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Intraoperative Visualization Agents

Visualization agents (fluorescent dyes, visible dyes, and photosensitizers) enable intraoperative tissue identification, perfusion assessment, lymphatic mapping, tumor detection, and fistula / leak localization in urology and urogynecology. Indocyanine green (ICG) is the dominant agent and has transformed robotic urologic surgery through integration with near-infrared (NIR) fluorescence platforms (Firefly, SPY, PINPOINT, Rubina).[1][2] This article is the clinical-application hub: procedures and evidence by indication. For agent-level pharmacology, dosing, and imaging-hardware compatibility, see the dedicated pharmacology pages:

For imaging hardware, see Robotics platforms.

Agent quick-reference​

AgentClassDetectionExcretionPrimary urologic role
ICGTricarbocyanine NIR fluorophoreNIR camera (Firefly / SPY)HepaticPerfusion, renal-mass localization, SLN mapping, and retrograde ureteral localization[1][3]
Methylene bluePhenothiazine visible dyeWhite light ± NIRRenalUreteral ID, fistula localization[4]
Indigo carmineVisible dyeWhite lightRenalCystoscopic ureteral-efflux aid; BLUDIGO approved in 2022[38]
Sodium fluoresceinVisible / UV dyeWhite light / cobalt-blueRenal (rapid)Ureteral jet visualization post-indigo-carmine era[6][7]
Pudexacianinium (ASP-5354)Renally-excreted ICG derivative, NIRNIR cameraRenalInvestigational IV ureteral visualization[8][9]
Hexaminolevulinate (Cysview)PDD photosensitizerBlue-light cystoscopeN/ABladder-cancer detection[10][11]
5-ALAPDD photosensitizerBlue-light cystoscopeN/ABladder-cancer detection (oral or intravesical)[12]
Oral phenazopyridineAzo dye (non-fluorescent)White-light cystoscopeRenalOff-label ureteral jet aid; favorable in a historical cost model[13]
Rizedisben (Illuminare-1)Myelin-binding fluorophoreBlue-light camera—Investigational nerve-specific imaging[14]

Robot-assisted partial nephrectomy (RAPN) — ICG's flagship urologic application​

Meta-analytic evidence​

Giulioni 2023 meta-analysis (8 comparative studies, n = 535; predominantly observational evidence):[15]

  • ICG-guided RAPN: lower warm ischemia time (WMD −2.05 min; p = 0.011)
  • Postoperative eGFR: Giulioni 2023 found a 7.67 mL/min higher postoperative eGFR in five comparative studies (123 ICG vs 234 controls; p = 0.002).[15] An updated 2025 synthesis included 11 controlled RAPN studies (893 patients, including two RCTs), but its endpoint-specific eGFR analyses included 136–261 patients and found no statistically significant difference at discharge or at 1, 3, or 6 months.[42]
  • No statistically demonstrated difference in positive surgical margin rates or tumor recurrence

Diana 2020 TRoNeS multi-institutional series (n = 318): trifecta 79.9% and MIC 71.7%. There was no control group. Imaging may aid strategy in difficult vascular anatomy.[3]

Three distinct intraoperative functions​

FunctionTechniqueEvidence
Renal-mass localizationSolid masses may be hypofluorescent against normal parenchyma whether benign or malignantTobis 2011 — 7/10 malignant tumors hypofluorescent, 3 isofluorescent[16][17]; Manny 2013 — 18/83 hypofluorescent solid masses benign, with 57% specificity for malignancy[46]
Selective arterial clampingICG injection after selective clamp confirms ischemic zone; enables superselective ischemia preserving uninvolved parenchymaHarke 2014 matched-pair (15 per arm) — short-term eGFR loss 5.1 vs 16.1 mL/min selective vs global (p = 0.045)[18]
Endophytic tumor markingPreoperative superselective transarterial ICG-lipiodol embolization tags totally endophytic masses for intraoperative NIRF identificationSimone 2019 described the approach[19]; Nardis 2022 (41 patients) — 26/41 had well-defined margins, 14/41 had blurred margins, and 1/41 was not visible; embolization technical success was 41/41[20]

Sentinel lymph node (SLN) mapping​

Penile cancer — strongest SLN evidence​

EAU/ASCO guidance, current 2026 chapter, recommends surgical staging for high-risk cN0 disease (T1b or higher), preferably DSNB at an experienced center (Strong recommendations for staging and DSNB).[21] ICG is an adjunct in hybrid-tracer workflows.[21]

