Urological Archives - Focused Ultrasound Foundation

Urinary Obstruction

mmayes — Fri, 08 Dec 2023 16:02:40 +0000

Focused Ultrasound Therapy

Focused ultrasound is a therapeutic technology that could transform the quality of life and decrease the cost of care for patients with urinary obstruction. This novel technology focuses beams of ultrasound energy precisely on existing urinary stents that have become obstructed deep in the body without damaging surrounding normal tissue.

How it Works
Where the beams converge, focused ultrasound produces repeated bursts of energy that have been shown in a preclinical setting to disrupt the encrustations on removed urinary stents and allow them to be recanalized. The current practice is to have surgery to remove non-functioning stents and replace them with new ones. The plan is to use this approach to lengthen the time between stent replacements.

The primary option for treatment of urinary obstruction due to stent occlusion is to have invasive surgery for stent replacement. While significant work has been accomplished, there is still much to be done before this technology will be widely available.

Advantages
For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as like surgical wound healing or infection – at a lower cost. Focused ultrasound can reach the desired target without damaging surrounding tissue, and it can be repeated, if necessary.

Clinical Trials

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of urinary obstruction due to an encrusted stent.

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.

Regulatory Approval and Reimbursement

Focused ultrasound treatment for urinary obstruction due to stent encrustation is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Singh R, Samaddar A, Duchene D, Waller S, Yang X. Recanalize ureteral stents with focused ultrasound. Med Phys. 2023 May 8. doi: 10.1002/mp.16447. Online ahead of print. PMID: 37153961

Click here for additional references from PubMed.

Prostate Cancer

mmayes — Mon, 24 Jan 2022 17:58:00 +0000

Find a Treatment Site or Clinical Trial

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, radiation-free method to destroy prostate tissue and treat prostate disease. Using real-time image guidance, the physician directs a focused beam of ultrasound energy to a selected volume in the patient’s prostate gland.

How it Works
Focused ultrasound energy heats and destroys the targeted tissue at the focal point within seconds. This process is repeated until the entire selected volume or the entire gland is destroyed.

Benefits

Current treatment options for prostate cancer include surgery, radiation, cryotherapy, hormone therapy, and chemotherapy. These treatment options carry risks and unwanted side effects such as urinary incontinence and erectile dysfunction. Focused ultrasound offers a treatment to patients with prostate cancer that carries fewer risks than conventional therapies. It may also be offered for patients with earlier stage disease where surgery is not yet recommended or as a salvage treatment for patients in which radiation has failed.

Advantages:

Noninvasive – no incisions, no risk of infection or bleeding, less pain, and rapid recovery
Image-guided – precision targeting with minimal damage to surrounding healthy tissue
No ionizing radiation – fewer side effects and can be safely repeated

Regulatory Authorizations

Focused ultrasound devices have been cleared to treat the prostate in approximately 50 countries, including the United States. Several systems for focused ultrasound ablation of prostate tissue are available in various geographical regions, each differing in their guidance method (ultrasound vs. magnetic resonance imaging) and approach – transrectal or transurethral.

While the Foundation attempts to keep the list of sites complete, there have been many purchases of the focused ultrasound systems. For the latest information on availability, we recommend contacting the manufacturers’ directly or using their online search functions.

There are four focused ultrasound manufacturers that are approved in the US for the ablation (destruction) of prostate tissue – Sonablate Corp., EDAP-TMS, Profound Medical, and Insightec. Sonablate and EDAP deliver care outside of the MRI facility, so they are found in surgery centers and surgical suites, as well as in hospitals.

There are additional sites that use mobile focused ultrasound equipment. These sites may not be listed on the EDAP, Sonablate, or Profound Medical sites, and the best way to find them is to contact local urologists to see if they have focused ultrasound capability.

Reimbursement for primary treatment in the US has been lagging, and Medicare and most insurance companies are either covering a portion of the expense or not covering it at all. In the specific instance of salvage therapy after failed radiation, some Medicare providers and commercial insurance carriers are covering focused ultrasound use in this setting. As always, it is best to check with your specific carrier.

Clinical Trials

The PRISM clinical trial in New York is investigating the rates of recurrence after HIFU treatment.

A second clinical trial in New York is evaluating clinical outcome for patients that have had HIFU treatment.

A clinical trial in Florida is looking at patients quality of life outcomes, with localized radiorecurrent prostate cancer when treated with a the Focal One device.

A clinical trial in California is comparing treatment of prostate cancer with thermal ablation or with cryotherapy.

A clinical trial in Southern California is comparing the outcomes for different focal therapy devices for treatment of prostate cancer.

A registry for the TULSA-PRO is tracking patient outcomes for this device.

A multi-site clinical trial in the US, Canada and Finland is completing a randomized trial comparing the TULSA PRO to radical prostatectomy.  

