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Background:
Communication

Mapping the Shifting Landscape of Urological Innovation

by
Samuel Sii
1,2,*,
David Homewood
3,4,5,*,
Brendan Dittmer
2,
Kalonji Nzembela
2,
Mahesha Weerakoon
2,
Jonathan S. O’Brien
5,
Damien Bolton
1,3,
Nathan Lawrentschuk
3,4,6,7,
Niall M. Corcoran
3,4,6 and
Dinesh K. Agarwal
3,4,5
1
Department of Urology, Austin Health, Melbourne 3084, Australia
2
Department of Urology, Sunshine Coast University Hospital, Queensland 4575, Australia
3
Department of Surgery, University of Melbourne, Melbourne 3010, Australia
4
Department of Urology, Western Health, Melbourne 3011, Australia
5
Department of Urology, The Royal Melbourne Hospital, Melbourne 3052, Australia
6
Division of Surgery, Victorian Comprehensive Cancer Centre, Melbourne 3052, Australia
7
EJ Whitten Prostate Cancer Research Centre, Melbourne 3002, Australia
*
Authors to whom correspondence should be addressed.
Soc. Int. Urol. J. 2025, 6(1), 22; https://doi.org/10.3390/siuj6010022
Submission received: 18 October 2024 / Revised: 8 January 2025 / Accepted: 20 January 2025 / Published: 19 February 2025
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Abstract

:
Introduction: Surgical innovation in urology has significantly transformed clinical practice, balancing the need for dissemination of novel techniques with rigorous safety and efficacy standards. Surgical innovation is influenced by regulatory standards, cost-effectiveness, and evolving publication requirements. This study examines publication trends in pioneering urological procedures and their implications on surgical innovation. Methods: This study analyzed 68 pioneering urological publications, examining the relationship between case numbers and publication trends over time. Data were collected through comprehensive database searches and analyzed using linear regression to identify correlations between publication case numbers and innovation dissemination. Results: A significant increase in the number of cases per publication was observed over time (R2 = 0.798, OR = 6.29, 95% CI: 2.57–10.02, p = 0.007). Early transformative techniques were frequently published as single-case reports or small series, whereas incremental innovations required larger case volumes, potentially delaying publication from resource-limited settings. Conclusions: This study highlights the need for a merit-based approach to evaluating surgical innovations, balancing rigorous safety standards with timely dissemination. Frameworks like IDEAL offer structured pathways for evaluating surgical innovations, ensuring robust evidence generation while maintaining flexibility for diverse practice settings. This study advocates for a reassessment of publication criteria to foster a balance between innovation, safety, and inclusivity, ultimately promoting the efficient and equitable advancement of surgical techniques.

1. Introduction

Innovation is key to the advancement of medicine and subsequent improvement in patient care [1]. This is particularly true in surgery, where pioneering techniques have transformed operative management from historically highly risky, peri-morbid, and disfiguring procedures to contemporary low-risk and minimally invasive approaches [2]. There is a delicate balance between enabling innovation and minimizing patient harm [3]. However, the pathway to surgical innovation is often fraught with numerous barriers, including the need to demonstrate not only clinical effectiveness but also cost-effectiveness and safety. Regulatory requirements from agencies such as the Food and Drug Administration (FDA), European Medicines Agency (EMA), and National Institute for Health and Care Excellence (NICE) further complicate this landscape, each imposing distinct standards and hurdles that must be navigated before new techniques can be widely adopted [4].
A critical factor contributing to the propensity of journals to accept publications on novel surgical techniques is the number of cases included in the study. Higher case numbers often provide stronger evidence for the efficacy and safety of a procedure, making it more likely to gain acceptance from both peer-reviewed journals and regulatory bodies [5,6]. This emphasis on case numbers reflects a broader shift towards evidence-based practice, where substantial case series are needed to justify the adoption of new procedures, especially those that may involve higher costs or increased surgical risks.

2. Objectives

Our research aims to explore how publication trends, specifically regarding case numbers, have evolved over time within the urological domain. By examining pioneering urological publications, we aim to understand whether there has been a shift in the number of cases required for a technique to be considered innovative and worthy of publication. This analysis focuses on providing valuable insights into the changing landscape of surgical innovation and the factors influencing the dissemination of novel techniques in urology. Our findings seek to contribute to a more nuanced understanding of how surgical innovation can be fostered while ensuring patient safety and efficacy remain paramount.

