The EnPlace^® Device for Advanced Apical Prolapse: Anatomical Outcomes and Long-Term Satisfaction

Abstract

Background: Apical pelvic organ prolapse remains a considerable surgical challenge given its comparatively high recurrence rates. The EnPlace^® device provides a mesh-free, minimally invasive option for sacrospinous ligament fixation (SSLF). This study evaluates the long-term safety and durability of SSLF performed with the EnPlace^® device. Methods: We conducted a retrospective cohort study at Assuta Medical Center between October 2020 and October 2021, enrolling 91 patients with stage III–IV apical POP who underwent SSLF with the EnPlace^® device. Data were extracted from a real-time institutional database. Patients were assessed at 1 day, 1 month, and 6 months postoperatively, and patient-reported satisfaction was subsequently obtained by telephone interview at 3–4 years. Results: The cohort comprised 91 women (mean age 63.9 ± 11.85 years); prolapse was uterine in 80 (87.9%) and involved the vaginal vault in 11 (12.1%), with mean preoperative point C measurements of 2.11 ± 3.04 and 1.55 ± 3.01, respectively. Concomitant colporrhaphy was performed in all patients, and 19 (20.9%) also underwent a mid-urethral sling. Surgery lasted a mean of 23.46 ± 5.09 min, with mean blood loss of 23.7 ± 6.06 mL, and no intraoperative or early postoperative complications were recorded. By 6 months, POP-Q values had improved to a mean point C of −4.84 ± 1.05 cm, point Ba of −2.25 ± 0.69 cm, and point Bp of −2.63 ± 0.69 cm. Surgical failure occurred in two patients (2.5%) with uterine prolapse, both of whom were successfully managed with repeat SSLF using EnPlace^®, and recurrent stage II cystocele was identified in five patients (5.2%), all treated with a pessary. At 3–4 years, patient-reported satisfaction was available for 75 of 91 patients (82.4%) and averaged 91.93% ± 17.06; no repeat objective (POP-Q) assessment was performed at this later time point. Conclusions: These findings indicate that the EnPlace^® device offers a favorable safety and efficacy profile for apical POP repair, characterized by low recurrence and high patient satisfaction, representing a promising alternative to conventional techniques. Given its minimally invasive nature and compatibility with regional anesthesia, this approach may be of particular interest for older or higher-risk surgical candidates; further prospective research incorporating formal frailty and surgical-risk assessment is warranted to confirm this potential benefit.

1. Introduction

Pelvic organ prolapse (POP) is a prevalent condition impacting up to 19% of women worldwide, often necessitating surgical intervention to alleviate symptoms and improve quality of life [1]. POP can affect the anterior, apical, or posterior compartments of the pelvic floor. Apical prolapse, which involves the descent of the uterus or vaginal vault, presents a significant challenge in surgical management due to the need for deep pelvic dissection and its association with high rates of recurrence [2,3,4]. Despite various surgical options available, ranging from uterine-sparing procedures to hysterectomy, no single apical suspension technique has demonstrated clear superiority in terms of durability [5,6,7]. These procedures can be performed via abdominal or vaginal approaches, each with its own advantages and limitations [3].

In recent years, there has been a trend towards the abdominal approach using minimally invasive techniques such as robotics or laparoscopy [8]. These methods offer enhanced visualization and precision but come with certain drawbacks, including longer operation times, the requirement of advanced surgical skills, higher costs, the need for mesh implants, and the necessity for general anesthesia [9]. Conversely, many surgeons continue to advocate for vaginal techniques due to their shorter operation time, enhanced safety profile, avoidance of mesh, and cost-effectiveness compared to abdominal approaches [10]. Moreover, vaginal surgeries can be performed under spinal anesthesia, making them particularly suitable for older, more fragile women who are more likely to suffer from apical prolapse [11].

Among vaginal techniques, sacrospinous ligament fixation (SSLF) is often favored over high uterosacral ligament fixation (HUSLF) due to its reduced risk of ureteral injury [7]. However, traditional SSLF requires extensive dissection into the pelvis depth, which can be surgically challenging and carries a risk of local hematoma formation [10].