A clinical trial in Ohio is comparing a single port robotic, partial prostatectomy to focused ultrasound in patients with prostate cancer.

A clinical trial in Southern California is evaluating quality of life questionnaires for patients that have had Sonablate treatments for prostate cancer.

A clinical trial in Bethesda, Maryland is evaluating patients who are having the Tulsa-Pro treatment for low volume and low grade prostate cancer.

A clinical trial in Minnesota is evaluating the use of the Tulsa-Pro for intermediate level patients who have prostate cancer.

A clinical trial in London, UK is doing a long term study of patients treated with the Sonablate system for prostate cancer.

A clinical trial in France is evaluating different methods of target analysis for treatment of patients with prostate cancer.

A clinical trial in the Netherlands is evaluating the focal therapy for patients with prostate cancer.

A clinical trial in Norway is comparing HIFU to active surveillance.

A clinical trial in China is substitution focused ultrasound for one of the chemotherapies in patients with metastatic prostate cancer.

A clinical trial in China is comparing the quality of life outcomes from patient who had the Sonablate HIFU system to those that have had prostatectomy.

A clinical trial in Singapore is evaluating a variety of focal therapies, including focused ultrasound, for the use in patients with prostate cancer.

A clinical trial in France is organizing, and will look at the quality of life outcomes from patients who have had either total prostatectomy of focal therapy for prostate cancer.

A clinical trial, the Jupiter Registry, is organizing in Europe for looking at 5 year outcomes after patients have had focal therapy for prostate cancer.

Manufacturers

Media & Videos

Shreveport hospital first in region to offer noninvasive prostate cancer treatment
Shreveport Times – December 6, 2022

A new treatment option for men battling prostate cancer
ABC15 Arizona – November 15, 2022

WVXU: High-intensity focused ultrasound a new treatment option for men with prostate cancer
UC News – September 19, 2022

Alternative Approach Uses Sound Waves to Treat Prostate Cancer
UC San Diego Health – February 24, 2022

MRI-guided HIFU show strong potential in localized prostate cancer
Urology Times – February 4, 2021

Notable Papers

Suggested Reading: Focused Ultrasound for Prostate Cancer Case Study (2021)

Roldan-Testillano R, Rodriguez-Sanchez L, Covarrubias C, Durazo-Ruiz F, Arezki A, Anidjar M, Sanchez-Salas R. Advances in focal therapy for prostate cancer: current modalities, outcomes, and future directions. Prostate Int. 2026 Mar;14(1):1-9. doi: 10.1016/j.prnil.2025.07.002. Epub 2025 Jul 14. PMID: 41908235

Brazão ÉS Jr, Santos VE, Mourão TC, Gomes DC, Nobre JQC, Brazão GP, de Oliveira RAR, da Silva C, da Costa WH, Guimarães GC, Zequi SC. External validation of the cancer of the prostate risk assessment score to predict treatment failure after high-intensity focused ultrasound. Prostate Int. 2026 Mar;14(1):22-28. doi: 10.1016/j.prnil.2025.09.002. Epub 2025 Sep 12. PMID: 41908230

Anceschi U, Tufano A, Tuderti G, Mastroianni R, D’Annunzio S, Ferriero MC, Proietti F, Capecchi L, Spadaro G, Iori M, Misuraca L, Lugnani F, Simone G. Predicting 1-Year Trifecta Outcomes After High-Intensity Focused Ultrasound and Cryoablation for Low- and Intermediate-Risk Prostate Cancer. Biomedicines. 2026 Mar 20;14(3):716. doi: 10.3390/biomedicines14030716. PMID: 41898360

Anceschi U, Basile S, Misuraca L, Mastroianni R, D’Annunzio S, Proietti F, Bove AM, Prata F, Capecchi R, Spadaro G, Ferriero M, Lugnani F, Simone G. Hemigland cryoablation versus high-intensity focused ultrasound for localized prostate cancer: a propensity-weighted comparison of functional and oncologic outcomes. World J Urol. 2026 Mar 26;44(1):269. doi: 10.1007/s00345-026-06378-1. PMID: 41885967

Zhu D, Malshy K, Cheng Z, Mali K, Shen M, Bandari J, Hollenberg GM, Weinberg EP, Frye TP. Comparison of the Prostate Imaging After Focal Ablation (PI-FAB) and Transatlantic Recommendations for Prostate Gland Evaluation (TARGET) for the Detection of In-Field Prostate Cancer Recurrence on Post-Focal Therapy Prostate Magnetic Resonance Imaging (MRI). Clin Genitourin Cancer. 2026 Apr;24(3):102523. doi: 10.1016/j.clgc.2026.102523. Epub 2026 Feb 18. PMID: 41807146

