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How Do We Increase the Level of Evidence in Urological Reconstruction?
By: Benjamin N. Breyer, MD; Bradley A. Erickson, MD, MS | Posted on: 01 Oct 2022
Reconstruction, as its own specialty within urology, has blossomed over the last few decades. The conditions the reconstructive urologist treats, and the repertoire of techniques used, have grown significantly and now include robotics, upper and lower tract reconstruction, gender-affirming surgery, transitional (pediatric to adult) care, and cancer survivorship. Rather than a handful of specialized centers performing complex reconstruction, many programs across the country now have multiple reconstructive urologists, allowing many to become specialists within the subspecialty (eg gender-affirming, prosthetics). Our field now has more than 20 Society of Genitourinary Reconstructive Surgeons (GURS)-sponsored fellowship programs that are training the next generation of reconstructive urologists and wherever a new reconstructive urological program or reconstructive urologist begins, a population of previously underserved patients is usually there to greet them.
The next phase of reconstructive urological growth will need to see an elevation in the clinical and basic science research we undertake. In a recent analysis of the top cited papers in urethral reconstruction, the condition in which the majority of reconstructive research has been performed, nearly half of the papers were descriptive case series, with only 5% being randomized controlled trials (RCTs).1 Furthermore, the evidence of these studies is uniformly low, with 68% being level III and none reaching level IA evidence.
The reasons for the lack of strong evidence have much to do with the types of conditions reconstructive urologists manage: complex, rare, heterogeneous conditions that are difficult to categorize, and thus, difficult to generate large enough cohorts for randomization. Development of classification systems, such as those developed for urethral stricture disease2 and adult acquired buried penis,2 will help us combine observational data from multiple centers and should be pursued for other reconstructive conditions. However, agreement on surgical outcome end points will be an additional necessary step before any meaningful trial can be conducted, whether those end points be anatomical in nature (eg recurrence of a stricture), functional (improved urine flow), cosmetic (penile appearance), or a combination of all three.
Unfortunately, randomizing surgical techniques is historically challenging given the rapid pace of surgical innovation and how often individual surgeons change their techniques based on real-time and anecdotal feedback.3 Furthermore, once time and resource-consuming surgical RCTs are completed, the field has often already moved on (eg Burch colposuspension vs autologous sling).4 Challenges with recruitment have also hindered prior RCT efforts in reconstructive urology, as was recently seen in the Scandinavian study randomizing men with bulbar urethral strictures to graft versus excisional/anastomotic urethroplasty.5 These recruitment challenges should not be minimized and can be attributed to both patient and surgeon hesitancy to perform a “new” or “unproven” surgical procedure that is usually irreversible and with an outcome often dependent on surgeon experience. Rethinking how surgical clinical trials should and can be performed when surgeon and patient equipoise (ie genuine uncertainty within the expert medical community on the optimal approach for a certain medical condition)6 is not present remains a major hurdle to surgical RCTs.
GURS has been a nascent supporter of higher-quality research in reconstructive urology. These early efforts include holding the first specialty-specific 3-day academic congress in September in Montreal and developing a formal relationship with Urology, the “Gold Journal,” to become the preferred landing spot for high impact (if not high-quality), reconstructive literature. GURS is also providing grants and infrastructure support to members to perform research, similar to the Sexual Medicine Society of North America or the Society of Urologic Oncology. Furthermore, efforts for existing oncologic research infrastructures to recognize oncologic-adjacent reconstructive urological conditions, such as incontinence, pelvic radiation disease, and urethral/bladder neck stricture, as cancer survivorship conditions just as worthy of study as primary treatment may open the door for more funding opportunities and collaborations.
As the clinical scope of our field grows and evolves, improved research quality is critically needed to drive better care and quality. It’s paramount for the next generation of reconstructive urologists to be supported to engage in high-quality scholarship with appropriate training, mentoring, and funding. It is an exciting time to be a researcher and educator in reconstructive urology and we look forward to seeing our field continue to blossom.
- Lee AW, Ramstein J, Cohen AJ, Agochukwu-Mmonu N, Patino G, Breyer BN. The top 100 cited articles in urethral reconstruction. Urology. 2020;135:139-145.
- Flynn KJ, Vanni AJ, Breyer BN, Erickson BA. Adult-acquired buried penis classification and surgical management. Urol Clin North Am. 2022;49(3):479-493.
- Erickson BA, Flynn KJ, Hahn AE, et al. Development and validation of a male anterior urethral stricture classification system. Urology. 2020;143:241-247.
- Robinson NB, Fremes S, Hameed I, et al. Characteristics of randomized clinical trials in surgery from 2008 to 2020: a systematic review. JAMA Netw Open. 2021;4(6):e2114494.
- Albo ME, Richter HE, Brubaker L, et al. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007;356(21):2143-2155.
- Nilsen OJ, Holm HV, Ekerhult TO, et al. To transect or not transect: results from the Scandinavian Urethroplasty Study, a multicentre randomised study of bulbar urethroplasty comparing excision and primary anastomosis versus buccal mucosal grafting. Eur Urol. 2022;81(4):375-382.
- Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317(3):141-145.