Trial Domain Design · Year
▸ ATLAS For first-line nonsurgical SUI, pelvic-floor muscle training edges the pessary early on; combining them adds little — anchors conservative-therapy counseling. Stress Incontinence RCT · 2010
▸ OPUS A prophylactic sling at prolapse repair lowers postoperative urinary incontinence (a composite of stress, urgency and mixed incontinence, not SUI alone; NNT about 6 at 12 months) but adds adverse events — a trade-off to discuss, not a default. Stress Incontinence RCT · 2012
▸ SIMS The mini-sling, done under local anesthesia, is a legitimate noninferior alternative to the standard midurethral sling — useful when avoiding a retropubic or transobturator passage matters. Stress Incontinence Noninferiority RCT · 2022
▸ SISTEr The autologous fascial sling is more effective than Burch, at the cost of more postoperative morbidity — it remains the durable benchmark, especially for complex and revision cases. Stress Incontinence RCT · 2007
▸ TOMUS Objective success at 12 months was equivalent between routes; subjective equivalence was not established. The complication profiles differ, so the route is chosen by patient anatomy and risk tolerance rather than efficacy. Stress Incontinence Equivalence RCT · 2010
▸ VALUE Routine preoperative urodynamics is unnecessary in uncomplicated stress-predominant incontinence — it can be skipped before a sling. Stress Incontinence Noninferiority RCT · 2012
▸ Ward-Hilton (TVT vs Colposuspension) The trial that established the midurethral sling (TVT) as equivalent to the old gold-standard colposuspension — the pivot that made the sling the default SUI operation worldwide. Stress Incontinence RCT (multicenter) · 2002
▸ ESTEEM Layering behavioral/pelvic-floor therapy onto a sling gives a small additional benefit for mixed incontinence — one of the few trials to study this neglected group head-on. Mixed Incontinence RCT · 2019
▸ ABC Botox and anticholinergics reduce urgency incontinence about equally; Botox achieves more complete dryness but at the price of UTI and transient retention. OAB / Urgency Incontinence RCT (double-blind, double-placebo) · 2012
▸ ARTISAN-SNM Brought the long-lived rechargeable SNM device to market — the same neuromodulation benefit (cf. ROSETTA, InSite) on a battery rated for ~15 years rather than ~4–5. OAB / Urgency Incontinence Prospective multicenter trial · 2020
▸ EMPOWUR The pivotal trial behind the second β3-agonist (vibegron) for OAB — an alternative to mirabegron with once-daily dosing and few anticholinergic effects. OAB / Urgency Incontinence RCT (double-blind, placebo + active control) · 2020
▸ Ginsberg NDO Trial The phase-3 evidence behind FDA approval of Botox 200 U for neurogenic detrusor overactivity; 200 U is the dose (300 U adds risk, not efficacy). Counsel every patient about the need for CIC. Complements ABC/ROSETTA, which address idiopathic OAB. OAB / Urgency Incontinence RCT (double-blind, placebo-controlled) · 2012
▸ InSite Level-1 evidence that sacral neuromodulation outperforms continued drug therapy for OAB — supports moving to SNM rather than cycling further antimuscarinics/β3 agonists. OAB / Urgency Incontinence RCT (multicenter) · 2015
▸ Nitti OAB Trial The pivotal trial behind FDA approval of Botox 100 U for idiopathic OAB (the dose for non-neurogenic disease — distinct from the 200 U used for neurogenic DO in the Ginsberg trial). OAB / Urgency Incontinence RCT (double-blind, placebo-controlled) · 2013
▸ OASIS (Revi) The trial behind the FDA-authorized Revi implantable tibial neuromodulation device — usable without prior failure of conservative therapy, expanding the neuromodulation menu beyond sacral and percutaneous tibial routes. OAB / Urgency Incontinence Prospective pivotal study · 2024
▸ OrBIT In this 100-person, 12-week randomized trial, PTNS and tolterodine ER had similar diary improvements; more PTNS participants reported cure or improvement (79.5% vs 54.8%). Equivalence beyond 12 weeks was not tested. OAB / Urgency Incontinence RCT · 2009
▸ ROSETTA For refractory urgency incontinence, Botox 200 U and sacral neuromodulation are both effective — choose by side-effect tolerance (UTI/CIC vs device reoperation), not raw efficacy. OAB / Urgency Incontinence RCT (open-label) · 2016
▸ SUmiT The randomized, sham-controlled SUmiT trial showed greater patient-reported improvement with PTNS than sham at week 13. PTNS is a drug-free minimally invasive OAB option; the 2024 AUA/SUFU guideline permits its use without prior therapy trials through shared decision-making (Expert Opinion). OAB / Urgency Incontinence RCT (double-blind, sham-controlled) · 2010