Velasquez EL, Titus RS, Mundra V, Riveros C, Miles B, Kaushik D, Abreu AL, Wallis CJD, Satkunasivam R. Real-world functional and oncologic outcomes of prostate gland ablation vs. standard of care therapies for localized prostate: A retrospective cohort study using the TriNetX database. Urol Oncol. 2026 Mar 1;44(5):111037. doi: 10.1016/j.urolonc.2026.111037. PMID: 41771218

Biolatti LV, Ismail N, Devi A, Zhong J, Bleaney CW, Choudhury A. Unravelling Salvage Re-irradiation for Locally Recurrent Prostate Cancer: Challenges and Complexities. Clin Oncol (R Coll Radiol). 2026 Apr;52:104071. doi: 10.1016/j.clon.2026.104071. Epub 2026 Jan 31. PMID: 41759222

Ono Y, Kohada Y, Tasaka S, Miyamoto S, Hayashi T, Honda Y, Kitamura N, Tasaka R, Kobatake K, Sekino Y, Kitano H, Goto K, Goriki A, Hieda K, Kato M, Takeshima Y, Hinata N. Combining Prostate-Specific Antigen Density With PI-RADS to Improve the Detection of Clinically Significant Prostate Cancer at MRI/TRUS Fusion-Targeted Re-Biopsy. Prostate. 2026 Apr;86(5):582-591. doi: 10.1002/pros.70117. Epub 2025 Dec 23. PMID: 41431453

Watfa M, Soputro NA, Al-Bayati A, Daher K, Younis S, Rai S, Bernardino RM, Wang L, Schwen ZR, Olivares R, Autorino R, Kaouk J. Salvage Single-Port Transvesical Robotic Radical Prostatectomy Following High-Intensity Focused Ultrasound (HIFU) Therapy. Int Braz J Urol. 2026;52(3):e20250744. doi: 10.1590/S1677-5538.IBJU.2025.0744. PMID: 41643054

Light A, Peters M, Arya M, Bertoncelli Tanaka M, Dudderidge T, Emara A, Emberton M, Grey A, Hindley R, Laniado M, McCraken S, Moore CM, Nigam R, Noureldin M, Orczyk C, Reddy D, Virdi J, Ahmed M, Albisinni S, Cathcart P, Joniau S, Karnes RJ, Persad R, Rajwa P, Sanchez-Salas R, Shariat SF, Smith JA, Tilki D, van der Poel H, Calleris G, Gontero P, Marra G, Ahmed HU, Shah TT. Salvage Focal Therapy vs Radical Prostatectomy for Localized Radiorecurrent Prostate Cancer. JAMA Oncol. 2026 Feb 12:e256448. doi: 10.1001/jamaoncol.2025.6448. PMID: 41678176

Lughezzani G, Celia A, Fasulo V, Marra G, Silvestri T, Vittori G, Stabile A, Mastroianni R, Branchi A, Falagario U, Simone G, Bove P, Iacovelli V, DE Luca S, Ficarra V, Minervini A, Salonia A, Mirone V, Carrieri G, Buffi NM, Lazzeri M, Lazzeri M. The Italian Society of Urology Statement on focal therapy for localized prostate cancer. Minerva Urol Nephrol. 2026 Feb;78(1):1-14. doi: 10.23736/S2724-6051.25.06851-X. PMID: 41697201

Aksakal B, Soputro NA, Al-Bayati A, Secin M, Autorino R, Kaouk J, Olivares R. Telesurgery in prostate cancer: a systematic review of clinical applications and future directions. Prostate Cancer Prostatic Dis. 2026 Feb 20. doi: 10.1038/s41391-026-01090-y. PMID: 41721057

Cella L, Fasulo V, Moretto S, Beatrici E, Piccolini A, Avolio PP, Maffei D, Contieri R, Tallari A, Mallia V, Uleri A, Saita A, Hurle R, Casale P, Lazzeri M, Paciotti M, Buffi NM, Lughezzani G. Salvage robotic-assisted radical prostatectomy after targeted high-intensity focused ultrasound: a single-center study on feasibility, oncological and functional outcomes. Front Oncol. 2026 Feb 6;16:1711853. doi: 10.3389/fonc.2026.1711853. eCollection 2026. PMID: 41727652

Bitton RR, Vertosick E, Khandwala Y, Korol G, Vickers A, Ehdaie B, Sonn G, Ghanouni P. Optimizing prostate cancer treatment with MR-guided focused ultrasound: the role of expanded ablation-to-lesion volume ratio. Eur Radiol. 2026 Jan 16. doi: 10.1007/s00330-025-12217-5. PMID: 41540208

Roldan-Testillano R, Rodriguez-Sanchez L, Rodríguez Socarrás ME, de Andrés Boville G, Durazo-Ruiz F, Gómez Rivas J, Alfambra Fernández H, Sánchez Macías J, Bianco FJ, Miñana López B, Sanchez-Salas R. The role of focal therapy for localized prostate cancer: From diagnosis to ablation. Actas Urol Esp (Engl Ed). 2026 Jan 5:501918. doi: 10.1016/j.acuroe.2026.501918. PMID: 41500454

