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Newer instruments minimize incisions, incision size, and financial impact.

Robotic miniaturization: Reducing the surgical footprint

The FDA has accepted a Biologics License Application (BLA) seeking approval of nivolumab (Opdivo) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), or subcutaneous nivolumab, for the treatment of patients with all previously approved solid tumor indications for nivolumab as a monotherapy, monotherapy maintenance following completion of combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Nivolumab is currently approved under several indications, including in combination with ipilimumab for the first-line treatment of patients with intermediate- or poor-risk advanced renal cell carcinoma (RCC), in combination with cabozantinib for the first-line treatment of patients with advanced RCC, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy, and in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024.

 According to a news release from Bristol Myers Squibb,

 approval of the formulation would make it the first and only subcutaneously administered PD-1 inhibitor.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in the news release.

 “Opdivo is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30-to-60-minute infusion.”

The BLA submission is supported by findings from the phase 3 CheckMate-67T trial (NCT04810078), in which subcutaneous nivolumab met the study’s co-primary end points by demonstrating noninferiority to intravenous (IV) nivolumab regarding time average nivolumab serum concentration over 28 days (C

; geometric mean ratio [GMR}, 2.098; 90% CI, 2.001-2.200) and minimum serum concentration at a steady state (C

Data from the study, which were presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California,

 also showed that subcutaneous nivolumab demonstrated noninferiority to IV nivolumab in the key powered secondary end point of objective response rate (ORR). Specifically, the subcutaneous arm demonstrated an ORR of 24.2% (95% CI, 19.0-30.0) per blinded independent central review (BICR), compared with 18.2% (95% CI, 13.6-23.6) in the IV arm.

The safety profile for subcutaneous nivolumab was consistent with that of the IV formulation. Among patients who received the subcutaneous formulation, 8.1% experienced injection-site reactions, with all being low-grade and transient. Deaths due to study drug toxicity occurred in 3 patients in the subcutaneous arm and 1 patient in the IV arm. Most deaths that occurred during the study were due to disease progression.

In total, the phase 3, open-label CheckMate-67T trial enrolled 495 patients with advanced or metastatic ccRCC who had received prior systemic therapy. Patients were randomly assigned 1:1 to receive 1200 mg subcutaneous nivolumab plus rHuPH20 every 4 weeks (n = 248) or to 3 mg/kg IV nivolumab every 2 weeks (n = 247) for up to 2 years of treatment or until disease progression, unacceptable toxicity, withdrawal, or death.

The co-primary pharmacokinetic end points for noninferiority testing were C

 of subcutaneous nivolumab vs IV nivolumab. The key secondary end point was ORR per BICR.

Final completion of the CheckMate-67T study is expected in January 2026.

1. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Bristol Myers Squibb. May 6, 2024. Accessed May 7, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

2. Bristol Myers Squibb announces updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Published online and accessed May 21, 2024. https://investors.bms.com/iframes/press-releases/press-release-details/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

3. George S, Bourlon TB, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. 

4. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Last updated March 1, 2024. Accessed May 7, 2024. https://clinicaltrials.gov/study/NCT04810078

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024. 

News

FDA accepts BLA for subcutaneous nivolumab in solid tumors

A 35-year-old male from Sudan was hospitalized with a right obstructing 1-cm ureteral stone seen on KUB. The KUB also revealed curvilinear calcification in the bladder wall. The patient was taken to the operating room for ureteroscopy and laser lithotripsy.

During cystoscopy, a rim of calcification was seen along the right ureteric ridge (figure 1a). A biopsy of this area was taken with the pathology shown in figure 1b.

B. Squamous cell carcinoma of the bladder

A 35-year-old male from Sudan presented with a 1-cm obstructing ureteral stone and curvilinear calcification in the bladder wall, as seen on KUB imaging. The patient underwent ureteroscopy and laser lithotripsy. During cystoscopy, calcification was observed along the right ureteric ridge. A biopsy was performed on this area to further investigate the pathology. The findings from the biopsy are crucial for understanding the underlying condition contributing to the calcification and obstruction, which may have implications for the patient's treatment and management.