  • Dell'Oglio 2020 (n = 400 patients / 740 groins): hybrid ICG-⁹⁹ᵐTc-nanocolloid localized all pre-op-defined SNs; fluorescence detected 96% of all excised SNs and yielded a 39% higher detection rate than blue dye among the 266 patients (492 groins) given both tracers (p < 0.001)[22]
  • Zhang 2023 meta-analysis of ICG-NIR for SLN metastasis in penile cancer: 100% pooled sensitivity; specificity 2%.[23]

Prostate cancer​

  • Manny 2014 (n = 50): percutaneous robotic-guided ICG injection identified SLNs in 76% with 100% sensitivity and NPV for nodal metastasis[24]
  • Li 2026 (n = 34): cystoscopic ICG injection, fluorescence detection 97.1%, 100% per-patient sensitivity and NPV, but per-node sensitivity only 66.7%. No metastatic nodes occurred in the low/intermediate-risk subgroup. All participants also underwent extended pelvic lymph-node dissection[25]
  • Wu 2019 meta-analysis (17 studies, n = 1,059 pelvic malignancies): pooled detection rate 95% (95% CI 93–97); pooled sensitivity 86% (75–94); no ICG-related complications reported.[26]

Radical prostatectomy — tissue marking​

ICG injected into the prostate provides tissue marking that differentiates prostate from surrounding structures (NVB, seminal vesicles, vas deferens, obturator nerve) at mean 10 min post-injection.[24]

Ureteral identification and patency​

The 2014 indigo-carmine shortage prompted studies of alternatives. BLUDIGO now has a US label for adult cystoscopic ureteral assessment, so permanent-unavailability language is obsolete.[38] Dye efflux establishes urine passage at that time; it does not exclude all partial or delayed thermal/ischemic injuries. The 2018 AUGS consensus calls for cystoscopy during pelvic organ prolapse reconstruction, except operations solely for posterior-compartment defects; select the efflux aid according to patient factors and availability.[5]

Imaging approaches during robotic or laparoscopic pelvic surgery​

AgentTechniqueDetectionTime to jetCost
Sodium fluoresceinOff-label; 0.25–1.0 mL of 10% solution IV (25–100 mg; Grimes used 25 mg)[6][30]White-light cystoscopeCatheter urine color change: mean 5.1 min, not cystoscopic jet timing[7]Moderate
Methylene blueOff-label protocols; see agent hub for systemic precautionsVisible light or a compatible fluorescence system, depending on methodVariable[4][28]Local acquisition cost
ICG (intraureteral, off-label)ICG is hepatically cleared[1]; retrograde catheter instillation has been described for luminal localization[47]. A 2026 systematic review associated stent/catheter fluorescence methods with a higher incidence of technique-related adverse events[48]Compatible NIR cameraReal-time after instillationLocal procedural cost
Pudexacianinium (investigational)IV, renally excretedNIRIndex-ureter fluorescence at 30 min and surgery end in 3/3 at 3 mg (12-patient Phase 2 study; not a jet endpoint)[9]Investigational

Oral agent​

Phenazopyridine 200 mg orally 1 hour before surgery.[7] Orange urine aids ureteral-jet visualization under white-light cystoscopy. A phenazopyridine-first strategy was least costly in the Askew 2022 decision model (mean total modeled cost $110/patient).[13] A 12-patient nonrandomized cohort found mean times to urine color change in an indwelling catheter of approximately 82 minutes for phenazopyridine versus approximately 5 minutes for fluorescein.[7] Check renal contraindications in the phenazopyridine hub.

Bladder-distension alternative​

Mannitol bladder distension. Grimes 2017 RCT reported the highest overall surgeon satisfaction for ureteral-patency assessment without an IV agent.[30] In a retrospective cohort of 925 women undergoing vaginal hysterectomy with high uterosacral suspension, postoperative ureteral injury occurred in 11/545 (2.0%) with saline versus 1/380 (0.3%) with mannitol bladder distension at discharge or 1-month follow-up.[49]

RCT guidance​

Espaillat-Rijo 2016 RCT (n = 176): sodium fluorescein and 10% dextrose significantly improved visibility and surgeon satisfaction versus saline.[31]

AUGS Consensus 2018. It acknowledges the indigo-carmine shortage, reviews sodium fluorescein and phenazopyridine as defensible alternatives, and supports cystoscopic assessment at pelvic reconstructive surgery.[5]

