A novel metal-free sling approach for benign prostatic hyperplasia: early results of the Progator procedure with high ejaculatory preservation

Introduction

Benign prostatic hyperplasia (BPH) is a prevalent urological condition characterized by the non-malignant enlargement of the prostate gland, primarily affecting older men (1).

Epidemiological studies indicate that BPH affects approximately 50% of men aged 51–60 years and up to 90% of those over 80 years, leading to lower urinary tract symptoms (LUTS) such as urinary frequency, urgency, nocturia, and weak stream (2). These symptoms not only impair daily activities but also significantly diminish quality of life (QoL), contributing to psychological distress, sleep disturbances, and increased healthcare utilization. If left untreated, BPH can progress to complications including acute urinary retention, recurrent urinary tract infections, bladder stones, and renal insufficiency (3).

Current management strategies for symptomatic BPH include watchful waiting, pharmacotherapy (e.g., alpha-adrenergic blockers, 5-alpha reductase inhibitors, or phosphodiesterase-5 inhibitors), and surgical interventions. While medications provide symptomatic relief in mild-to-moderate cases, they are often associated with side effects such as orthostatic hypotension, sexual dysfunction, or the need for lifelong administration (4). For patients with moderate-to-severe LUTS refractory to medical therapy, surgical options like transurethral resection of the prostate (TURP) remain the gold standard, offering durable improvements in International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), and post-void residual (PVR) volume (5).

However, TURP is invasive and carries risks including bleeding (requiring transfusion in 2–5% of cases), urinary incontinence (1–2%), erectile dysfunction, and retrograde ejaculation (occurring in up to 65–75% of patients), which can deter patients concerned about sexual function preservation (6).

To mitigate these drawbacks, minimally invasive therapies (MITs) have gained traction over the past decade. Techniques such as prostatic-urethral lift (UroLift), convective water vapor therapy (Rezum), and aquablation aim to reduce procedural morbidity while maintaining efficacy (7). For instance, UroLift preserves ejaculatory function in over 90% of cases but may be less effective for larger prostates (80 mL), and Rezum offers significant IPSS reductions (approximately 45–50% at 3 months) with low complication rates, though durability beyond 5 years remains under investigation (8,9).

Despite these advances, limitations persist, including variable long-term outcomes, high costs, the need for specialized equipment, and incomplete symptom resolution in some patients, highlighting the demand for innovative approaches that balance efficacy, safety, and preservation of quality-of-life aspects like sexual health.

Progator (endoscopic prostate sling), a novel mechanical device developed by South Korea’s Sorex company, represents a significant advancement in minimally invasive surgical therapy (MIST) for BPH. This technique utilizes a stainless-steel-free polypropylene sling to mechanically compress the lateral prostatic lobes via two strategically placed implants. Its key innovation lies in the intraoperative tension control mechanism: after deploying implants at the verumontanum and 2 cm distal to the bladder neck, surgeons dynamically adjust sling tightness using a dedicated paddle device. This design eliminates urethral metal components (preventing stone formation) while enabling customized urethral expansion with only two implants.

This single-center, retrospective cohort study evaluates the preliminary safety and efficacy of the Progator procedure in men with symptomatic BPH. By assessing changes in LUTS metrics (IPSS, QoL), objective urodynamic parameters (Qmax, PVR volume), prostate-specific antigen (PSA) levels, and adverse events at 4 and 12 weeks post-procedure, we aim to provide foundational evidence for its clinical utility. As an exploratory first-in-human investigation, this study lays the groundwork for larger randomized controlled trials to compare Progator against established therapies and confirm its role in modern BPH management. We present this article in accordance with the STROBE reporting checklist (available at https://tau.amegroups.com/article/view/10.21037/tau-2026-1-0155/rc).