EnPlace^® is a novel, truly minimally invasive, meshless device designed for transvaginal sacrospinous ligament fixation of apical POP [12]. This device aims to simplify the procedure by eliminating the need for deep pelvic dissection and the use of mesh, which has been linked to complications such as mesh erosion and chronic pain. Previous studies have evaluated the safety and short-term efficacy of EnPlace^®, demonstrating promising results in small cohorts [12,13,14]. Mechanistically, the EnPlace^® device (formerly known as NeuGuide™) consists of an anchor unit and a purpose-built delivery system: the anchor, which carries an attached surgical suture, is inserted transvaginally and deployed directly into the sacrospinous ligament, allowing the surgeon to secure apical support without the deep pelvic dissection or mesh placement required by conventional SSLF.

This study aims to assess the safety and durability of the EnPlace^® device up to four years post-surgery. By expanding the sample size and extending the follow-up period, it seeks to provide robust data on the long-term outcomes of this technique, potentially offering a safer and more effective alternative to traditional methods, e.g., [1,2,3,4,5,6].

2. Materials and Methods

A Retrospective cohort study was conducted at Assuta Medical Center from October 2020 to October 2021. The medical records of all patients who underwent SSLF using the EnPlace^® device (FEMSelect, Modi’in, Israel) for stage III–IV apical POP were reviewed. Patients with a full follow-up to 6 months postoperatively were included, while those with missing data were excluded.

The computerized database is updated in real-time by the surgeon and was subsequently reviewed by the co-authors. Demographic, clinical, intraoperative, and postoperative data were collected and analyzed from a computerized database.

The severity of POP was evaluated by a certified urogynecologist (MN) using the POP-Quantification (POP-Q) system. POP-Q measurements involve six specific vaginal locations and three anatomical landmarks, measured in centimeters relative to the hymen during a maximal Valsalva maneuver. Apical prolapse is represented by point C, indicating the lowest part of the uterine cervix or vaginal vault, and the severity of prolapse is classified into stages I–IV, with stages III–IV considered significant POP. The diagnosis of stress urinary incontinence (SUI) was established through questionnaires and physical examinations demonstrating leakage associated with urethral hypermobility. All operations were performed under general anesthesia by a single board-certified urogynecologist (MN). Concomitant procedures, such as colporrhaphies or tension-free vaginal tape (TVT) placements, were performed as necessary.

All 91 patients underwent SSL fixation for significant apical POP using the EnPlace^® device. The patients were divided into two sub-groups: 80 (87.9%) with uterine prolapse and 11 (12.1%) with vault prolapse. Comparisons were made between these two sub-groups. The EnPlace^® device (formerly known as NeuGuide™) is an innovative tool designed to provide apical support for the uterine cervix and/or the vaginal vault apex without requiring deep pelvic vaginal dissection or mesh implants. The device includes an anchor unit and a delivery system, enabling precise insertion and deployment of the anchor through the vaginal wall via SSL. The anchor, equipped with a surgical suture, ensures secure fixation and facilitates the repair process. Exclusion criteria for SSL fixation with the EnPlace^® device included reproductive tract anomalies, prior pelvic radiation therapy, pelvic malignancy, pelvic inflammatory disease, or a known allergy to nickel or nitinol. The EnPlace^® device is FDA-approved, and its surgical technique and instrumentation have been thoroughly tested and described in previous studies [12,13].

Follow-up assessments were conducted at 1 day, during which patients were asked to rate their pain using a visual analog scale (VAS) score from 1 to 10. Additionally, all patients were reviewed at 1 and 6 months postoperatively. The postoperative evaluation included anatomical and functional rates, pain, dyspareunia, and other complications. Surgical success was defined as the absence of POP symptoms, no observed apical POP beyond stage I, and no need for recurrent apical POP surgery or a vaginal pessary during the follow-up period. Patient long-term satisfaction was determined by asking each patient to estimate their overall satisfaction with the surgical repair in terms of symptom improvement (0–100%). Patients were contacted via phone call prior to this study’s publication (June 2024) and were asked again to rate their satisfaction. No repeat anatomical (POP-Q) examination was performed at this final telephone contact, and information on interval prolapse recurrence, reoperation, or new pessary use between the 6-month visit and this contact was not systematically collected.