A 35-year-old male from Sudan was hospitalized with a right obstructing 1-cm ureteral stone seen on KUB. The KUB also revealed curvilinear calcification in the bladder wall. The patient was taken to the operating room for ureteroscopy and laser lithotripsy. During cystoscopy, a rim of calcification was seen along the right ureteric ridge. What is the diagnosis?

Residents Corner

Quiz: Sandy patch on cystoscopy

-selective tyrosine kinase inhibitor, demonstrated initial efficacy while maintaining a favorable tolerability profile in patients with metastatic urothelial carcinoma (mUC), according to interim data from the phase 1/2 SURF301 trial (NCT05544552).

The data were presented at the 36th EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain.

 alterations are known to drive tumor biology in a subset of urothelial cancer. While pan-

 inhibitors have demonstrated benefit and are approved for use in 

-altered urothelial cancer, they are associated with multiple intolerable on-target toxicities that limit their clinical utility,” said Ben Tran, MD, associate professor at the Peter McCallum Cancer Centre in Melbourne, Australia, in a news release on the data.

 “There remains an unmet need to deliver improved precision medicine for urothelial cancer patients that allow patients to not only live longer, but live better.”

In total, 41 patients were included in the preliminary analysis at the time of data cutoff. For the trial, TYRA-300 was evaluated across 6 dose levels, ranging from 10 mg to 120 mg once daily.

-altered mUC, anti-tumor activity was observed across all patients who were treated at the dose levels of 90 mg and higher. In these cohorts, 54.5% of patients (6 of 11) achieved a partial response. This consisted of 5 patients (50%) in the 90 mg cohort and 1 patient (100%) in the 120 mg cohort. Three partial responses were still ongoing at the time of data report.

The disease control rate, consisting of partial response plus stable disease, was 100% among patients with mUC who received TYRA-300 at 90 mg or higher.

According to the authors, the therapy was also generally well-tolerated. There were 4 (10%) serious adverse events (AEs) related to TYRA-300 across all dose levels (10 mg to 120 mg). Of these, 1 was a grade 3 dose-limiting toxicity in the 90 mg cohort, and 2 were grade 3 treatment-related AEs (TRAEs) of increased ALT in the 90 mg cohort, 1 of which led to the discontinuation of treatment.

Overall, AEs of any grade occurred in 78% of patients (n = 32), and AEs of grade 3 or higher occurred in 20% of patients (n = 8). There were no grade 4 or higher TRAEs. No dose-limiting toxicities were reported among patients in the highest dose cohort of 120 mg at the time of data cutoff.

“These first results from the phase 1 clinical trial of TYRA-300 show compelling activity in patients whose cancer has progressed despite being heavily treated with other therapies previously,” said Timothy A. Yap, MBBS, PhD, FRCP, from the University of Texas MD Anderson Cancer Center in Houston and co-chair of the EORTC-NCI-AACR Symposium.

 “The fact that TYRA-300 seems able to specifically target cancers with 

 mutations or fusions, with fewer side effects than other drugs, gives us hope that patients with hard-to-treat advanced bladder and other cancers that also have 

 mutations or fusions may be able to benefit from a kinder and more effective therapy once these results have been validated in further clinical trials.”

Overall, the ongoing SURF301 trial is enrolling participants with mUC and other solid tumors who harbor 

 gene alterations. At the time of data cutoff, 61% of patients (n = 25) in the trial had mUC. Among all patients with 

-altered mUC, 76% had received at least 3 prior lines of therapy. 

The median age among all participants was 66 years. Enrollment for the trial is taking place at 21 clinical trial sites across the United States, Europe, and Australia.

For phase 1 of the study, patients will receive TYRA-300 at dose levels ranging from 10 mg – 120 mg once or twice daily. In phase 2, patients will receive TYRA-300 at the recommended phase 2 dose level determined in the first phase.

The primary end points for phase 1 include the incidence of dose-limiting toxicities and adverse events, as well as other safety parameters. Secondary end points include pharmacokinetic parameters, overall response rate, duration of response, duration of complete response, time to response, and progression-free survival.