Methods

Study design and ethics

This study was a single-center, retrospective cohort study designed to evaluate the preliminary safety and efficacy of the Progator procedure for patients with symptomatic BPH. Data were collected from patients who underwent the procedure between January 2025 and May 2025 at the Department of Urology, Dong-A University Hospital, Busan, South Korea, with follow-up assessments conducted at 4 and 12 weeks postoperatively. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments (10). The study was approved by the Institutional Review Board (IRB) of Dong-A University Hospital (No. DAUHIRB-25-149), with a waiver of informed consent granted due to the retrospective nature of the analysis and the use of de-identified data.

Patient selection criteria

Patients were identified retrospectively through a comprehensive review of electronic medical records from the databases of the Department of Urology, Dong-A University. Inclusion criteria were applied post hoc and comprised: men aged 45 years or older diagnosed with BPH and moderate-to-severe LUTS, as evidenced by an IPSS total score of 12 or higher; prostate volume ranging from 25 to 80 mL, measured by transrectal ultrasound (TRUS); Qmax of 15 mL/s or less; and documented failure of or refusal to continue medical therapy (e.g., alpha-blockers or 5-alpha reductase inhibitors) (11). Exclusion criteria included a history of prostate cancer, urethral stricture, neurogenic bladder dysfunction, prior prostate surgery or MIT, active urinary tract infection, coagulation disorders, or severe cardiopulmonary comorbidities that contraindicated the procedure (12). From an initial pool of potentially eligible cases, 94 patients with complete records were included for analysis.

Baseline demographics, clinical characteristics, and procedural details were extracted from medical records. These included age, prostate volume, IPSS scores (total, voiding, and storage subscores), Qmax, PVR volume, serum PSA levels, and self-reported ejaculatory function.

To minimize selection bias, study participants were enrolled from an electronic medical record database, and all eligible patients were included without artificial selection or filtering. To reduce information bias, the IPSS score was assessed with the assistance of trained healthcare professionals, and a standardized self-reporting instrument was used for evaluating ejaculatory function.

Intervention: Progator surgical technique

The Progator system (Sorex, Seoul, South Korea) is a novel, metal-free, transurethral mechanical sling designed for the treatment of LUTS secondary to BPH. The device consists of three main components: a polypropylene suspension sling, two types of polyacetal anchors, and a dedicated delivery system.

The sling is a sterile, non-absorbable monofilament polypropylene ribbon (width: 2.5 mm; length: 12 cm), identical to materials used in hernia and stress urinary incontinence surgery, ensuring long‑term biocompatibility and low erosion risk. No metal components (e.g., stainless steel, nitinol) are present, eliminating the risk of urethral stone formation or foreign body migration.

Two anchor types are used: fixed anchors (deployed bilaterally at the verumontanum level) and adjustable anchors (placed approximately 2 cm distal to the bladder neck orifice). Both anchors are made of polyacetal and are self‑expanding; the adjustable anchor incorporates a locking mechanism that permits unidirectional tension adjustment via a paddle slider.

The delivery system comprises a 22-Fr disposable cystoscopic introducer sheath with integrated needle cartridges. All procedures were performed by a single experienced urologist.

Key steps included (Figures 1-4):

• Anesthesia and positioning: surface anesthesia of the urethral mucosa was applied, followed by cystoscopic confirmation of anatomical landmarks, including the verumontanum and bladder neck;
• First anchor implantation: fixed anchors were implanted bilaterally at the verumontanum level to establish a stable suspension base;
• Second anchor implantation: adjustable anchors were placed approximately 2 cm distal to the bladder neck orifice;
• Tension adjustment: the suspension band was tightened using a specialized paddle slider mechanism, with real-time observation of urethral lumen expansion under cystoscopic guidance.

Figure 1 Preoperative condition.

Figure 2 First shooting on the right lobe of the prostate.

Figure 3 Second shooting on the left lobe of the prostate.

Figure 4 Postoperative condition.

No Foley catheter was routinely placed post-procedure, aligning with the technique’s design for minimal invasiveness. Intraoperative monitoring ensured controlled tension to prevent over-correction or tissue damage. Patients were typically discharged on the same day, with follow-up scheduled at 4 and 12 weeks, IPSS scores were collected via questionnaires, and Qmax and PVR volume were measured by uroflowmetry.