Methylene-blue ureteral identification during open / MIS surgery​

de'Angelis 2023 WSES IUTI guideline summarizes four studies in which 91 of 102 ureters (89.2%) were identified by fluorescence after IV methylene blue (0.25–1.0 mg/kg, starting as early as 40 min before surgery).[4] Advantages: IV administration, no cystoscopy or stenting required. This is a fluorescence-imaging use that needs a compatible NIR system, and it is off-label. WSES lists G6PD deficiency, renal impairment and Heinz-body hemolytic anemia as contraindications to off-label IV methylene-blue fluorescence; the US PROVAYBLUE label contraindicates G6PD deficiency and prior severe hypersensitivity to methylene blue or another thiazine dye, with a modified methemoglobinemia regimen for moderate or severe renal impairment.[4][39] Separately, the US methylene-blue label carries a boxed warning for serotonin syndrome with serotonergic drugs and opioids (SSRIs, SNRIs, MAO inhibitors), so review the medication list with anesthesia before any IV dose.[39]

Pudexacianinium — investigational ureteral imaging​

In Wistar rats and Göttingen minipigs, IV pudexacianinium, an ICG derivative excited at 780 nm and emitting at 820 nm, produced ureteral fluorescence; minipig abdominal videos were acquired with a pde-neo NIR camera.[8] Albert 2023 Phase 2 RCT (n = 12 colorectal) showed dose-dependent success: 2/3 at 0.3 mg, 5/6 at 1.0 mg, 3/3 at 3.0 mg; one grade 1 proteinuria AE.[9] The current agent hub records phase III development and 2026 renal pharmacokinetic evidence. No US approval was identified; injury reduction and universal camera compatibility are not established. Molecular imaging reviews describe the broader tracer-development context.[29]

Fistula localization​

Intravesical methylene blue can show vaginal leakage from a bladder or urethral fistula; clear vaginal leakage with a negative bladder dye test raises suspicion for a ureterovaginal fistula.[41] The three-swab (or double-dye) test is a classic clinical-exam adjunct combining intravesical methylene blue with oral phenazopyridine to distinguish VVF from UVF. Detailed in the clinical Vesicovaginal fistula literature.

ICG has been used in select fistula cases where NIR platforms are available, particularly for vesicouterine or uterocutaneous fistula mapping during robotic repair.

Bladder cancer detection — photodynamic diagnosis (PDD)​

Hexaminolevulinate (Cysview) and 5-aminolevulinic acid (5-ALA) are photosensitizing prodrugs rather than visualization dyes in the traditional sense, enabling blue-light cystoscopy (BLC) for enhanced bladder-cancer detection.

Mechanism​

After intravesical instillation (hexaminolevulinate) or oral administration (5-ALA), the prodrug enters mucosal cells and is converted to protoporphyrin IX (PpIX), which accumulates preferentially in neoplastic cells due to altered enzymatic activity. Under blue light (360–450 nm), tumor tissue fluoresces bright red against a dark blue normal urothelial background.[10][11]

Hexaminolevulinate (Cysview) — FDA-approved​

  • June 2026 CYSVIEW label: Reconstitute 100 mg in the supplied diluent to 50 mL and retain intravesically for 1–3 hours; begin cystoscopy within 30 minutes after evacuation and no later than 3 hours after instillation. Examine the entire bladder under white light, then under blue light if there is no widespread mucosal inflammation; map lesions before biopsy or resection. Use an authorized blue-light system. Gross hematuria is no longer a contraindication, although blood can interfere with visualization.[10]
  • Kamat 2016 reviews bladder-cancer diagnosis and treatment, including the role of enhanced visualization[32]
  • Maisch 2026 Cochrane update (17 RCTs, 4,890 participants; search through March 2026): blue-light TURBT may reduce recurrence and progression depending on baseline risk; absolute benefit is greater at higher risk. Most evidence remains low certainty, and a mortality benefit is not established[33]

5-ALA​

  • Inoue 2012. 5-ALA fluorescence cystoscopy detected 72.1% of flat lesions (dysplasia / CIS) missed by conventional endoscopy; no statistically significant route difference in this retrospective study[12]
  • Ishikawa 2026 region-specific analysis: oral 5-ALA performance varies by bladder region[34]

Guideline position​

AUA/SUO 2026 advises upper-tract evaluation, random bladder biopsies and prostatic-urethral biopsies in patients with a history of NMIBC, normal cystoscopy and cytology positive for high-grade urothelial carcinoma; BLC is used when available . It recommends offering BLC at TURBT when available to improve detection and reduce recurrence .[40]

EAU 2026 recommends mapping biopsies or PDD-guided biopsies for positive cytology with normal-looking bladder mucosa and normal upper-tract imaging . Also exclude an upper-tract tumor and, when relevant, prostatic urethral disease.[35]

Limitations​

False-positive fluorescence can occur with inflammation, recent TURBT, or recent intravesical BCG or chemotherapy.[33][40] Tissue-penetration depth is limited.[33]

Emerging applications​

Rizedisben (Illuminare-1) — nerve-specific imaging​

Novel small-molecule fluorophore that binds myelin and fluoresces at 370–425 nm to enhance nerve visualization. Gold 2025 single-arm phase I study enrolled 38 robotic radical prostatectomy patients: at 3.0 mg/kg, sustained obturator-nerve fluorescence occurred in 9/9, while moderate-or-better periprostatic neurovascular-bundle contrast occurred in 3/9.[14] This phase I, 38-patient study establishes early feasibility.