▸ CAPABLe In women with fecal incontinence and normal stool consistency, this 24-week trial found no significant advantage for loperamide over placebo or manometry-assisted biofeedback over education. Constipation was reported with loperamide. Fecal Incontinence RCT (2×2 factorial) · 2019
▸ Altman (Nordic TVM) Anterior mesh repairs are anatomically more durable than native-tissue colporrhaphy but carry mesh-specific harms — part of the evidence trail leading to the FDA withdrawal of transvaginal mesh kits. Pelvic Organ Prolapse RCT (multicenter) · 2011
▸ Apical Suspension Repair At 36 months after vault-prolapse repair, sacrocolpopexy had lower composite treatment failure than native-tissue repair. Transvaginal mesh was noninferior to sacrocolpopexy but did not meet adjusted superiority over native tissue; mesh exposure was reported in 3–5%. Pelvic Organ Prolapse RCT (3-arm) · 2024
▸ CARE A concomitant Burch at sacrocolpopexy meaningfully lowers de novo stress incontinence in continent women. Pelvic Organ Prolapse RCT · 2006
▸ IMPROVE Debunks routine perioperative vaginal estrogen as a way to strengthen a native-tissue prolapse repair — use it for atrophy symptoms, not to protect the repair. Pelvic Organ Prolapse RCT (double-blind, placebo-controlled) · 2023
▸ OPTIMAL At 2 and 5 years, OPTIMAL did not demonstrate superiority of SSLF or ULS for composite outcomes and did not establish equivalence; choose based on anatomy, surgeon experience, and complications. Added perioperative behavioral therapy/PFMT did not show a significant benefit on measured outcomes. Pelvic Organ Prolapse RCT (2×2 factorial) · 2014
▸ PESSRI The reference randomized data on pessary selection: ring and Gellhorn perform similarly, so fit by anatomy and patient comfort rather than presumed efficacy. Pelvic Organ Prolapse RCT (crossover) · 2007
▸ PROSPECT Augmenting a primary vaginal prolapse repair with mesh or graft adds risk without benefit — key evidence behind the retreat from transvaginal mesh. Pelvic Organ Prolapse Pragmatic RCT · 2017
▸ SAM For uterine descent, the older Manchester procedure is at least as good as — and on key endpoints better than — sacrospinous hysteropexy, reviving interest in it. Pelvic Organ Prolapse RCT (noninferiority) · 2023
▸ SAVE-U Uterus preservation by sacrospinous hysteropexy is a legitimate alternative to vaginal hysterectomy for uterine prolapse — comparable durability, quicker recovery. Pelvic Organ Prolapse RCT (noninferiority) · 2015
▸ SUPeR Uterus-sparing mesh hysteropexy outperformed hysterectomy + USLS for durability — but the specific transvaginal mesh kit was withdrawn from the US market in 2019. Pelvic Organ Prolapse RCT · 2019
▸ BMG Harvest Closure Meta-analysis Leaving the buccal harvest site open is at least as good as closing it — slightly better early pain and long-term mouth opening. Settles a recurring intraoperative question with pooled randomized data. Urethral Stricture Systematic review & meta-analysis (of RCTs) · 2022
▸ OPEN For recurrent bulbar stricture, urethroplasty does not beat urethrotomy on early symptoms but markedly reduces the need for repeat procedures — favoring definitive repair. Urethral Stricture RCT · 2020
▸ ROBUST For selected men with recurrent short anterior strictures, Optilume offers a minimally invasive option between repeat endoscopy and urethroplasty. ROBUST III showed better 6-month anatomic success and 1-year freedom from repeat intervention than standard endoscopic management; urethroplasty was not compared, and longer follow-up lacks a contemporaneous control. Urethral Stricture RCT (ROBUST III) + single-arm follow-up · 2023
▸ Scandinavian Urethroplasty The first RCT in this space: BMG (non-transecting) is a less morbid alternative to EPA for short bulbar strictures, challenging EPA as the automatic choice. Urethral Stricture RCT · 2022
▸ USC-STAR Settled the reflux debate in neobladder design: a simple refluxing afferent limb is sufficient — the elaborate antireflux T-pouch adds morbidity without renal benefit. Why the Studer-type configuration predominates. Urinary Diversion RCT · 2015
▸ AUSCO Moves the AUS evidence base beyond single-center series — prospective, multicenter outcomes that benchmark continence and complications for counseling. Male SUI / Prosthetics Prospective single-arm multicenter study (industry-sponsored) · 2026
