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 de novo stress incontinence 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 Both sling routes work about equally well; 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 first FDA-cleared 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 PTNS is at least as effective as an antimuscarinic for OAB — useful when patients want to avoid drug side effects. 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 Level-1 evidence that PTNS beats sham for OAB — established neuromodulation by the tibial route as a real, drug-free third-line option. OAB / Urgency Incontinence RCT (double-blind, sham-controlled) · 2010
▸ CAPABLe First-line fecal-incontinence therapies (loperamide, biofeedback) help, but this rigorous trial found no clear winner — tempers expectations and supports a pragmatic, patient-preference approach before escalating. 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 For vault prolapse, mesh-augmented repair (sacrocolpopexy or transvaginal mesh) is more durable than native-tissue repair — a counterpoint to the broader anti-mesh trend, in expert hands. 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 SSLF and ULS are equivalent for apical prolapse — pick by surgeon comfort and anatomy — and adding perioperative PFMT does not help. 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 A new minimally invasive middle ground between endoscopic treatment and urethroplasty for recurrent short strictures — better durability than repeat DVIU/dilation. 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
▸ AUS-COT Moves the AUS evidence base beyond single-center series — prospective, multicenter outcomes that benchmark continence and complications for counseling. Male SUI / Prosthetics Prospective multicenter cohort · 2025
▸ InhibiZone Established antibiotic surface-coating as standard for inflatable penile prostheses — one of the key advances that pushed implant infection rates to ~1%. 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 (already validated for urethral stricture in ROBUST) to BPH — a quick, ejaculation-sparing option with strong 12-month symptom and flow gains. 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 A near-free, low-tech step — fresh gloves and clean instruments before fascial closure — measurably lowers SSI; trivially adoptable in any reconstructive case. 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 The study that made the surgical safety checklist (sign-in / time-out / sign-out) a global standard — a near-free intervention that measurably cuts perioperative death and complications in every kind of surgery. Surgical / Perioperative Prospective before-after study (8 hospitals) · 2009