Important Urology Studies

Benign Prostatic Hyperplasia
Study Comparison Findings
COMBAT (Roehrborn 2008, 2yr results) Tamsulosin vs dutasteride vs both vs placebo Combination therapy has greater benefit than either therapy alone for BPH symptoms
GOLIATH (Thomas 2016) TURP vs KTP for BPH Similar efficacy at 2yr between both therapies
HYCAT (Roehrborn 1997) Assess effect of a-blockers on PSA PSA unaffected by terazosin
LIFT (Roehrborn 2013) Prostates 30-80g randomized to UroLift or sham UroLift improves urinary function compared with baseline and sham, no reported ejaculatory or erectile side effects
MTOPS (McConnell 2003) Doxazosin vs finasteride vs both vs placebo Combination therapy has greater benefit than either therapy alone for BPH symptoms
PLESS (Roehrborn 1999) Effect of PSA and prostate volume on developing retention and need for BPH surgery PSA and prostate volume are predictors of developing retention and need for BPH surgery, finasteride lowers these risks
Bladder Cancer
Study Comparison Findings
Grossman 2003 NAC (MVAC x3) + cystectomy vs cystectomy only NAC provided increased overall survival (57% vs 43%) and increased pT0 at cystectomy (38% vs 15%)
JAVELIN (Powles 2020) Avelumab vs placebo after 1st line therapy for metastatic disease Increased median overall survival (21mo vs 14mo)
KEYNOTE-057 (Balar 2021) Pembrolizumab for T1 NMIBC Initial response 41%, durable response 21%
RAZOR (Parekh 2018) Open vs robotic cystectomy Robotic cystectomy noninferior
Svatek 2005 Cytology and cystoscopy as predictors of biopsy findings If concerning lesion, almost always cancer (82%)
If equivocal, no hx cancer, and negative cytology, 100% NPV for cancer
If equivocal, no hx cancer, and positive cytology, 100% sensitive for cancer
Kidney Cancer
Study Comparison Findings
ARISER (Chamie 2017) Girentuximab (antibody against G250) vs placebo in post-nephrectomy high risk RCC No difference in disease free or overall survival
ASSURE (Haas 2016) Sunitinib vs sorafenib vs placebo in post-nephrectomy high risk RCC No difference in disease free or overall survival at 6yrs
ATLAS (Gross-Goupil 2018) Axitinib vs placebo in pT3+ (post-nephrectomy) ccRCC No difference in disease specific or overall survival
CARMENA (Mejean 2018) Cytoreductive nephrectomy then sunitinib vs sunitinib only Sunitinib alone is noninferior, CRN should not be used alone
COMPARZ (Motzer 2013) Pazopanib vs sunitinib for metastatic RCC Similar efficacy, safety and QoL favor pazopanib
EVEREST (Ryan 2022) Everolimus vs placebo in pT2+ (post-nephrectomy) ccRCC Non-significant improvement in recurrence free survival with everolimus
METEOR (Choueiri 2015) Cabozantinib vs everolimus after metastatic progression after first-line therapy Cabozantinib has increased disease-free and overall survival
PISCES (Escudier 2014) Pazopanib vs sunitinib for metastatic RCC Patients prefer pazopanib (70% vs 22%)
PROTECT (Motzer 2017) Pazopanib vs placebo in pT2+ (post-nephrectomy) RCC No difference in disease free or overall survival
SORCE (Eisen 2020) sorafenib vs placebo in intermediate/high risk RCC No difference in disease-free or overall survival
S-TRAC (Ravaud 2016) Sunitinib vs placebo for locoregional ccRCC 6.8 vs 5.6 yr disease free survival, no difference in overall survival
SURTIME (Bex 2019) Cytoreductive nephrectomy then sunitinib vs sunitinib then cytoreductive nephrectomy then sunitinib No clear improvement in survival with delayed CRN
Overactive Bladder
Study Comparison Findings
ARTISAN-SNM (Pezzella 2020) Assess feasibility of rechargable SNM device Rechargeable device is safe/efficacious
INSITE (Noblett 2018) Assess efficacy of interstim (SNM) for less severe and more severe patients SNM is efficacious for patients of all symptom severities
