Abstract
Objective
To determine the objective and subjective outcomes of a Combined anterior trans-obturator mesh (Surelift-A) and sacrospinous ligament fixation (SSF) for advanced pelvic organ prolapse (POP), along with the evaluation of surgical complications, postoperative impact on quality of life (QoL), and lower urinary tract symptoms.
Methods
Retrospective cohort study in a tertiary center from May 2021–December 2022 included 150 patients with symptomatic anterior or apical POP stage III and IV, who underwent pelvic reconstructive surgery with Surelift-A mesh combined with SSF. All completed a 72-h voiding diary, urodynamic study (UDS), and multiple validated QoL questionnaires at baseline, 6 and 12 months postoperatively. Primary outcomes were the development of post operative de novo stress urinary incontinence (SUI), objectively via cough stress test and UDS, and subjectively by evaluation of UDI-6, question 3 score >1 and IIQ-7, QoL and surgical complications. Secondary outcomes were the objective cure of POP, defined as anterior and apical prolapse Pelvic Organ Prolapse Quantification System ≤ stage I, and subjective cure based on negative answers to Pelvic Organ Prolapse Distress Inventory 6, quality of life, sexual function, major and minor complications.
Result
At one-year follow-up, the objective cure rate was 96.7 %, whereas the subjective cure rate was 93.3 %, with favorable anatomical outcomes. Significant QoL improvements were observed. Among those without mid-urethral sling (MUS), a (60.0 %) improvement in SUI occurred. De novo SUI emerged in 10.5 % objectively and 12 % subjectively. Mesh exposure rate was 1.3 %.
Conclusion
The Combined Surelift-A and SSF approach shows effective cure rates with minimal complications, and a slight risk of de novo SUI.
Introduction
Pelvic organs prolapse (POP) is a complex condition requiring comprehensive surgical intervention, particularly in cases involving all three compartments. The fixation of the apex, a crucial component of pelvic reconstructive surgery (PRS), with sacrospinous ligament fixation (SSF) leaves patients vulnerable to future cystocele recurrences due to shift in vaginal axis towards a horizontal orientation, that necessitates preventive measures at the anterior compartment, with mesh emerging as a viable option [ ].
Various techniques for anterior-apical transvaginal mesh (TVM) surgeries have been explored. While procedures like para-vesical space open anterior-apical TVM, such as the Elevate A® system (Elevate Anterior and Apical Prolapse Repair System, American Medical Systems, Minnetonka, MN) [ ] and Uphold™ LITE Vaginal Support System (Boston Scientific, Marlborough, MA, USA) [ ] showed good outcomes in curing POP, they came with an increased risk of de novo or persistent stress urinary incontinence (SUI) and urge urinary incontinence (USI) [ ]. On the other hand, techniques such as para-vesical space not-open anterior TVM (e.g., Perigee™ system, American Medical Systems, Minnetonka, MN, USA) [ ] and AvaultaPlus™ Anterior system (C.R. Bard, Inc., Murray Hill, NJ, USA) [ ] exhibited good cure rates with lower incidences of de novo or persistent SUI. However, in such cases, a concurrent apical support procedure like sacrospinous ligament fixation (SSF) is often required.
The Surelift® device (Neomedic International, Barcelona, Spain), a current option for advanced POP TVM surgery, presents a unique design with proximal, middle, and distal arms. The author proposes that adopting a specific approach, called Surelift-A which utilizes the distal and middle arms (proximal arms excised) in a trans-obturator manner, thus avoid opening the para-vesical space, in combination with SSF for apex suspension. This configuration will provide a high cure rate for prolapse and reduces de novo stress urinary incontinence.
The primary objective of this research is to evaluate the incidence of de novo or persistent SUI in women undergoing extensive pelvic organ reconstruction surgery with anterior mesh (Surelift-A) and SSF. Secondary outcomes encompass POP recurrence, quality of life, sexual function, major and minor complications.
Materials and methods
This retrospective study was approved by Tertiary Center Review Board (IRB: 202400606B0). From 2021/5–2022/12, all patients attending the urogynecology clinic for complaints of POP were screened for eligibility. Those with symptomatic anterior and apical prolapse stage III and IV, according to the Pelvic Organ Prolapse Quantification System (POP-Q), and underwent surgical intervention using the Surelift-A mesh were included in the study. The exclusion criteria included patients with previous radical pelvic surgeries, prior mesh surgeries for prolapse, and those with medical conditions who were unfit for transvaginal surgery.