Outcome measures

Primary endpoints focused on efficacy at 4 and 12 weeks post-procedure compared to baseline:

• Symptom improvement: changes in IPSS total score and subscores (voiding: questions 1, 3, 5, and 6; storage: questions 2, 4, and 7);
• Urodynamic improvement: changes in Qmax (mL/s).

Secondary endpoints included:

• Sexual function preservation: rate of maintained ejaculatory function (patient self-reported as preserved, retrograde, or absent).

Serum PSA was measured at baseline for safety screening (to exclude occult prostate cancer) and was not a primary or secondary efficacy endpoint. Therefore, post-procedure PSA changes are not reported.

All outcomes were assessed using standardized tools, with IPSS and QoL derived from validated questionnaires, and uroflowmetry performed using calibrated equipment.

Data collection and statistical analysis

Data were sourced from electronic medical records, including preoperative assessments, operative reports, and 4- and 12-week follow-up clinic notes. The sample size was based on consecutive patients, and no formal calculation was performed.

Statistical analysis

Data were analyzed using SPSS software version 27.0 (IBM Corp., Armonk, NY, USA). Descriptive statistics were presented as means ± standard deviations for continuous variables (e.g., age, prostate volume, Qmax) and frequencies/percentages for categorical variables (e.g., ejaculation status). All comparisons between baseline and post-operative (4 and 12 weeks) outcomes were performed using within-group analyses. For continuous variables, paired t-tests were applied when data were normally distributed (assessed by the Shapiro-Wilk test); otherwise, the Wilcoxon signed-rank test was used. For categorical variables (e.g., proportion of patients with preserved ejaculation), McNemar’s test was used to compare pre- and post-procedure proportions. A P value <0.05 was considered statistically significant. Effect sizes for continuous outcomes were calculated using Cohen’s d for paired samples. A P value <0.05 was considered statistically significant. Effect sizes were calculated using Cohen’s d for continuous outcomes to quantify clinical relevance. Missing data were minimal (5%) and handled via listwise deletion.

Results

Patient enrollment and baseline characteristics

This retrospective cohort study included a total of 94 patients with symptomatic BPH who underwent the Progator procedure between January 2025 and May 2025 (Figure 5). Of these, 86 patients had detailed individual records available from the electronic medical records and an Excel spreadsheet, while the remaining 8 were included based on aggregated data due to incomplete individual documentation. All patients completed the 12-week follow-up assessment, with no dropouts or major protocol deviations noted in the records.

Figure 5 Patient enrollment flow diagram. MIST, minimally invasive surgical therapy; UTI, urinary tract infection.

Baseline demographics and clinical characteristics are summarized in Table 1. The mean age was 62 years (range, 45–89 years), and the mean prostate volume, measured by TRUS, was 43.7 mL (range, 26.03–75.43 mL). Patients presented with moderate-to-severe LUTS, as evidenced by a mean total IPSS of 29.0 (voiding subscore: 15.5; storage subscore: 8.5). Objective urodynamic measures included a mean Qmax of 11.8 mL/s (range, 8–13 mL/s) and a mean PVR volume of 89.1 mL. Mean baseline serum PSA was 2.8 ng/mL (range, 0.5–6.2 ng/mL). All patients with PSA >4.0 ng/mL (n=12) had prior negative prostate biopsy within 12 months. All patients reported normal ejaculatory function pre-procedure.

Surgical outcomes

All 94 procedures were successfully completed, achieving a 100% technical success rate with no intraoperative conversions to open surgery or major bleeding.

Efficacy endpoints

Significant improvements were observed in all primary efficacy parameters at 4 weeks post-procedure compared to baseline (Table 2). The mean total IPSS decreased from 29.0 to 15.5 (mean change: −13.5, representing a 46.6% reduction; P<0.001). Subscore analyses revealed reductions in voiding symptoms (15.5 to 8.3, 46.5% reduction; P<0.001) and storage symptoms (8.5 to 7.2, 15.3% reduction; P<0.001). Urodynamic improvements included an increase in mean Qmax from 11.8 to 17.7 mL/s (50.0% improvement; P<0.001). Mean PVR volume decreased from 89.1 mL to 36.2 mL (−59.4%; P<0.001).