ROSETTA (Amundsen 2018) 200U botox vs sacral neuromodulation for refractory urge incontinence Similar treatment efficacy at 2yr, botox provided higher satisfaction but higher risk of UTI
SUMIT (Peters 2010) PTNS vs sham for OAB PTNS has significant benefit over sham (55% improvement vs 21%)
SYNERGY (Mueller 2018) Solifenacin vs mirabegron vs combination Combination therapy provides greatest benefit with minimal increase in side effects
Pediatrics
Study Comparison Findings
KIMONO (Westland 2013) Identify risk factors for renal injury in solitary kidney patients 1/3 develop renal injury by 10yo, risk increased if congenital anomaly present in solitary kidney
MOMS (Adzick 2011) Prenatal intrautero vs postnatal repair of myelomeningocele Prenatal repair reduces need for VP shunt and improves motor function, but carries maternal and fetal risks
PLUTO (Morris 2013) Vesicoamniotic shunt vs conservative management of in-utero lower urinary tract obstruction in male fetuses No significant improvement with shunting, shunt placement does have complication risks, only 31 patients included
RIVUR (NEJM 2014) Antibiotics vs placebo for prevention of subsequent febrile UTI Prophylaxis reduced risk of recurrence especially if baseline voiding dysfunction, but did not alter risk of renal scarring
Pelvic Organ Prolapse
Study Comparison Findings
OPTIMAL
(Barber 2014)
Uterosacral ligament suspension vs sacrospinous ligament fixation No difference in outcomes
Peyronie Disease
Study Comparison Findings
IMPRESS
(Gelbard 2013)
Intralesional collagenase vs placebo 34% average improvement
Localized Prostate Cancer
Study Comparison Findings
ERSPC (Schroder 2009) Regular PSA screens vs no screens 20% reduction in cancer-specific mortality with screening at 16yrs, requires screening 570 men to prevent 1 death
MRI-First (Rouvière 2019) Systematic + targeted biopsy vs targeted biopsy only after prostate MRI Best diagnosis obtained with combination of systematic + targeted biopsy, obtaining MRI prior to biopsy does not prevent need for systematic biopsy
PCPT (Thompson 2003) Effect of finasteride on preventing prostate cancer 25% reduction in cancer diagnoses but increased diagnosis high grade cancer (gland shrinkage may increase detection of clinically significant cancers), overall does not seem to affect mortality
PIVOT (Wilt 2012) watchful waiting vs radical prostatectomy No change in overall or cancer-specific mortality, but prostatectomy decreased progression risk (41% vs 68%) and decreased treatment for progression (34% vs 60%)
PLCO (Andriole 2012) Regular PSA screens vs no screens No reduction in cancer-specific mortality at 17yrs, but a lot of crossover contamination with PSA screening in the "unscreened" cohort
Pound 1999 Observation of biochemical recurrence after prostatectomy Recurrence does not happen without a rising PSA, 8-10yr median time from PSA rise to metastasis, GG1-3 develop metastases within 10yrs, GG4-5 develop metastases within 5yrs, 5yrs to develop metastases if PSA starts rising within 2yrs otherwise develop metastases within 10-15yrs, developmetastases within 5yrs if PSAdt < 10mo, development of metastases leads to death at median 5yrs
PRECISION (Kasivisvanathan 2018) mpMRI + targeted biopsy vs standard biopsy alone mpMRI more likely to detect cancer (38% vs 26%) and less likely to diagnose clinically insignificant cancer
PROMIS (Ahmed 2017) mpMRI + template biopsy + saturation biopsy mpMRI is more sensitive (93%) but less specific (41%) for clinically significant cancer compared to template biopsy, would help 27% avoid a biopsy, would help detect 18% more clinically significant cancer
