with POP recurrence compared with controls. 4 Moreover, previous studies have reported a higher risk of POP recurrence in younger patients using different cut-offs. [23][24][25] To our knowledge, this is the first study analyzing 10-year outcomes after native-tissue repair for uterovaginal prolapse. Strengths of our study include the long follow up, homogeneous and large population, multimodal evaluation of surgical success, and analysis of risk factor impact. A limitation is the retrospective study design.
Another limitation is the loss at follow up, which may also include patients with a recurrence who seek help at another institution, so underestimating the failure rate. However, our loss rate was consistent with those of previous similar works.
In conclusion, our study demonstrated that native tissue repair through high USL suspension is a safe and effective procedure for the treatment of uterovaginal prolapse, with long-lasting effectiveness over time and persistence of functional benefits even 10 years after the index surgery. Premenopausal status and lack of anterior and posterior repair represented long-term risk factors for recurrences.