Statistical analysis was performed using Student’s t-test for continuous data and Fisher’s exact test for categorical data. Data are presented as mean ± standard deviation (SD) or percentages, as appropriate. All statistical tests were two-sided, and a p-value of less than 0.05 was considered statistically significant. Statistical analysis was conducted using SPSS software, version 28 (IBM Corporation, Armonk, NY, USA).

The study was approved by the Institutional Ethics Committee of Assuta Medical Center and adhered to the Declaration of Helsinki (protocol code 0023-24-ASMC; date of approval: 15 July 2024). Given its retrospective and anonymized nature, informed consent was waived.

3. Results

3.1. Patient Characteristics and Baseline Data

A cohort of 91 patients (mean age 63.9 ± 11.85 years; range 57–72 years) with significant stage III–IV apical POP met the study criteria and was included in the analysis. Prior to the current surgery, 80 patients (87.9%) presented with stage III or IV uterine prolapse, and 11 patients (12.1%) had stage III or IV vaginal vault prolapse. All patients underwent apical sacrospinous ligament fixation using the EnPlace^® device.

The demographic and clinical characteristics of these patients were consistent across the group and are presented in Table 1. Specifically, background conditions such as diabetes, hypertension, and cardiac and lung disease were comparable between the groups. Prolapse stage, as evaluated by POP-Q at points C, Ba, and Bp, had similar scores between the groups, with average positions of at +2.04 ± 3.02, +2.79 ± 1.80, and +0.95 ± 1.47, respectively. Notably, rates of SUI were comparable between the groups and estimated at 25.3% in the entire cohort.

Table 1. Patient Demographics and Preoperative Characteristics.

Characteristic	Total No. of Patients, N = 91	Uterine Prolapse, N = 80	Vault Prolapse, N = 11	p Value
Age (Mean ± SD)	63.9 ± 11.85	64.3 ± 12.2	60.6 ± 9.0	0.33
Parity (Median, IQR)	3 (2–4)	3 (2–4)	4 (3–5)	0.24
Diabetes mellitus, N (%)	7 (7.2%)	6 (7.5%)	1 (9.1%)	0.85
Hypertension, N (%)	21 (21.6%)	18 (22.5%)	3 (27.3%)	0.72
Cardiac disease, N (%)	3 (3.3%)	3 (3.8%)	0 (0.0%)	0.51
Prolapse duration, years (Median, IQR)	1 (1–4)	2 (1–3)	2 (1–5)	0.81
Point C, cm a (Mean ± SD)	+2.04 ± 3.02	2.11 ± 3.04	1.55 ± 3.01	0.56
Point Ba, cm a (Mean ± SD)	+2.79 ± 1.80	2.79 ± 1.74	2.82 ± 2.23	0.96
Point Bp, cm a (Mean ± SD)	+0.95 ± 1.47	0.86 ± 1.41	1.55 ± 1.75	0.15
Dyspareunia, N (%)	1 (1.1%)	0 (0.0%)	1 (9.1%)	0.91
SUI, N (%)	23 (25.3%)	18 (22.5%)	5 (45.5%)	0.15
Obstructive defecation, N (%)	3 (3.3%)	3 (3.8%)	0 (0.0%)	0.51

SD—Standard deviation, IQR—interquartile range, SUI—stress urinary incontinence. ^a Taken from POP-Quantification measurement.