3. Methods

To explore this, a list of key urological operations was generated by a consultant urologist (D.A.), collated and cross referenced to urology operative texts (S.S. and D.H.). These novel techniques in urology were then assessed using a structured multi-reviewer analysis of pioneering urological publications. Criteria for inclusion were the first publication by chronological order describing a novel urological procedure on human subjects. This included initial multi search engine using Scopus, Ovid Medline, and PubMed. English language search was performed, and all published languages were included via reference chasing. Literature search and reference tracing were independently performed by multiple reviewers (S.S., B.D., and T.N.) with centralized adjudication and review (D.H.). Data extracted included paper title and type, year and journal of publication, number of cases with which technique was published, and technical procedural description. Data were analyzed to assess trends in case volume per publication over time with linear regression, and results were presented as odds ratio (OR) [95% confidence interval (CI)]. p-values < 0.05 were considered statistically significant. Statistical analysis was performed with StataBE v18.0 (StataCorp LLC, College Station, TX, USA) [7].

4. Results and Discussion

A total of 68 publications describing pioneering techniques in urology were identified (Appendix A). These included 16 isolated case reports and 52 case series. Among the case series, 22 involved small cohorts with 2 to 10 cases, while 30 featured larger cohorts with more than 10 cases. Initial analysis was performed by grouping publications in chronological ordinal groups, and ordinal logistical regression was performed. Pioneering urological techniques were then split into six discrete domains including uro-oncology (bladder), uro-oncology (prostate), uro-oncology (kidney), reconstructive urology (upper tract), reconstructive urology (lower tract), and endourology.
Prior to 1901, techniques in urology were published as solitary case reports (mean cases per publication [CPP] = 1) (Figure 1a). Publications from 1901 onwards demonstrated a gradual increase in cases per publication (R2 = 0.798, OR = 6.29 [95% CI: 2.57 to 10.02], p = 0.007) (Figure 1a). This can be largely attributed to the transformative nature of historical procedures allowing for the surgical technique itself to be a focus of the publication. Procedures such as open radical nephrectomy and open radical prostatectomy were considered transformative as they changed surgical management drastically. These procedures were widely adopted at the time, as their benefits were evident. In contrast, modifications to existing, widely adopted procedures often showed only incremental benefits. As such larger case series are often required to demonstrate the additional benefits derived from novel procedures and justify increased costs or surgical risks. A clear example was seen comparing the introduction of transvesical prostatectomy (1887, 1 case) to the Transurethral Resection of the Prostate (TURP) (1926, 46 cases) and to the Holmium Laser Enucleation of the Prostate (HoLEP) (1995, 110 cases) (Appendix A).
When split into distinct domains, the findings were more heterogenous (Figure 1b). Whilst the general trend was an increase in CPP with time, recent surgical innovations paired with technological innovations have not followed this. This is well demonstrated by endourological publications where CPP peaked at 110 for the period 1976–2000 and subsequently decreased to 12 CPP from 2001 onwards. This was due to the low number of cases published in the initial case series of recent endourological procedures paired with technological innovation for the treatment of benign prostatic hypertrophy (BPH) such as Urolift and the Greenlight Photovaporization of Prostate and Rezum (Appendix A). A similar pattern was seen in reconstructive urological procedures, with the highest CPP seen in the period 1951–2000.
Our results reveal that many transformative surgical techniques were initially reported as isolated case studies or small series, underscoring the primacy of innovation over publication volume. This observation highlights the need for flexible publication standards that emphasize methodological rigor and robust peer review rather than adherence to arbitrary thresholds such as minimum case numbers. While larger case series offer strong evidence for the safety and efficacy of novel techniques, they are not without limitations. The extended time required to accrue substantial cohorts, particularly in centers with lower procedural volumes, can delay the dissemination and clinical adoption of potentially groundbreaking innovations. Additionally, the financial and logistical burdens associated with conducting large-scale studies may disproportionately affect resource-limited settings, thereby restricting the diversity and inclusivity of contributions to the surgical literature.
The Idea, Development, Exploration, Assessment, Long-term (IDEAL) framework, introduced in 2009, provides a structured approach to the optimal generation of evidence for surgical innovation. It outlines five stages: Idea, Development, Exploration, Assessment, and Long-term, guiding the progression of a novel procedure from its initial description through evaluation and exploration to its long-term study [8]. The IDEAL framework adds significant value by improving the quality of evidence for new surgical interventions. It specifies the appropriate study designs and reporting requirements at each stage, ensuring robust evaluation and collective learning. Additionally, it helps to determine when to advance to higher levels of evidence, such as randomized clinical trials. By encouraging standardization and transparency, the framework promotes safe, efficient, and evidence-based surgical innovation [4,8]. The integration of frameworks such as IDEAL can significantly enhance the systematic evaluation of novel techniques. However, maintaining flexibility within the publication process remains crucial. Journals should evaluate each submission on its individual merits, employing rigorous peer review to address potential limitations inherent in smaller studies. This approach fosters an environment where innovation can progress without compromising patient safety or the scientific rigor essential to maintaining the integrity of the evidence base.
This study’s limitations include reliance on major databases and by selecting English-language-only publications. To mitigate this selection bias, the authors performed independent literature searches with multiple reviewers to reduce oversight and ensure consistency through centralized adjudication. A broad search strategy, using various databases (PubMed, Ovid, and Scopus) and diverse keywords, was employed to capture a wider range of pioneering techniques. Additionally, reference chasing and the inclusion of non-English publications aimed to minimize language bias. The inclusion criteria, developed with a senior urologist and cross-referenced with standard texts, ensured a comprehensive and rigorous search process, further addressing potential biases in study selection.