Phase 1 of the study remains ongoing to determine the maximum tolerated dose.

"The initial results from TYRA-300 are very encouraging. I believe TYRA-300 has the potential to be a next generation targeted therapy, with high selectivity for 

 “These early data provide support that TYRA-300 can deliver improved anti-tumor activity and tolerability for our 

-altered urothelial cancer patients. TYRA-300 has real potential to improve outcomes, and I look forward to its continued development in all 

1. Tran B, Zhang A, Hansen A, et al. Preliminary safety and anti-tumor activity of TYRA-300, a highly selective FGFR3 inhibitor, in participants with advanced solid tumors with activating FGFR3 mutations/fusions (SURF301). Presented at: 36th EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics. October 23-25, 2024. Barcelona, Spain. Abstract 500LBA

2. Tyra Biosciences reports interim clinical proof-of-concept data for TYRA-300, an investigational oral FGFR3-selective inhibitor, in phase 1/2 SURF301 study in patients with metastatic urothelial cancer (mUC). News release. Tyra Biosciences, Inc. October 24, 2024. Accessed October 31, 2024. https://ir.tyra.bio/news-releases/news-release-details/tyra-biosciences-reports-interim-clinical-proof-concept-data

3. Patients with advanced bladder cancer with alterations in the FGFR3 gene respond well to investigational drug, TYRA-300. News release. October 25, 2024. Accessed October 31, 2024. https://event.eortc.org/ena2024/2024/10/25/patients-with-advanced-bladder-cancer-with-alterations-in-the-fgfr3-gene/

4. Safety and preliminary anti-tumor activity of TYRA-300 in advanced urothelial carcinoma and other solid tumors with FGFR3 gene alterations (SURF301). ClinicalTrials.gov. Updated October 3, 2024. Accessed October 31, 2024. https://clinicaltrials.gov/study/NCT05544552

TYRA-300, an investigational FGFR3-selective tyrosine kinase inhibitor, shows promising efficacy and tolerability in metastatic urothelial carcinoma (mUC) patients, according to interim data from the SURF301 trial. The trial demonstrated a 54.5% partial response rate in patients receiving doses of 90 mg or higher, with a 100% disease control rate. The therapy was generally well-tolerated, with no grade 4 or higher treatment-related adverse events. These findings suggest TYRA-300's potential as a targeted therapy for FGFR3-altered cancers, warranting further clinical investigation.

Anti-tumor activity was observed across all patients with FGFR3-altered metastatic urothelial carcinoma who were treated at the dose levels of 90 mg and higher. 

TYRA-300 shows encouraging safety, efficacy in FGFR3+ metastatic urothelial carcinoma

Recent data presented at Pelvic Floor Disorders Week 2024 showed no significant association between the use of vaginal estrogen for the management of genitourinary syndrome of menopause (GSM) and subsequent major adverse cardiovascular events (MACE).

An additional study presented at the meeting showed no significant association between the use of systemic (non-vaginal) estrogen for vasomotor symptoms of menopause (VMS) and subsequent venous thromboembolic events (VTE).

According to the authors, vaginal estrogen therapies contain a listed contraindication for a history of myocardial infarction and stroke, as well as a black-box warning for increased risk of deep vein thrombosis. The current studies sought to assess the risk of these events in women who did and did not receive vaginal or systemic estrogen within 1 year following their diagnosis.

In total, the retrospective cohort analysis comparing vaginal estrogen and subsequent MACE included 549,925 women from the TriNetX database who received a diagnosis of GSM between April 2004 and April 2024. Among all patients, 53.8% received vaginal estrogen.

After propensity score matching, each study arm included 65,243 high-risk women (a diagnosis of MACE between 3 and 24 months prior to first GSM diagnosis) and241,326 low-risk women (no history of MACE). A subsequent MACE diagnosis included myocardial infarction, stroke, and cardiovascular death.