3.2. Intraoperative Characteristics and Outcomes

The average surgery duration was 23.46 ± 5.09 min (range 20–25 min), and the mean blood loss was 23.7 ± 6.06 mL (range 20–25 mL). There were no complications during surgery or in the early postoperative period, and all patients were discharged either the same day or the following day. Pain on postoperative day one was assessed using the VAS score and was low and comparable across groups, with a median of 2.2. Immediately after the repair, the POP-Q measurements were assessed again by the surgeon and showed the average position of point C at −5.66 ± 0.52 cm, point Ba at −2.96 ± 0.47 cm, and point Bp at −2.89 ± 0.31 cm. The distribution of the points between the groups was similar. All 91 patients (100%) had concomitant colporrhaphies for cystocele and rectocele repair, with 19 patients (20.9%) also receiving a mid-urethral sling. The intraoperative characteristics and outcomes are displayed in Table 2.

Table 2. Intraoperative Parameters and Surgical Details.

Characteristic	Total No. of Patients, N = 91	Uterine Prolapse, N = 80	Vault Prolapse, N = 11	p Value
Concomitant colporrhaphy, N (%)	91 (100.0%)	80 (100.0%)	11 (100.0%)	NA
Concomitant MUS, N (%)	19 (20.9%)	16 (20.0%)	3 (27.3%)	0.58
Blood loss, ml (Mean ± SD)	23.7 ± 6.06	23.44 ± 6.10	25.00 ± 5.91	0.43
Duration of surgery, min (Mean ± SD)	23.46 ± 5.09	23.38 ± 5.02	24.09 ± 5.89	0.66
Post-repair Point C, cm a (Mean ± SD)	−5.66 ± 0.52	−5.66 ± 0.53	−5.64 ± 0.50	0.88
Post-repair Point Ba, cm a (Mean ± SD)	−2.96 ± 0.47	−2.94 ± 0.49	−3.10 ± 0.30	0.31
Post repair Point Bp, cm a (Mean ± SD)	−2.89 ± 0.31	−2.89 ± 0.32	−2.91 ± 0.30	0.83
Hospitalization duration, Days (Mean ± SD)	1.02 ± 0.14	1.03 ± 0.16	1.00 ± 0.00	0.61
Pain in POD1, VAS (Median, IQR)	2.2 (1.2–2.3)	2.2 (1.2–2.3)	2.3 (1.2–3.3)	0.186

SD- Standard deviation, MUS- mid urethral sling, POD- postoperative day 1. ^a Taken from POP-Quantification measurement.

3.3. Postoperative Outcomes

3.3.1. Short-Term Postoperative Outcomes (Up to 6 Months)

At the 1-month follow-up, in-person assessment showed favorable anatomical outcomes in both groups, with a mean patient satisfaction of 95.2%. At the 6-month follow-up, each of the points measured was slightly less optimal than the measurements taken at one month. Paired t-tests examining the change in mean scores of points C, Ba, and Bp between the two periods (1 month vs. 6 months) were statistically significant (p < 0.01 for all). Nonetheless, at 6 months, anatomical results were favorable, with the average position of point C at −4.84 ± 1.05 cm, point Ba at −2.25 ± 0.69 cm, and point Bp at −2.63 ± 0.69 cm. Out of the 80 patients with preoperative uterine prolapse, 2 patients (2.5%) experienced a failure of the surgery within 6 months; both presented with apical prolapse recurrence (point C = 2). One patient underwent reoperation at 10 months and the other at 2 years after the index surgery, each receiving a repeat SSLF procedure using the EnPlace^® device, with good outcomes. At 2 years after the repeat surgery, both patients were satisfied and reported no prolapse symptoms. There was a single case of recurrence that was asymptomatic and did not require further intervention. Among the 11 patients with preoperative vault prolapse, none had a recurrence or failure. Overall, postoperative assessments showed no new significant lower urinary tract symptoms, bowel symptoms, or dyspareunia. Additionally, of all 91 patients, 5 patients (5.2%) developed recurrent stage II cystocele, all of whom were successfully managed with a pessary. A single patient (1.1%) had a single episode of urinary tract infection, with no recurrences reported.