▸ InhibiZone In a retrospective manufacturer registry, antibiotic-impregnated implants were associated with fewer initial revisions due to infection than uncoated implants (1.1% of 35,737 vs 2.5% of 3,268 through 7.7 years). This is a revision endpoint, not an all-infection rate. Male SUI / Prosthetics Large comparative registry / cohort · 2011
▸ MASTER The first RCT comparing the male sling to the AUS for post-prostatectomy SUI: the sling is noninferior on the primary continence endpoint, but the AUS edges it on secondary outcomes — supporting the AUS as the benchmark for more severe incontinence. Male SUI / Prosthetics Noninferiority RCT · 2021
▸ IMPRESS I & II The trials behind the only FDA-approved drug (Xiaflex/CCH) for Peyronie's disease — established nonsurgical curvature correction as a real option for the stable-phase patient. Sexual Medicine RCT (two phase-3 trials) · 2013
▸ RestoreX RCT The first solid randomized evidence for penile traction therapy in Peyronie's — a low-risk mechanical adjunct that meaningfully reduces curvature, used alone or alongside intralesional therapy. Sexual Medicine RCT (single-blind) · 2019
▸ Sildenafil Pivotal Trial The trial that launched oral PDE5-inhibitor therapy and reframed ED as a treatable medical condition — the single most practice-changing study in sexual medicine, and the baseline against which every later ED therapy is judged. Sexual Medicine RCT (two studies) · 1998
▸ CombAT Confirms that a 5-ARI (alone or with an alpha-blocker) is what slows progression in larger prostates — the alpha-blocker drives early symptom relief, the 5-ARI prevents retention and surgery. Pairs with MTOPS as the basis for combination therapy. BPH / Male LUTS RCT · 2010
▸ COURAGE Supports adding a β3-agonist (vibegron) for storage/OAB symptoms that persist despite BPH outlet therapy — directly addresses the common "treated the prostate, still has urgency" scenario. BPH / Male LUTS RCT (double-blind, placebo-controlled) · 2024
▸ L.I.F.T. Established the prostatic urethral lift as a minimally invasive, ejaculation-preserving option for men who want to avoid TURP-type resection — at the cost of more modest flow gains. BPH / Male LUTS RCT (blinded, sham-controlled) · 2013
▸ MTOPS Foundational BPH medical-therapy trial: an alpha-blocker plus a 5-ARI together best slow disease progression in men with larger prostates — the basis for combination therapy. BPH / Male LUTS RCT · 2003
▸ PINNACLE Brings the drug-coated-balloon concept from urethral stricture (ROBUST) to BPH. FDA approved it on the totality of evidence, but the pivotal sham-controlled trial missed its prespecified primary endpoint; counsel on that basis. BPH / Male LUTS RCT (double-blind, sham-controlled) · 2023
▸ Rezūm (WAVE) Office-based water-vapor therapy gives durable symptom relief while preserving ejaculation — a minimally invasive middle ground between medication and TURP. BPH / Male LUTS RCT (sham-controlled) · 2016
▸ WATER First RCT for waterjet prostate ablation: equivalent symptom relief to TURP with less sexual dysfunction — the basis for Aquablation's role in BPH surgery. BPH / Male LUTS RCT (double-blind) · 2018
▸ ALTAR Gives a genuine non-antibiotic prophylaxis option for recurrent UTI — methenamine hippurate is a reasonable, stewardship-friendly alternative to daily antibiotics for the right patient. Infection / Prophylaxis RCT (open-label, noninferiority) · 2022
▸ ChEETAh This cluster-randomized trial found fewer 30-day surgical-site infections when teams changed gloves and instruments before closure of clean-contaminated, contaminated or dirty abdominal operations. Surgical / Perioperative Pragmatic cluster RCT · 2022
▸ Darouiche (CHG vs Povidone) The trial that made chlorhexidine–alcohol the default patient skin prep over povidone–iodine for most surgery — a core SSI-prevention step for every reconstructive case. Surgical / Perioperative RCT · 2010
▸ STITCH Established the small-bites, 4:1 suture-length-to-wound-length technique as the standard for midline fascial closure — directly applicable to every open abdominal reconstructive case. Surgical / Perioperative RCT (double-blind) · 2015
▸ WHO Surgical Safety Checklist In this eight-hospital before/after study of noncardiac surgery in patients aged at least 16, checklist implementation was associated with lower inpatient death (1.5% to 0.8%) and complications (11% to 7%) within 30 days. Surgical / Perioperative Prospective before-after study (8 hospitals) · 2009