Among all high-risk women, a subsequent MACE diagnosis occurred in 23% of patients who received vaginal estrogen vs 23% of patients who were not treated with vaginal estrogen (HR, 0.990; 95% CI, 0.936 to 1.048; 

 = .423). In low-risk women, a subsequent MACE diagnosis occurred in 6.2% of patients who received vaginal estrogen vs 7.4% of patients who did not receive vaginal estrogen (HR, 0.938; 95% CI, 0.918 to 0.959; 

Similar results were seen when comparing the use of systemic estrogen for VMS and subsequent VTE.

In total, the retrospective study identified 526,144 women from the TriNetX database who received a diagnosis of VMS between April 2004 and April 2024. Among these patients, 7.4% received systemic estrogen. After propensity score matching, each study arm included564 high-risk women (a diagnosis of tobacco use by ICD-10 code any time prior to first VMS diagnosis) and 38,583 low-risk women (no history of prior tobacco use).

Among all high risk-women, subsequent VTE occurred in 2.0% of patients who received systemic estrogen compared with 2.8% of patients who did not receive systemic estrogen (HR, 0.774; 95% CI, 0.359 to 1.670; 

 = .750). Among low-risk women, subsequent VTE was experienced by 1.6% of patients who received systemic estrogen compared with 2.1% of patients who did not receive systemic estrogen (HR, 0.986; 95% CI, 0.887 to 1.097; 

“These findings support the safety of vaginal estrogen for treatment of local menopause symptoms, even in high-risk women,” concluded lead author Gabriella M. Rustia, MD, a female pelvic medicine and reconstructive surgery fellow at University Hospitals in Cleveland, Ohio, in correspondence with 

. “Further research should elucidate current practice patterns with systemic hormone replacement specific to route and dose of administration such as patch or oral routes.”

1. Rustia GM, Rahman A, Rhodes S, Sheyn D. Major adverse cardiovascular events with and without vaginal estrogen therapy. Presented at: Pelvic Floor Disorders Week 2024. October 22-25, 2024. Washington, DC

2. Rustia GM, Rhodes S, Sheyn D. Rate of venous thromboembolic events with and without systemic estrogen therapy. Presented at: Pelvic Floor Disorders Week 2024. October 22-25, 2024. Washington, DC

Recent studies presented at Pelvic Floor Disorders Week 2024 indicate no significant link between vaginal estrogen use for genitourinary syndrome of menopause (GSM) and major adverse cardiovascular events (MACE), nor between systemic estrogen for vasomotor symptoms (VMS) and venous thromboembolic events (VTE). The retrospective cohort analysis involved over half a million women from the TriNetX database. Results showed similar MACE and VTE rates in both high-risk and low-risk groups, regardless of estrogen therapy. These findings suggest the safety of estrogen therapies, even in high-risk populations.

“These findings support the safety of vaginal estrogen for treatment of local menopause symptoms, even in high-risk women,” says Gabriella M. Rustia, MD.

Vaginal estrogen for GSM not associated with major adverse cardiovascular events 

Two-year data from the pivotal OASIS trial (NCT03596671) demonstrate sustained efficacy of the Revi System, an implantable tibial neuromodulation system for patients with urgency urinary incontinence (UUI).

The findings were presented by Cindy L. Amundsen, MD, at Pelvic Floor Disorders Week 2024.

"These data show that the therapeutic benefits of the Revi System are not only sustained over time but also result in consistently high patient satisfaction and a favorable safety profile, representing a meaningful technological advancement in the treatment of urgency urinary incontinence,” said Amundsen, a urogynecologist at Duke University in Durham, North Carolina, in a news release on the findings.

Of the 151 patients initially enrolled in the trial, 97 completed the 24-month assessment. Of these, 79% experienced a response to therapy, and 56% achieved at least a 75% reduction in UUI episodes. The therapeutic response rate was 79%, which is comparable to the rates seen at 6 months (78%) and 12 months (82%).

Additionally, 97% of patients indicated that they were satisfied with the therapy, and 80% indicated that they felt “much better” or "very much better” at 2-year follow-up, per the Patient Global Impression of Improvement questionnaire.