ProtecT (Hamdy 2016) observation vs prostatectomy vs XRT No difference in cancer-specific mortality at 10yrs, but observation had increased disease progression (23% vs 5%) and more likely to start ADT (8% vs 5%)
REDUCE (Andriole 2010) Effect of dutasteride on preventing prostate cancer 23% reduction in cancer diagnoses but increased diagnosis high grade cancer
SELECT (Klein 2011) Effect of selenium and/or Vitamin E on preventing prostate cancer No benefit, Vitamin E appears to slightly increase cancer risk (17% from controls)
SPCG-4 (Bill-Axelson 2011) watchful waiting vs radical prostatectomy Prostatectomy increased overall survival by 12%, 2.9yr median increase at 23yrs follow-up
TACT (Klotz 2020) Assess safety/efficacy of transurethral US ablation of prostate cancer (TULSA) Device is safe/efficacious, with 79% negative biopsy at 12mo, 75% retained erectile function
Post-Prostatectomy XRT
Study Comparison Findings
Bastide Adding ADT increased BCR-free rates with aXRT (83% vs 44% at 5yrs, 62% vs 29% at 7yrs)
EORTC 22911 (Bolla 2012) aXRT vs "wait and see" approach after radical prostatectomy aXRT decreased locoregional recurrence (8% vs 17%), no difference in overall survival (26% vs 23%), decreased overall survival if negative surgical margins on specimen (HR 1.68)
GETUG-AFU17 (Sargos 2020) aXRT vs sXRT after radical prostatectomy Not statistically significant, but aXRT did not show event-free survival benefit and increased GU toxicity
RADICALS-RT (Parker 2020) aXRT vs sXRT after radical prostatectomy No difference in biochemical progression or need for hormonal therapy, aXRT more likely to cause side effects
RAVES (Kneebone 2020) aXRT vs sXRT after radical prostatectomy Non-inferiority not proven, but data seems to show similar efficacy, sXRT decreases overtreatment and has less GU toxicity
RTOG 96-01 (Shipley 2017) sXRT + ADT vs sXRT alone after radical prostatectomy salvage XRT + ADT showed increased survival benefit and decreased death from prostate cancer at 12yrs
SWOG 8794 (Thompson 2006) aXRT vs "wait and see" approach after radical prostatectomy At 10yrs, aXRT decreased locoregional recurrence (8% vs 22%), increased hormone-free survival(84% vs 66%), increased overall survival (74% vs 66%), NNT 9.1 for overall survival and 12.2 for metastatic disease
Metastatic Prostate Cancer
Study Comparison Findings
AFFIRM (Scher 2012) mCRPC post-docetaxel, enzalutamide vs placebo Improved progression-free and overall survival
ALSYMPCA (Parker 2013) mCRPC + symptomatic bone mets, Rad 223 vs placebo Improved overall survival
ARAMIS (Fizazi 2019) non-mCRPC, darolutamide vs placebo Improved progression-free survival
ARCHES (Armstrong 2019) mHSPC, ADT + enzalutamide vs ADT Improved progression-free and overall survival
CARD (de Wit 2019) mCRPC w/ two prior therapies, cabazitaxel vs ART therapy Improved overall survival
CHAARTED (Sweeney 2015) mCRPC, ADT + docetaxel vs ADT Improved overall survival
COU-AA-301 (de Bono 2011) mCRPC post-docetaxel, abiraterone vs placebo Improved progression-free and overall survival
COU-AA-302 (Ryan 2013) mCRPC, chemo-naive, abiraterone vs placebo Improved progression-free and overall survival
ENZAMET (Davis 2019) mCSPC, enzalutamide vs bicalutamide Improved progression-free and overall survival
FIRSTANA (Oudard 2017) mCRPC, docetaxel vs cabazitaxel No difference overall survival
GETUG-AFU15 (Gravis 2013) mCRPC, ADT + docetaxel vs ADT + placebo Overall survival not superior
HORRAD (Boeve 2019) mCSPC, ADT vs EBRT + ADT Improved PSA progression but no difference in overall survival
IMPACT (Kantoff 2010) asymptomatic/minimally symptomatic mCRPC, Sipuleucel-T vs placebo Improved overall survival
LATITUDE (Fizazi 2017) mCSPC, abiraterone vs placebo Improved progression-free and overall survival