Building on these early outcomes, continued improvement was evident at the 12-week follow-up (Table 3). Mean total IPSS fell further to 14.0, representing a 55% reduction from baseline. The voiding subscore decreased to 7.0 (−52%), and the storage subscore to 7.0 (−20%). Mean Qmax rose to 18.5 mL/s, a 57% increase over pre-procedure values. In addition, mean PVR volume dropped from 89.1 to 18.8 mL (−78.9%), underscoring sustained and progressive improvements in both symptom burden and objective flow parameters over the first 3 months.

Functional preservation and safety

Ejaculatory function was preserved in 89.4% (84/94) of patients, based on self-reported assessments. Systematic adverse event data were not collected in this retrospective study. From available clinical notes, no grade ≥ III complications were identified. Specific rates of acute urinary retention, dysuria, hematuria, urinary tract infection, or need for catheterization cannot be reliably reported due to incomplete and non-standardized documentation.

Subgroup findings

Subgroup analyses based on the detailed Excel data (n=86) highlighted the procedure’s efficacy across diverse patient profiles. In patients with prostate volume >50 mL (n=7), Qmax improved from 9.8 to 15.2 mL/s (55.1% increase). Among elderly patients (80 years, n=5), IPSS reductions ranged from 43.2% to 48.1%, consistent with the overall cohort. No significant differences in outcomes were observed between subgroups, suggesting broad applicability.

Discussion

This study represents the first clinical report on the Progator procedure, a novel mechanical MIST utilizing a transurethral suspension technique for symptomatic BPH. Our retrospective analysis of 94 patients demonstrates that Progator achieves substantial short-term improvements in LUTS and urodynamic parameters, with a 55.0% reduction in total IPSS and a 57.0% increase in Qmax at 12 weeks, alongside an 89.4% rate of ejaculatory function preservation and no severe complications. These findings position Progator as a promising advancement in BPH management, particularly for patients seeking therapies that balance efficacy with functional preservation.

Comparison with existing MITs

Progator’s innovative design addresses key limitations of established MISTs, such as UroLift, Rezum, and temporary implantable nitinol devices (TIND), through its dual-anchor dynamic tension adjustment mechanism without permanent urethral metallic components. Unlike UroLift, which relies on nitinol implants and carries a 3–5% risk of urethral stone formation due to chronic foreign body presence, Progator eliminates metallic residues, resulting in no stone-related events in our cohort. This non-implant approach may also reduce long-term complications like migration or encrustation, potentially improving patient tolerance.

Furthermore, the single-device system enables efficient urethral expansion via a paddle slider for real-time tension control, minimizing the number of anchors needed—especially for larger prostates (50 mL)—and shortening the learning curve compared to UroLift’s multi-implant technique. All procedures in this study were completed under local anesthesia in a short time, supporting outpatient feasibility and rapid recovery, in contrast to Rezum or TIND, which often require regional anesthesia and longer operative times. The absence of post-procedure catheterization further enhances patient comfort and reduces infection risks, aligning with trends toward less invasive BPH interventions.

Efficacy and functional outcomes

The observed improvements in IPSS (55.0% reduction) and Qmax (57.0% increase) are comparable to or exceed short-term outcomes from UroLift (IPSS reduction of 49.9% at 3 months) and Rezum (IPSS reduction of 51.4% at 3 months) (7) (Table 4). Notably, Progator’s ejaculatory preservation rate of 89.4% surpasses that of ablative procedures like TURP or holmium laser enucleation of the prostate (HoLEP), where rates are below 30% due to ejaculatory duct disruption (13), and even outperforms Rezum’s preservation. This advantage likely stems from the procedure’s anatomical focus on verumontanum-level anchoring, which spares ejaculatory structures while mechanically widening the prostatic urethra, consistent with emerging paradigms prioritizing sexual function in BPH treatment.