Regarding safety, no serious device- or procedure-related adverse events were observed at 24 months. There was 1 delayed surgical site-related adverse event attributed to an “exuded non-absorbable, braided suture, resulting in a superficial infection,” which did not require explantation of the device.

The authors noted, “Subjects that completed both the 6-month assessment (n=144) and the 24-month assessment (n=97) had similar demographics and results at the 6-month visit, indicating that results at 24-months are representative of the overall study population.”

"These findings reinforce the durability of significant response and high patient satisfaction of the Revi system, highlighting its status as the leading solution for implantable tibial neuromodulation,” said Roger Dmochowski, MD, MMHC, FACS, chief medical officer of BlueWind Medical, in the news release.

 “As physicians increasingly become aware of Revi as an important UUI treatment option, we are excited to share these results with the global community of healthcare professionals dedicated to advancing care for incontinence."

In total, the prospective, multicenter, single-arm, open-label OASIS trial enrolled and implanted 151 female patients with UUI across clinical trial sites in the United States and Europe.

 Of those, 144, 140, and 97 patients completed the 6-, 12-, and 24-month visits, respectively. At baseline, patients demonstrated an average of 4.8 UUI episodes per day (SD, 2.9) and 10 voids per day (SD, 3.3). The average age of participants was 58.8 years (SD, 12.5).

Patients were eligible for enrollment if they experienced at least 9 UUI episodes on a 7-day diary. For the study, participants stimmed for approximately 30 minutes twice daily.

The primary efficacy end point was the proportion of responders to therapy, defined as at least a 50% improvement in the average number of UUI episodes at 6 months. The primary safety end point was the incidence of adverse events from implantation at 12 months following activation of the device. Secondary end points included the proportion of responders, defined as at least a 50% improvement in UUI episodes or severe UUI episodes at 12 months, and the severity of leaks.

the FDA granted a de novo marketing authorization

 to the Revi System based on initial 6- and 12-month data from the OASIS trial.

 showed that the study met its primary end point with 76.4% of patients in the intent-to-treat population demonstrating at least a 50% reduction in UUI episodes, which reached statistical significance in comparison with the predefined performance goal (

 < .0001). At 12-month follow-up, the clinical response rate was 78.4%.

In patients who completed 12-month diaries (n = 139), 82% achieved at least a 50% reduction in UUI episodes and 66.9% achieving at least a 75% reduction. Further, 37.8% and 50% of patients classified as dry on at least 3 consecutive diaries at 6- and 12-month follow-up, respectively.

Regarding safety, no procedure- or device-related serious adverse events (AEs) were reported. Additionally, no patients required surgical reintervention or revisions due to implant migration, lead breakage, or battery replacement. In total, 15 serious AEs and 285 AEs were reported.

1. Amundsen C, Heesakkers J, Toozs-Hobson P, et al. 2 year results: Revi therapy, implanted neuromodulator for urgency incontinence. Presented at: Pelvic Floor Disorders Week 2024. October 22-25, 2024. Washington, DC

2. Two-year Revi therapy data reinforce sustained efficacy and safety of implantable tibial neuromodulation in managing urgency urinary incontinence. BlueWind Medical, Ltd. October 24, 2024. Accessed October 25, 2024. https://www.businesswire.com/news/home/20241024044110/en/Two-Year-Revi%C2%AE-Therapy-Data-Reinforce-Sustained-Efficacy-and-Safety-of-Implantable-Tibial-NeuroModulation-in-Managing-Urgency-Urinary-Incontinence

3. Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, et al. A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence. 

4. BlueWind Medical's Revi System secures U.S. FDA De Novo Classification grant for the treatment of urgency incontinence. News release. BlueWind Medical. August 17, 2023. Accessed October 25, 2024. https://www.prnewswire.com/news-releases/bluewind-medicals-revi-system-secures-us-fda-de-novo-classification-grant-for-the-treatment-of-urgency-incontinence-301903199.html?tc=eml_cleartime

The OASIS trial's 2-year data confirm the Revi System's sustained efficacy and safety for urgency urinary incontinence (UUI). The trial involved 151 patients, with 97 completing the 24-month assessment. Results showed a 79% therapeutic response rate, with 56% achieving a 75% reduction in UUI episodes. Patient satisfaction was high, with 97% satisfied and 80% feeling significantly improved. No serious adverse events were reported. The Revi System, which received FDA de novo marketing authorization, represents a significant advancement in implantable tibial neuromodulation for UUI treatment.