3.3.2. Long-Term Postoperative Outcomes

Patient satisfaction, assessed at the final telephone follow-up conducted 3–4 years after surgery, was available for 75 of the 91 patients (82.4%); the remaining 16 patients (17.6%) could not be reached or did not respond and were not included in this analysis. Among the 75 patients with available data, the mean satisfaction score was 91.93 ± 17.06 out of 100, indicating significant symptom improvement. No systematic differences in baseline characteristics were identified between patients with and without long-term follow-up data; the potential impact of attrition/non-response bias on this estimate is addressed in the Discussion.

Table 3 shows the postoperative outcomes and long-term patient satisfaction.

Table 3. Postoperative Outcomes and Long-term Patient Satisfaction.

Characteristic	Total No. of Patients, N = 91	Uterine Prolapse, N = 80	Vault Prolapse, N = 11	p Value
1 month follow up
Point C, cm a, (Mean ± SD)	−5.41 ± 0.63	−5.42 ± 0.65	−5.27 ± 0.46	0.45
Point Ba, cm a, (Mean ± SD)	−2.65 ± 0.50	−2.64 ± 0.50	−2.73 ± 0.46	0.58
Point Bp, cm a, (Mean ± SD)	−2.82 ± 0.38	−2.83 ± 0.38	−2.82 ± 0.40	0.94
Satisfaction (0–100%), (Mean ± SD)	95.21 ± 6.75	95.06 ± 6.95	96.36 ± 5.04	0.55
6 months follow up
Point C, cm a, (Mean ± SD)	−4.84 ± 1.05	−4.81 ± 1.11	−5.00 ± 0.00	0.58
Point Ba, cm a, (Mean ± SD)	−2.25 ± 0.69	−2.28 ± 0.73	−2.09 ± 0.30	0.41
Point Bp, cm a, (Mean ± SD)	−2.63 ± 0.69	−2.61 ± 0.72	−2.73 ± 0.46	0.61
Satisfaction (0–100%), (Mean ± SD)	92.80 ± 9.28	92.42 ± 9.64	95.45 ± 5.68	0.31
Failure (N%)	2 (2.2%)	2 (2.5%)	0 (0.0%)	0.59
Recurrence N (%)	1 (1.1%)	1 (1.3%)	0 (0.0%)	0.71
3–4 years telephone follow-up, N = 75
Satisfaction (0–100%), (Mean ± SD)	91.93 ± 17.06	91.21 ± 17.84	97.22 ± 8.33	0.32

SD—Standard deviation, IOR—interquartile range, SUI—stress urinary incontinence. ^a Taken from POP-Quantification measurement.

4. Discussion

In this retrospective cohort study, we aimed to evaluate the short-term and long-term efficacy and safety profile of the EnPlace^® device for treating stage III–IV apical POP. Our data revealed a relatively short, minimally invasive procedure, associated with minimal blood loss. No mesh implants were used. No complications were observed during surgery or in the early postoperative period. The recurrence rate was 2.5%, and overall long-term (3–4-year) patient-reported satisfaction, available for 82.4% of patients, was 91.93%. No significant differences were observed between vaginal vault repair and uterine prolapse repair.

Purposefully aimed to elevate patients’ quality of life, pelvic floor prolapse repair procedures demand ongoing refinement and innovation in treatment modalities to ensure the safest and most comfortable procedures for patients, optimizing outcomes while mitigating procedural risks.

The safety and efficacy of the EnPlace^® device have been previously investigated in several studies, and our findings are consistent with these earlier reports. Gold et al. [14] described a recurrence rate of 8.8% six months post-surgery in 123 patients, with a median improvement score of 87.3. Weintraub et al. [12] observed high satisfaction levels (8–9 on a scale of 0–10) in ten patients with no recurrences at six months. Ben Zvi et al. [13] reported a 92.3% surgical success rate in 13 patients, with a single recurrence at four years and a median satisfaction score of 88.75. All these studies, consistent with our findings, reported no significant injuries to the bladder, rectum, or major vessels. Notably, despite slightly less optimal anatomical outcomes at six months, as reflected by lower POP-Q scores, the results remained favorable. Comparatively, POP-Q scores from other methods show similar trends over time, indicating that the EnPlace^® device’s long-term effectiveness is competitive with established techniques [15].