Patients adhered to a standardized institutional protocol both before and after surgery. Before the procedure, all patients underwent comprehensive preoperative assessments, including a detailed medical history, physical examination (which involved a pelvic examination and a cough stress test), urinalysis, 1-h pad test, 72-h voiding diary, and multichannel urodynamic study (UDS) with their prolapse reduced through ring pessaries. Additionally, at baseline and between 6 and 12 month postoperative follow-up, patients completed various validated Chinese versions of quality of life questionnaires [ ], such as the Urogenital Distress Inventory 6 (UDI-6), Incontinence Impact Questionnaire 7 (IIQ-7), Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), Colorectal-Anal Distress Inventory 8 (CRADI-8), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ-12). All conditions were defined according to the International Continence Society (ICS) [ ]. Patients were counseled on surgical procedures and alternatives, including the use of vaginal pessaries, uterine preservation versus concomitant hysterectomy, and the potential benefits and risks. Discussion on intra- and postoperative complications, including those related to mesh, as well as the possibility of prolapse recurrence, de novo stress urinary incontinence (SUI), and the need for additional procedures, were made. Preoperatively, anesthetists and physicians addressed medical comorbidities, requiring a glycated hemoglobin level of 6.5 % or below for the preceding 3 months. Patients who demonstrated urodynamic stress incontinence (USI) during their preoperative workup were advised to the option of a concomitant incontinence procedure.
Operative procedure
The study used a modified version of the Standard Surelift system (Neomedic International, Barcelona, Spain), known as Surelift-A ( Fig. 1 ). The surgical approach involved careful hydro dissection into the vesicovaginal space, single incision at the anterior vaginal wall and careful dissection without manipulating the para-vesical space. Electrosurgery was not used in order to minimize tissue necrosis risk. The mesh application was standardized, including tagging the mesh’s distal tip beneath the bladder neck to prevent cystocele recurrence. Both distal arms were retained, passed through the obturator foramens, and the anterior vaginal wall was closed with interrupted sutures. The apical portion fixation to the sacrospinous ligament was done in a conventional approach via the posterior route. It included hydro dissection, sharp and blunt dissection to the rectovaginal space. For rectovaginal space access, the descending rectal septum was perforated, opening the right pararectal space. If needed, the left pararectal space was accessed, and the left sacrospinous–coccygeal complex identified. Non-absorbable sutures were placed on the sacrospinous–coccygeal complex using the Anchorsure® applicator provided in the Surelift system, tied, and passed through the apical vaginal wall. After tying, the vault or cervix was lifted cephalad, and the posterior vaginal wall closed.
Concomitant vaginal hysterectomy (VH), posterior colporrhaphy and trans obturator Mid-urethral Sling (MUS) were performed if required. all surgical procedures were performed by the same senior author (TSL) with the patient’s consent. All patients received prophylactic intravenous cefazolin 500 mg at least 30 min before the first cut and every 6 h for 24 h.
A cystoscopy was done at the end of the surgery to assess bladder integrity. Postoperatively, a Foley catheter and a povidone-iodine−soaked vaginal pack was placed for 1 day. After removal of the urinary catheter, the postvoid residual urine (PVR) volume was accessed using a bladder scanner. Patients were discharged if the PVR volume was ≤150 ml. In case where the PVR volume was persistently >150 ml for more than 5 days, the patients were taught clean, intermittent self-catheterization. Outpatient follow-up visits were scheduled at 1 week, 1 month, 3 months, 6 months, 12 months, and 1 year postoperatively. During each visit, the patients were evaluated both subjectively and objectively with pelvic examination and POP-Q assessments. UDS, 1-h pad test, and QOL questionnaires were administered between 6 and 12 months postoperatively. In case of de novo USI the options of either conservative management or surgical intervention were discussed with the patient. A credentialed nurse made telephone follow-ups to patients unable to participate in the clinic follow-ups.
Outcome measure
Primary outcome was the occurrence of postoperative de novo SUI, evaluated objectively via cough stress test and UDS, and subjectively by evaluation of UDI-6, question 3 score >1 and IIQ-7. Secondary outcomes measures were POP recurrence, QoL sexual function and major and minor complications. POP cure was defined as POP-Q ≤1 at the anterior vaginal wall and all its compartments.
Statistical analysis
A post hoc sample size of 76 subjects was needed to detect de novo urinary leak of 15 %, with a 95 % confidence interval and statistical power of 80 %. Descriptive statistics were used for demographics and perioperative data. The paired-samples t-test and the McNemar test were applied for comparison of pre- and postoperative continuous and categorical data, respectively. The distribution-based approach uses the effect size (ES) index to relate clinically meaningful change. The minimal major difference was calculated as the standard deviation (SD) = 0.2 (small ES), SD = 0.5 (medium ES), and SD ≥ 0.8 (large ES) of baseline scoring [ ]. Values of p < 00.05 were considered statistically significant for all comparisons. All statistical analyses were performed using SPSS version 17 (IBM Corp., Armonk, NY).
Results
160 women were included in the initial cohort. 10 patients were excluded from the study because of incomplete data leaving 150 patients for final analysis ( Fig. 2 ).