The therapeutic response rate was 79% at 24 months, which is comparable to the rates seen at 6 months (78%) and 12 months (82%). 

OASIS: Efficacy of Revi System for urgency incontinence maintained at 2 years

 found that certain racial and ethnic minority groups are misrepresented in urolithiasis clinical trials compared with the overall urolithiasis population in the United States.

For the study, the investigators assessed clinical trials indexed on PubMed from 2000 to 2022. Of the 180 urolithiasis clinical trials performed in the US during that time period, 40 (22%) reported race and ethnicity of participants and 104 (58%) trials reported sex of participants. Given that only 1 in 4 published trials reported race and ethnicity of participants, the authors note that improved reporting practices are needed to better reflect the diversity of the urolithiasis population.

Demographic data obtained from the included studies were then compared to the kidney stone prevalence reported by the National Health and Nutrition and Examination Survey from 2015 to 2018. A representation quotient was calculated to determine the concordance of representation on race/ethnicity and on sex, stratified by geographic location, study type, and funding source.

Overall, data from the study showed that both male and female participants were well represented in clinical trials, with representation quotients of 0.97 and 1.02, respectively.

Regarding race and ethnicity, data showed that Hispanic patients were consistently underrepresented in clinical trials, with a representation quotient of 0.46. Conversely, Black participants tended to be overrepresented, with a representation quotient of 1.84. The representation quotients for Asian American and Pacific Islander patients, White patients, and patient of mixed/other ethnicity was 1.06, 1.04, and 0.34, respectively.

When stratified by geographic location, the most proportional enrollment in clinical trials was seen among studies completed in the Western section and in multi-institutional trials. Trials completed in the South Central and Southeastern Sections tended to underrepresent Hispanic patients and those of mixed/other ethnicity.

Trial enrollment was similar when stratified by study type. When looking at funding source, trial that were industry funded tended to have more diverse enrollment compared with those that were academic-funded.

Co-author Amy M. Reed, MD, Capt, USAF, MF, an endourology and laproscopic surgery fellow at Vanderbilt University Medical Center in Nashville, Tennessee, explained in correspondence with 

®, “We feel our findings further urologic knowledge in 2 major ways. First, we found decreased enrollment of high-risk stone populations. By identifying enrollment trends within urolithiasis trials, we can work on understanding barriers to enrollment and how culture and socioeconomic factors may impact this community. Second, by using final published manuscripts, we highlight areas of improvement for communication of results by investigators and authors. Only 25% of urolithiasis trials publish these data and a significant number of those trials publish incomplete or reductive participant information. Understanding these limitations is important because clinical trial results inform the medical community to draw accurate conclusions and apply generalizable results to clinical practice.”

As such, the authors concluded, “Investigators should prioritize inclusive recruitment and improve reporting practices to accurately reflect the diversity of the urolithiasis population.”

1. Reed AM, Hsi RS. Diversity, equity, and inclusion in urolithiasis clinical trials: Representative enrollment by race, ethnicity, and sex. 

. 2024;11(4):685-691. doi:10.1097/UPJ.0000000000000595

A study in Urology Practice highlights the misrepresentation of racial and ethnic minorities in urolithiasis clinical trials in the US. Analyzing 180 trials from 2000 to 2022, only 22% reported race and ethnicity, and 58% reported sex. Hispanic patients were underrepresented, while Black participants were overrepresented. Geographic location and funding source influenced diversity, with industry-funded trials showing more diverse enrollment. The study emphasizes the need for inclusive recruitment and improved reporting to better reflect the urolithiasis population's diversity and ensure accurate, generalizable clinical trial results.

Data showed that Hispanic patients were consistently underrepresented in clinical trials, while Black participants tended to be overrepresented.

Justin Badal, MD

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