Addressing apical prolapse repair can be challenging due to varying outcomes associated with different surgical approaches. While many studies favor the transabdominal approach, including sacrocolpopexy or sacrohysteropexy, for its superior efficacy in providing durable support to the pelvic organs, the literature is not unequivocal [7,16,17]. Failure rates quoted as higher using the vaginal approach are primarily based on objective measures; however, there appear to be similar rates of subjective failure, reoperation for pelvic organ prolapse recurrence, and complications after vaginal suture suspensions when compared with abdominal sacrocolpopexy. Additionally, this approach entails extended recovery periods, prolonged operative times, increased financial burden, and requires proficiency in laparoscopic or robotic techniques [9]. Furthermore, due to the necessity of general anesthesia, this procedure may not be suitable for all patients. Lastly, the use of mesh for suspending the apex to the sacral ligament exposes patients to mesh-related complications, such as mesh erosion and chronic pain [18,19,20].

Alternatively, a transvaginal surgical approach can be utilized to repair apical POP. Common available transvaginal procedures utilizing native vaginal tissue are USLS and SSLF. However, these procedures are not without risks [5]. The USLS carries a higher risk of urethral occlusion, estimated to be 1–9% [21]. SSLF, on the other hand, requires extensive dissection to expose pelvic structures, increasing the risk of hematoma, pelvic organ injury, neurologic pain, and dyspareunia [7].

Given that no single vaginal method has proven superior in terms of anatomic, functional, and adverse event outcomes for apical suspension, it is crucial to prioritize the safest, least invasive approach. The EnPlace^® device offers the benefits of a minimally invasive vaginal approach without the use of mesh. The precise insertion of the anchor into the sacrospinous ligament eliminates the need for deep dissection, which may contribute to a favorable safety profile; however, given the retrospective design of this study and the absence of a direct comparator, this potential advantage requires confirmation in comparative studies. It also enables uterine preservation for women who have a personal or medical preference for this option while maintaining good surgical outcomes. Additionally, its learning curve is considered by some to be shorter than that of conventional SSLF, which could facilitate broader adoption across healthcare settings, although this has not been formally quantified. This approach is particularly suitable for patients who may not tolerate more invasive procedures well, pending confirmation in comparative studies. Despite the initial cost of the device, its overall cost-effectiveness is achieved through shorter surgery durations, reduced hospitalization, and fewer complications, leading to significant savings for healthcare systems in the long run.

Several procedural characteristics of the EnPlace^® device provide a plausible rationale for its particular suitability in older or frailer patients, even though this study did not formally assess frailty or surgical risk. The ability to perform the procedure under regional rather than general anesthesia may reduce perioperative cardiopulmonary risk in this population [11]. Additionally, the short operative time, minimal blood loss, avoidance of deep pelvic dissection, and short hospitalization observed in this cohort may translate into lower rates of anesthesia-related complications, transfusion need, and hospitalization-associated morbidity (e.g., delirium, deconditioning) that disproportionately affect frail and elderly surgical candidates. Prospective studies incorporating formal frailty indices are needed to substantiate this hypothesis.