The demographic data and surgical outcomes of our patients are shown in Table 1 . The mean age was 63.1 years (Range: 60.1–66.0), with most patients (87.3 %) being postmenopausal. 16.0 % (n = 24/150) had had previous hysterectomies, and 23.3 % had preexisting diabetes mellitus (DM). The median period of follow-up was 45.8 months (Range: 45.2–46.3). 87 cases had VH and 51 of them (58.6 %) had concurrent MUS. Out of the 63 cases without VH Procedures 37 cases (58.7 %) had MUS.
| Mean age (year) | 63.1 ± 8.7 | (60.1–66.0) |
|---|---|---|
| Median parity (range) | 3.0 | (1–6) |
| Mean BMI (kg/m 2 ) | 24.0 ± 2.4 | (23.2–24.8) |
| Postmenopausal | 131 | 87.3 % |
| Hormone therapy, topical | 120 | 80.0 % |
| Medical co-morbidities | ||
| Diabetes mellitus | 35 | 23.3 % |
| Hypertension | 60 | 40.0 % |
| Cardiovascular diseases | 6 | 4.0 % |
| Parkinson’s Disease | 0 | 0 % |
| Breast cancer | 3 | 2.0 % |
| Asthma | 2 | 1.3 % |
| Stroke | 1 | 0.7 % |
| Myasthenia gravis | 1 | 0.7 % |
| Prior pelvic surgery | 24 | 16.0 % |
| VH | 5 | |
| AH/sAH | 12/2 | |
| LH | 5 | |
| Mean operating time (min) | 71.7 ± 11.4 | (67.8–75.5) |
| Mean intraoperative blood loss (ml) | 72.2 ± 49.9 | (53.3–890.1) |
| Mean hemoglobin difference (g/dl) | −1.4 ± 0.9 | (-1.7–1.1) |
| Mean hospital stay (days) | 3.0 ± 0.1 | (3.0–3.0) |
| Median period of follow-up (months) | 45.8 ± 2.6 | (45.2–46.3) |
| Concurrent surgery | ||
| SS + A-P/(with MUS, without MUS) | 63 | 42.0 % |
| VH + SS + A-P/(with MUS, without MUS) | 87 | 58.0 % |
| Complications, major | ||
| Oran injury | 0 | 0 % |
| Complications, minor | ||
| Mesh exposure, vagina | 2 | 1.3 % |
| Infection | 0 | 0 % |
| Hb difference >2 g/dL | 18 | 12.0 % |
| Anemia with transfusion | 1 | 0.7 % |
| Buttock pain, medication required | 1 | 0.7 % |
| Secondary surgery | ||
| MUS/TOT or SIS sling | 0 | 0 % |
| Prolapse surgery | 0 | 0 % |
| Objective cure at 1 year, n (%) | 146/150 | 96.7 % |
| Anterior | 147/150 | 98.0 % |
| Apex | 149/150 | 99.3 % |
| Posterior | 146/150 | 96.7 % |
| Subjective cure at 1 year, n (%) | 140/150 | 93.3 % |
No major complications or organ injuries were observed. However, we noticed22 cases of minor complications: 18 cases (12.0 %) of Hemoglobin (Hb) Difference >2 g/dL, 1 case (0.7 %) of Anemia with blood transfusion, and 1 case (0.7 %) of Buttock pain requiring medication. Two cases (1.3 %) of Mesh Exposure were diagnosed on the basis of symptomatology and pelvic examination, and classified according to the Joint International Urogynecological Association/ICS Working Group on Complications Terminology [ ].
At the 1-year follow-up, high cure rates for pelvic floor disorders were observed, with an overall objective cure rate of 96.7 %. Specific anatomical sites exhibited impressive outcomes, including 98.0 % for the anterior compartment, 99.3 % for the apex, and 96.7 % for the posterior compartment. Additionally, the subjective cure rate was 93.3 %. None of the patients were sufficiently symptomatic to require further reparative surgery ( Fig. 3 ).
Among 93 patients with USI, those with MUS had high objective and subjective cure rates: 90.9 % and 88.6 %, respectively. MUS demonstrated higher efficacy in treating occult cases than overt cases: for occult USI preoperatively, it achieved a 97.2 % objective cure and a 94.4 % subjective cure. In overt USI cases, the objective cure rate was 86.5 %, with a subjective cure rate of 84.6 %.
Of the 57/150 patients without Urodynamic Stress Incontinence (USI), the rates of de novo USI (objective) and SUI (subjective) at 12 months were 10.5 % (6/57) and 12.3 % (7/57), respectively ( Fig. 2 ).
Table 2 shows POP-Q measurements pre- and one1 year postoperatively, with significant improvements at POP-Q sites Aa, Ba, C, Ap, and Bp, and significant decrease in total vaginal length. The differences were statistically significant (P < 0.001), reflecting the effectiveness of the surgical interventions.
