30-Second Takeaway
- Pivotal device trials rarely embed structured equity analyses, limiting external validity.
- Vasectomy reversal patency and sperm concentration at 1 year vary substantially by surgeon.
Week ending June 13, 2026
Grand Rounds: Selected recent evidence affecting urology practice
Pivotal device trials infrequently integrate equity, limiting representativeness.
This scoping review of 74 pivotal medical device investigations found most were randomized trials but rarely incorporated equity frameworks into design or analysis. Age and sex were reported but used in subgroup analyses in only 18.9% and 14.8% of studies, respectively; race/ethnicity appeared in 35.1% of reports. Only 9.5% reported additional PROGRESS-Plus variables, and explicit EDI framing occurred in 2.7% of studies. Recruitment was predominantly clinic-based, and no studies performed population benchmarking or representativeness analyses, limiting external validity.
Vasectomy reversal outcomes vary markedly by surgeon and over time.
In 4,568 men across eight centers, 1‑year patency rates among surgeons ranged from 54%–93% (median 82%). Median sperm concentration at 1 year varied widely (surgeon medians 0–18.5 million/mL; overall median 10.3 million/mL). Sperm patency and concentrations declined over time but showed surgeon-dependent patterns and paradoxical correlations with vasectomy duration. Patients who had testing beyond 1 year had poorer outcomes, suggesting late-testing cohorts may overrepresent failures.
Salvia miltiorrhiza extract reduced IPSS more than saw palmetto in a 12‑week pilot.
In a randomized pilot of 30 men, 400 mg SAGX daily produced greater IPSS reduction than 320 mg saw palmetto over 12 weeks (p=0.031). Improvement was concentrated in storage symptoms and LUTS-related quality of life; erectile function also improved with SAGX. Adverse events were mild, transient, and occurred less frequently with SAGX. This small pilot is hypothesis-generating and not definitive for routine clinical use.
References
Numbered in order of appearance. Click any reference to view details.
Additional Reads
Optional additional studies from this edition.