Despite these advantages, the adoption of new techniques in medicine often faces resistance due to established practices, training requirements, and skepticism about new technologies. Overcoming these barriers is essential for adopting safer and more effective treatments like the EnPlace^® device. Encouraging training programs and sharing outcomes can help integrate innovative techniques into standard practice. It should be emphasized that the existing literature on EnPlace^® and comparable meshless anchoring systems remains limited in volume and heterogeneous in design, patient population, and outcome measures, which constrains the ability to draw firm comparative conclusions. Our findings should therefore be interpreted as complementary to, rather than definitive within, this still-evolving evidence base, and any apparent discrepancies with other reports on SSLF and related apical suspension techniques most plausibly reflect differences in patient selection, surgical experience, follow-up duration, and the outcome measures used, rather than a true difference in the safety or efficacy of the underlying approach. This is illustrated by a recent direct comparative study of EnPlace^® versus the Seratom MN2^® mini-mesh system for apical suspension, which found high long-term anatomical success with both systems, significantly higher long-term patient satisfaction with EnPlace^®, and shorter operative time, blood loss, and hospitalization with EnPlace^®, alongside low complication rates for both devices [22]. Future research should therefore prioritize prospective comparative studies against conventional SSLF and other established techniques, with standardized long-term objective (POP-Q) follow-up and validated patient-reported outcome measures rather than telephone-based satisfaction alone; multicenter designs with independent outcome assessment; and systematic tracking of device-specific complications, the learning curve, cost-effectiveness, and long-term durability through dedicated registries.

This study’s strength lies in the inclusion of both short- and long-term follow-up periods with robust data and strict postoperative follow-up. The fact that all procedures were performed by the same surgeon eliminates variability in surgical technique and reduces potential bias. Additionally, the use of a real-time updated database ensures accurate and timely data collection. Comprehensive patient satisfaction evaluations, including follow-up years after surgery, provide a thorough understanding of long-term outcomes. Moreover, the study’s inclusion of a diverse patient population with varying stages of apical prolapse enhances the generalizability of the findings.

However, this study has several limitations. The small sample size may limit the generalizability of the results. The study included retrospective data assessment without a control group representing alternative surgical modalities beyond the two cohorts studied, so it cannot determine how the intervention compares to other established surgical techniques. Randomized trials or matched comparative cohorts including diverse surgical approaches with standardized long-term objective follow-up are needed. Furthermore, all surgeries and POP-Q assessments were performed by the same surgeon (M.N.), who is also the Founder of the EnPlace^® device; the study database, however, was independently reviewed for accuracy by two co-authors without a financial relationship to the manufacturer. Nonetheless, because M.N. performed both the surgeries and the anatomical (POP-Q) assessments, an assessor-related bias in outcome ascertainment cannot be entirely excluded. Moreover, objective anatomical (POP-Q) assessment was performed only up to 6 months postoperatively; the 3–4-year outcome reflects patient-reported satisfaction obtained by telephone interview only, without a repeat examination. This reliance on a non-validated, subjective, patient-reported measure reduces measurement reliability, increases susceptibility to recall and reporting bias, and limits comparability with other studies using standardized instruments. Long-term satisfaction data were available for 75 of the 91 patients (82.4%); the 16 patients (17.6%) who could not be reached may differ systematically from those who responded, and the possibility of attrition/non-response bias affecting the reported long-term satisfaction rate cannot be excluded. In addition, because all patients underwent concomitant anterior and/or posterior colporrhaphy, and 19 patients (20.9%) also underwent a concomitant mid-urethral sling, the independent contribution of the EnPlace^® device to the reported anatomical and functional outcomes cannot be determined from this study design. Additionally, a comprehensive cost analysis was not performed. Regarding the EnPlace^® device itself, several practical considerations should be weighed alongside the favorable outcomes reported here: two patients (2.5%) in this cohort experienced surgical failure requiring reoperation with the same device; it carries an added material cost compared with suture-only conventional SSLF; and although its learning curve is considered shorter than that of conventional SSLF, this has not been formally quantified in this or prior studies of the device.

5. Conclusions

The EnPlace^® device for SSLF is associated with favorable anatomical outcomes, low recurrence rates, and high patient satisfaction up to four years postoperatively in the surgical management of apical pelvic organ prolapse. Given its minimally invasive, mesh-free technique, this procedure may represent a reasonable option for appropriately selected patients seeking a safe, minimally invasive alternative to traditional surgical methods. However, this study did not include a direct comparison with established SSLF or other apical suspension techniques; prospective comparative studies are needed before firm conclusions can be drawn regarding the relative advantage of the EnPlace^® device over existing approaches.