5. Conclusions

Safe and efficacious surgical innovation is essential for advancing the technical and technological aspects of surgery. Historical trends demonstrate that many transformative techniques were initially published with small case numbers, emphasizing the importance of early dissemination and peer review in fostering innovation. While the IDEAL framework offers a structured pathway for evaluating new techniques, its application must remain adaptable to accommodate diverse practice environments, including smaller or resource-limited centers. Imposing rigid publication requirements for large case series risks delaying the dissemination of promising innovations, thereby limiting timely peer feedback and potential patient benefits. A merit-based, balanced approach to publication criteria that prioritizes methodological rigor, adequate follow-up duration, and the potential impact of innovation will better serve the surgical community. Journals should continually reassess their criteria to promote timely and safe innovation without compromising patient outcomes or stifling creativity.

Author Contributions

Manuscript writing: all authors. Final approval of the manuscript: all authors. Accountable for all aspects of the work: all authors. All authors have read and agreed to the published version of the manuscript.

Funding

This research received no external funding.

Institutional Review Board Statement

Not applicable.

Informed Consent Statement

Not applicable.

Data Availability Statement

The original contributions presented in this study are included in the article. Further inquiries can be directed to the corresponding author.

Acknowledgments

We would like to thank Sunshine Coast University Hospital library staff for their tireless efforts in assisting authors with reference tracing and thorough historical tracing of original articles.

Conflicts of Interest

The authors declare no conflicts of interest.

Appendix A. Collated Data PDF

SNSurgical ProcedureNo. of CasesYearReference
Surgical Procedures with a Single Case Report
1Open simple nephrectomy for benign disease11869Simon [9]
2Open partial nephrectomy for benign disease11870Simon [9]
3Open partial nephrectomy for renal tumour11887Herczel et al. [10]
4Transvesical prostatectomy11887Belfield [11]
5Boari flap reimplantation of the ureter11947Ockerblad [12]
6Anderson-Hynes dismembered pyeloplasty11949Anderson et al. [13]
7Open radical nephrectomy11952Foley et al. [14]
8Reconstruction of the perineal urethra with a free full-thickness skin graft of the prepuce11953Presman et al. [15]
9Lich-Gregoir extravesical ureteral reimplantation11964Lich et al. [16]
10A penile flap procedure for the relief of meatal stricture11963Cohney [17]
11Transperitoneal laparoscopic nephrectomy11991Clayman et al. [18]
12Laparoscopic simple cystectomy11992Parra et al. [19]
13Laparoscopic partial nephrectomy for benign disease11993Winfield et al. [20]
14Retroperitoneal laparoscopic simple nephrectomy using a balloon dissector11993Gaur et al. [21]
15Laparoscopic dismembered pyeloplasty 11993Kavoussi [22]
16Retroperitoneal laparoscopic partial nephrectomy11994Gill [23]
Surgical procedures with 2–10 cases
1Rectal urinary diversion for exstrophy bladder81905Remedi [24]
2Ileal conduit urinary diversion21911Zaayer [25]
3One-stage operation for hypospadias71941Humby et al. [26]
4Open radical cystectomy 61949Marshall et al. [27]
5One stage urethroplasty with full-thickness skin graft61963Devine et al. [28]
6Orandi one-stage urethroplasty using penile skin flap101968Orandi [29]
7Ileocaecal continent urinary diversion71974Ashken [30]
8Meatal reconstruction71976Brannen [31]
9Quarty one-stage penile/preputial flap urethroplasty101983Quartey [32]
10Aesthetic repair of meatal stricture 51984De Sy [33]
11Reconstruction of the fossa navicularis51987Jordan et al. [34]
12Buccal mucosal graft for urethral reconstruction61992Bürger et al. [35]
13Laparoscopic dismembered pyeloplasty 51993Schuessler [36]
14Penile circular fasciocutaneous flap urethroplasty (McAninch)101993McAninch [37]
15Laparoscopic radical prostatectomy91997Schuessler [38]
16Robotic-assisted laparoscopic radical prostatectomy52001Pasticier [39]
17Percutaneous endopyeloplasty92002Gill [40]
18Photoselective vaporization of the prostate (PVP)102003Hai [41]
19Robotic radical nephrectomy52005Klingler [42]
20Rezūm: transurethral convective water vapor treatment for BPH72015Dixon [43]
21Modified orandi urethroplasty102015Goel [44]
22Transurethral ventral buccal mucosa graft inlay urethroplasty for distal penile stricture32016Nikolavsky [45]
Surgical procedures with >10 cases
1TURP461926Stern [46]
2Foley Y-V pyeloplasty201937Foley [47]
3Millin’s prostatectomy201945Millin [48]
4Vertical flap pyeloplasty121953Scardino et al. [49]
5Culp-DeWeed pyeloplasty271954Culp et al. [50]
6Politano-Leadbetter reimplantation141958Politano et al. [51]
7Ileal neobladder321958Camey [52]
8Burch colposuspension531961Burch [53]
9Lich-Gregoir extravesical technique271964Gregoir et al. [54]
10Omental pedicle graft in the repair and reconstruction of the urinary tract431967Turner-Warwick et al. [55]
11Two-stage urethroplasty using scrotal flap171968Blandy et al. [56]
12Free full-thickness skin graft urethroplasty601976Devine et al. [57]
13Cohen’s cross-trigonal ureteral reimplantation3151977Cohen [58]
14Open radical prostatectomy121983Walsh et al. [59]
15One-stage urethroplasty with oral graft201993El-Kasaby et al. [60]
16Snodgrass tubularized, incised plate urethroplasty for hypospadias161994Snodgrass [61]
17Holmium Laser Enucleation of the Prostate (HoLEP)1101995Gilling et al. [62]
18Two-stage repair of hypospadias6001995Bracka [63]
19Ventral onlay graft urethroplasty131996Morey et al. [64]
20Dorsal onlay graft urethroplasty (Barbagli)251996Barbagli et al. [65]
21Mesh graft urethroplasty201997Carr et al. [66]
22Endoscopic skin-graft urethroplasty531998Naudé [67]
23Dorsal inlay free graft urethroplasty (Asopa)122001Asopa et al. [68]
24Robotic radical cystectomy172003Menon et al. [69]
25Robotic partial nephrectomy132004Gettman et al. [70]
26Robotic-assisted laparoscopic dismembered pyeloplasty502005Patel [71]
27One side dorsal onlay buccal mucosa graft urethroplasty (Kulkarni)242009Kulkarni et al. [72]
28UroLift192011Woo et al. [73]
29Combined dorsal BMG and onlay penile skin flap urethroplasty for obliterative distal urethral strictures122011Gelman et al. [74]
30Non-transecting anastomotic bulbar urethroplasty222011Andrich et al. [75]