Ureteral reconstruction and perfusion assessment​

ICG can supplement assessment of anastomotic perfusion during robotic ureteral reimplantation and reconstruction. Cacciamani 2020 expert consensus systematic review covers technique and safety in detail.[27] A 2026 meta-analysis of four observational robot-assisted radical cystectomy studies (886 patients; 1,739 ureters) estimated a per-ureter ureteroenteric stricture RR of 0.31 with ICG versus no ICG (95% CI 0.08–1.16; very-low-certainty evidence); evidence is insufficient to determine whether ICG prevents strictures.[45]

Pediatric urology​

ICG-NIRF has been applied in pediatric partial nephrectomy (duplex systems, tumors), lymphatic-sparing varicocele repair, and oncologic procedures.[36] Published pediatric series describe feasibility.[36]

Safety — the comparative profile​

AgentAdverse-event profileCritical contraindications
ICGAnaphylaxis, including fatal reactionsICG hypersensitivity; current label does not make shellfish or nonspecific iodine allergy a blanket contraindication[37]
Methylene blueHemolysis; boxed serotonin-syndrome warningG6PD deficiency and severe thiazine hypersensitivity; avoid serotonergic-drug/opioid interactions[39]
Indigo carmine / BLUDIGOSerious cardiovascular reactions, anaphylaxis and oximetry interferenceDrug/component hypersensitivity; not recommended eGFR <30 (a precaution, not the formal contraindication)[38]
Sodium fluoresceinTransient skin/scleral yellowing; anaphylactic shock has been reported after IV fluorescein for cystoscopic ureteral-efflux assessment, and incidence at GU doses is unknown[43]Known fluorescein or product-component hypersensitivity is a FLUORESCITE contraindication; its label advises having an emergency tray available[44]
PudexacianiniumRenal exposure rises in CKDInvestigational
CYSVIEWFalse fluorescence; hypersensitivityPorphyria; hypersensitivity to aminolevulinic acids or product components. Oral 5-ALA has separate jurisdiction/product precautions[10]

Evidence Summary​

ApplicationEvidence levelKey source
RAPN perfusion / ischemiaComparative-study meta-analysis; largely observationalGiulioni 2023[15]; Diana 2020 TRoNeS[3]
Selective clampingLevel 2 (matched-pair)Harke 2014[18]
Endophytic tumor taggingLevel 3Simone 2019[19]; Nardis 2022[20]
Penile-cancer SLNGuideline-supported DSNB; ICG adjunct studiesEAU/ASCO 2026[21]; Dell'Oglio 2020[22]; Zhang 2023[23]
Prostate-cancer SLNLevel 2–3Manny 2014[24]; Li 2026[25]; Wu 2019 meta[26]
Ureteral-patency post-indigo-carmineLevel 1 (multiple RCTs)Espaillat-Rijo 2016[31]; Grimes 2017[30]; Askew 2022 CEA[13]
Methylene-blue ureteral IDFour studies summarized in a WSES guideline (fluorescence detection)de'Angelis 2023[4]
PudexacianiniumSmall phase II dose-ranging studyAlbert 2023[9]; Fushiki 2023 preclinical[8]
Bladder-cancer BLCCochrane RCT synthesis; mostly low certaintyKamat 2016[32]; Maisch 2026 Cochrane[33]; EAU 2026[35]
Rizedisben nerve imagingLevel 3 (non-randomized trial)Gold 2025[14]