NCIC PR.7 (Crook 2012) post-XRT BCR, non-mCRPC, intermittent vs continuous ADT Intermittent ADT is non-inferior for overall survival
PREVAIL (Beer and Tombal 2014) mCRPC, chemo-naive, enzalutamide vs placebo Improved progression-free and overall survival
PROFOUND (Hussain 2020) mCRPC with progression on enzalutamide/abiraterone, Olaparib vs enzalutamide/abiraterone Improved progression free and overall survival
PROSPER (Sternberg 2020) non-mCRPC, enzalutamide vs placebo Improved progression-free and overall survival
SPARTAN (Smith 2018) non-mCRPC, apalutamide vs placebo Improved progression-free survival
STAMPEDE (James 2017) mostly mCRPC, ADT + docetaxel/abiraterone vs ADT Docetaxel and abiraterone improved overall survival, ADT + XRT potential treatment for low-volume mCSPC
STRIVE (Penson 2016) non-mCRPC, enzalutamide vs bicalutamide Improved progression-free survival
SWOG-9346 (Hussain 2013) mCRPC, intermittent vs continuous ADT Did not confirm non-inferiority of iADT for overall survival
TAX 327 (Tannock 2004) mCRPC, docetaxel + prednisone vs mitoxantrone + prednisone Improved overall survival if dosed q3wk but not qweek
TERRAIN (Shore 2016) non-mCRPC, enzalutamide vs bicalutamide Improved progression-free survival
TITAN (Chi 2019) mCSPC, ADT + apalutamide vs ADT Improved progression-free and overall survival
TROPIC (de Bono 2010) mCRPC post-docetaxel therapy, Cabazitaxel vs Mitoxantrone Improved overall survival
Sexual Dysfunction
Study Comparison Findings
RECONNECT (Kingsberg 2019) Bremelanotide vs placebo for female sexual interest disorder Improves desire and decreases distress
Stones
Study Comparison Findings
Borghi 1996 Increased (> 2L) vs normal fluid intake Decreased stone rates over 5yrs compared to controls (27% vs 12%)
Borghi 2002 Low calcium diet versus low protein + low salt + moderate calcium Moderate calcium diet had a 50% reduction in stone events compared to low calcium diet
Lotan 2004 Cost efficiency of metabolic stone workup 1st time stone formers are most cost effectively managed w/ conservative therapy, but metabolic workup is more beneficial for recurrent stone formers
Stress Urinary Incontinence
Study Comparison Findings
CARE
(Visco 2008)
Effect of colposuspension at time of sacrocolpopexy (for POP) in patients without preoperative SUI Colposuspension leads to less postoperative SUI
OPUS
(Wei 2009)
Effect of retropubic midurethral sling placement at time of anterior vaginal wall prolapse repair RP-MUS placement decreases SUI rates (27% vs 43%), NNT 6.3
SISTEr
(Albo 2007)
Pubovaginal sling vs Burch colposuspension PVS has greater negative postop stress test (66% vs 49%), cure rate (47% vs 38%), less retreatment (4% vs 13%), but more likely to cause voiding dysfunction and cystitis
TOMUS
(Kobashi 2017)
Retropubic vs transobturator midurethral slings Overall no difference in treatment success rates at 5yrs
VALUE
(Nager 2012)
Benefit of UDS before sling placement No proven benefit to performing empiric UDS if clear SUI on exam
Testis Cancer
Study Comparison Findings
SWENOTECA (Tanstad 2011) Comparison of management strategies for Stage I NSGCT Relapse rates 12% surveillance, 1% BEP x1, 0% BEP x2, no difference in deaths
Upper Tract Urothelial Cancer
Study Comparison Findings
ODMIT-C (O'Brien 2011) Postoperative intravesical mitomycin vs standard foley care after nephroureterectomy Decreased risk of bladder tumors (AR=11%, RR=40%, NNT=9)
OLYMPUS (Kleinmann 2020) Mitomycin hydrogel administration for existing UTUC Complete response 59%, subset (70%) had sustained response at 1yr, 40% had side effects
POUT (Birtle 2018) pT2-4 N0-3, adjuvant chemotherapy (gem/cis) vs surveillance Survival 70% vs 51% (HR=0.49)

References