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Siuj 06 00022 g001aSiuj 06 00022 g001b
Figure 1. Historical analysis of pioneering techniques in urology. (a) Cases per publication total over all sub-specialties over time. Linear regression, R2 = 0.798, OR = 6.29 [95% CI: 2.57 to 10.02], p = 0.007. (b) Cases per publication per discipline (separate bar) over time.
Figure 1. Historical analysis of pioneering techniques in urology. (a) Cases per publication total over all sub-specialties over time. Linear regression, R2 = 0.798, OR = 6.29 [95% CI: 2.57 to 10.02], p = 0.007. (b) Cases per publication per discipline (separate bar) over time.
Siuj 06 00022 g001aSiuj 06 00022 g001b
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Sii, S.; Homewood, D.; Dittmer, B.; Nzembela, K.; Weerakoon, M.; O’Brien, J.S.; Bolton, D.; Lawrentschuk, N.; Corcoran, N.M.; Agarwal, D.K. Mapping the Shifting Landscape of Urological Innovation. Soc. Int. Urol. J. 2025, 6, 22. https://doi.org/10.3390/siuj6010022

AMA Style

Sii S, Homewood D, Dittmer B, Nzembela K, Weerakoon M, O’Brien JS, Bolton D, Lawrentschuk N, Corcoran NM, Agarwal DK. Mapping the Shifting Landscape of Urological Innovation. Société Internationale d’Urologie Journal. 2025; 6(1):22. https://doi.org/10.3390/siuj6010022

Chicago/Turabian Style

Sii, Samuel, David Homewood, Brendan Dittmer, Kalonji Nzembela, Mahesha Weerakoon, Jonathan S. O’Brien, Damien Bolton, Nathan Lawrentschuk, Niall M. Corcoran, and Dinesh K. Agarwal. 2025. "Mapping the Shifting Landscape of Urological Innovation" Société Internationale d’Urologie Journal 6, no. 1: 22. https://doi.org/10.3390/siuj6010022

APA Style

Sii, S., Homewood, D., Dittmer, B., Nzembela, K., Weerakoon, M., O’Brien, J. S., Bolton, D., Lawrentschuk, N., Corcoran, N. M., & Agarwal, D. K. (2025). Mapping the Shifting Landscape of Urological Innovation. Société Internationale d’Urologie Journal, 6(1), 22. https://doi.org/10.3390/siuj6010022

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