Clinical implications

Progator’s profile offers practical advantages for clinical practice, including optimized patient selection for those with moderate prostate sizes and a preference for sexual function preservation. The low complication rate and rapid recovery could reduce healthcare burdens, particularly in ambulatory settings.

Limitations

Several limitations warrant consideration. The single-arm, retrospective design precludes direct comparisons with controls, potentially introducing selection bias and confounding factors like placebo effects or natural symptom fluctuations. Although appropriate paired statistical methods were applied for pre-post comparisons, the lack of a control group limits causal inference and may introduce bias from temporal trends or regression to the mean. Follow-up was limited to 12 weeks, restricting insights into long-term durability. Statistical analyses, while demonstrating significance, lacked multivariable adjustments (e.g., for age or prostate volume) due to reliance on Excel data, and the cohort’s single-center nature may limit generalizability. Additionally, self-reported ejaculatory function introduces subjectivity, and objective metrics (e.g., semen volume analysis) were not available.

A major methodological limitation is the use of a non-validated, simplified self-report tool for ejaculatory function, rather than the recommended Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD) (14) or comparable validated instruments. This approach is prone to recall bias, lacks granularity, and may fail to detect clinically meaningful changes in ejaculatory function such as reduced semen volume or diminished orgasmic pleasure. Accordingly, the reported 89.4% ejaculatory function preservation rate should be interpreted as an exploratory estimate rather than a definitive outcome. Future prospective investigations should employ validated sexual function questionnaires to precisely evaluate ejaculatory outcomes after the Progator procedure.

Moreover, this is an exploratory, retrospective study without a priori sample size calculation or power analysis. Therefore, the findings should be considered hypothesis-generating rather than confirmatory. Future prospective randomized trials with pre-specified sample size calculations are required to definitively establish the efficacy and safety of the Progator procedure.

Beyond these points, another important limitation relates to safety monitoring. Systematic, prospective adverse event collection was not performed in this study. Mild events such as transient dysuria, hematuria, acute urinary retention, or catheterization may have been underreported or incompletely documented. Therefore, the safety profile of the Progator procedure cannot be fully assessed from this dataset. Future prospective studies should employ standardized adverse event reporting instruments (e.g., Clavien-Dindo classification, patient diaries) (15) and predefined event definitions.

Nevertheless, Progator emerges as the first metal-free mechanical MIST, offering efficacious symptom relief, superior ejaculatory preservation, and procedural simplicity through dynamic tension adjustment. These attributes represent a paradigm shift in BPH therapy, but validation through prospective, multicenter randomized controlled trials with longer follow-up and comprehensive cost-effectiveness analyses is essential to confirm its role in clinical guidelines.

Conclusions

This study shows that the Progator procedure is a safe and effective mechanical minimally invasive option for the treatment of symptomatic BPH. It significantly improves LUTS and urinary flow while preserving ejaculatory function in most patients, with no severe complications observed. However, to accurately define the safety profile of the Progator procedure, prospective studies with rigorous adverse event monitoring—including predefined event definitions and systematic collection of LUTS and catheterization needs—are warranted. Further large-scale, prospective investigations are also needed to confirm its long-term efficacy and cost-effectiveness.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://tau.amegroups.com/article/view/10.21037/tau-2026-1-0155/rc

Data Sharing Statement: Available at https://tau.amegroups.com/article/view/10.21037/tau-2026-1-0155/dss

Peer Review File: Available at https://tau.amegroups.com/article/view/10.21037/tau-2026-1-0155/prf

Funding: This research was funded by the Bio & Medical Technology Development Program of the National Research Foundation (NRF), funded by the Korean government (MSIT) (No. RS-2023-00236157).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-2026-1-0155/coif). All authors report that this research was funded by the Bio & Medical Technology Development Program of the National Research Foundation (NRF), funded by the Korean government (MSIT) (No. RS-2023-00236157). The authors have no other conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Institutional Review Board (IRB) of Dong-A University Hospital (No. DAUHIRB-25-149), with a waiver of informed consent granted due to the retrospective nature of the analysis and the use of de-identified data.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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