Clinical Positioning​

  • Perfusion: ICG can inform intraoperative assessment.[3][15][27]
  • Lymphatic mapping: use established tumor-specific staging pathways. ICG fluorescence is not a pathology result and does not justify omitting indicated nodal surgery.[21][22]
  • Ureteral assessment: BLUDIGO is currently labeled[38]; fluorescein, phenazopyridine and methylene-blue approaches require their own safety review.
  • New agents: pudexacianinium and rizedisben remain investigational; feasibility and good visualization are different from improved patient outcomes.[9][14]
  • Blue-light cystoscopy: use the current CYSVIEW label and bladder-cancer guidelines. The 2026 Cochrane update supports possible risk-dependent benefit with important uncertainty.[10][33][35]
  • Drug safety: ICG hypersensitivity, methylene-blue interactions/G6PD deficiency and BLUDIGO cardiovascular reactions require distinct checks. See the individual drug hubs for dosing and monitoring.[37][38][39]

See Also​

References​

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2. Fransvea P, Miccini M, Rondelli F, et al. "A green lantern for the surgeon: a review on the use of indocyanine green (ICG) in minimally invasive surgery." J Clin Med. 2024;13(16):4895. doi:10.3390/jcm13164895

3. Diana P, Buffi NM, Lughezzani G, et al. "The role of intraoperative indocyanine green in robot-assisted partial nephrectomy: results from a large, multi-institutional series." Eur Urol. 2020;78(5):743–749. doi:10.1016/j.eururo.2020.05.040

4. de'Angelis N, Schena CA, Marchegiani F, et al. "2023 WSES guidelines for the prevention, detection, and management of iatrogenic urinary tract injuries (IUTIs) during emergency digestive surgery." World J Emerg Surg. 2023;18(1):45. doi:10.1186/s13017-023-00513-8

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9. Albert M, Delgado-Herrera L, Paruch J, et al. "Pudexacianinium (ASP5354) chloride for ureter visualization in participants undergoing laparoscopic minimally invasive colorectal surgery." Surg Endosc. 2023;37(9):7336–7347. doi:10.1007/s00464-023-10193-9

10. CYSVIEW. US prescribing information, revised June 2026. DailyMed.

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19. Simone G, Tuderti G, Anceschi U, et al. "'Ride the green light': indocyanine green-marked off-clamp robotic partial nephrectomy for totally endophytic renal masses." Eur Urol. 2019;75(6):1008–1014. doi:10.1016/j.eururo.2018.09.015

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21. EAU/ASCO. Penile Cancer Guidelines, 2026: diagnostic evaluation and staging. Current chapter.

22. Dell'Oglio P, de Vries HM, Mazzone E, et al. "Hybrid indocyanine green–⁹⁹ᵐTc-nanocolloid for single-photon emission computed tomography and combined radio- and fluorescence-guided sentinel node biopsy in penile cancer: results of 740 inguinal basins assessed at a single institution." Eur Urol. 2020;78(6):865–872. doi:10.1016/j.eururo.2020.09.007

23. Zhang R, Zhang Y, Dong S, et al. "Performance of indocyanine green in sentinel lymph node mapping and lymph node metastasis in penile cancer: systematic review, meta-analysis, and single-center experience." World J Urol. 2023;41(9):2319–2326. doi:10.1007/s00345-023-04485-x

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25. Li YH, Chuang YF, Ou YC, et al. "Cystoscopic ICG-guided sentinel lymph node dissection in robotic radical prostatectomy: a prospective study." Prostate. 2026. doi:10.1002/pros.70107

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28. Cwalinski T, Polom W, Marano L, et al. "Methylene blue — current knowledge, fluorescent properties, and its future use." J Clin Med. 2020;9(11):E3538. doi:10.3390/jcm9113538

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31. Espaillat-Rijo L, Siff L, Alas AN, et al. "Intraoperative cystoscopic evaluation of ureteral patency: a randomized controlled trial." Obstet Gynecol. 2016;128(6):1378–1383. doi:10.1097/AOG.0000000000001750

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39. PROVAYBLUE. US prescribing information (current DailyMed version effective May 2025; boxed warning 11/2023). DailyMed.

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45. Nominato EO, Miranda AARR, Fernandes MEM, et al. "Intraoperative indocyanine green fluorescence guidance to reduce ureteroenteric anastomotic strictures during robot-assisted radical cystectomy. A systematic review and meta-analysis." Urol Oncol. Published online September 3, 2026. doi:10.1016/j.urolonc.2026.08.003

46. Manny TB, Krane LS, Hemal AK. "Indocyanine green cannot predict malignancy in partial nephrectomy: histopathologic correlation with fluorescence pattern in 100 patients." J Endourol. 2013;27(7):918–921. doi:10.1089/end.2012.0756

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49. Barba M, Cola A, Costa C, Frigerio M. "Impact of mannitol bladder distension in the intraoperative detection of ureteral kinking during pelvic floor surgery." Int Urogynecol J. 2024;35(3):689–694. doi:10.1007/s00192-024-05745-z