Dokania S, Aphale P, Shekhar H. Optimizing Transurethral Ultrasound Ablation for Localized Prostate Cancer: Lessons from Functional and Imaging Outcomes. J Vasc Interv Radiol. 2026 Jan;37(1):107890. doi: 10.1016/j.jvir.2025.10.021. Epub 2025 Oct 28. PMID: 41167300

Tricard T, Cazzato RL. Comments on Optimizing Transurethral Ultrasound Ablation for Localized Prostate Cancer: Lessons from Functional and Imaging Outcomes. J Vasc Interv Radiol. 2026 Jan;37(1):107894. doi: 10.1016/j.jvir.2025.10.025. Epub 2025 Oct 27. PMID: 41161408

Li H, Cai Z, He P, Wu Y, Lu L, Gao Y, Sun L, Huang L, Dong X, Liu Z. Mechanical destruction of canine prostate using a novel low-intensity histotripsy based on a perfluoropentane-filled sodium alginate scaffold. Int J Hyperthermia. 2025 Dec;42(1):2579893. doi: 10.1080/02656736.2025.2579893. Epub 2025 Oct 29. PMID: 41158084

Maurer A, Muehlematter UJ, Sivakumar T, Mortezavi A, Heimer J, Kaufmann B, Beintner-Skawran S, Messerli M, Huellner MW, Eberli D, Burger IA. High-Intensity Focused Ultrasound in Prostate Cancer: Can PSMA PET Improve Focal Therapy Outcomes? J Nucl Med. 2025 Dec 4:jnumed.125.271318. doi: 10.2967/jnumed.125.271318. PMID: 41344858

Collins K, Cheng L. Treatment-related changes in the prostate: past, present and future therapies. Histopathology. 2026 Jan;88(1):40-52. doi: 10.1111/his.15507. PMID: 41384710

Koehler J, Lama D, Mendez M, Hsu WW, Oto A, Szmulewitz R, Sidana A. Phase II trial protocol of focal prostate ablation combined with androgen deprivation therapy for prostate cancer treatment. PLoS One. 2025 Dec 16;20(12):e0337828. doi: 10.1371/journal.pone.0337828. eCollection 2025. PMID: 41401176

Mercier J, Bento L, Cassou-Mounat T, Prudhomme T, Lagarde S, Game X, Soulie M, Thoulouzan M, Bajeot AS, Roumiguie M. Post-HIFU surveillance of localized prostate cancer: role of PSMA-PET imaging versus the standard PSA-mpMRI protocol. World J Urol. 2025 Dec 27;44(1):68. doi: 10.1007/s00345-025-06163-6. PMID: 41454965

Yee CH, Chiu PK, Liu AQ, Wong HF, Chan WHC, Lo KL, Chan CK, Chan R, Cho CC, Hung HY, Teoh JYC, Ng CF. Multimodality focal therapy for prostate cancer: outcome of the à la carte approach in clinical practice. Prostate Int. 2025 Dec;13(4):201-206. doi: 10.1016/j.prnil.2025.03.006. Epub 2025 Mar 24. PMID: 41472926

Korn SM, Qian Z, Zurl H, Piccolini A, Pohl KK, Xiao B, Lipsitz S, Zhang J, Kibel AS, Hübner NA, Moore CM, Shariat SF, Trinh QD, Cole AP. Claims-Based Analysis of National Utilization Patterns and Regional Variability of Prostate Cancer Ablative Therapies: A Medicare Study. J Endourol. 2025 Nov 18. doi: 10.1177/08927790251388065. PMID: 41253389

Noun J, Blachman-Braun R, Lee E, Pinto PA. Focal Therapies for Localized Prostate Cancer. Urol Clin North Am. 2026 Feb;53(1):115-134. doi: 10.1016/j.ucl.2025.09.010. Epub 2025 Nov 5. PMID: 41265994

Torres J, Accary V, Payen T, Delattre V, Lafon C. Acoustic focal characteristics of a transrectal phased array under heterogeneity and weak nonlinearity. J Acoust Soc Am. 2025 Nov 1;158(5):4146-4158. doi: 10.1121/10.0039947. PMID: 41283708

Ehrengut C, Alberalar ND, Franz T, Horn LC, Blana A, Hadaschik B, Stolzenburg JU, Schlemmer HP, Ebel S, Timm Denecke S, Ganzer R, Schaudinn A. Evaluation of the TARGET score for MRI-based detection of prostate cancer recurrence in patients treated with HIFU hemiablation. Eur J Radiol. 2025 Nov 24;195:112572. doi: 10.1016/j.ejrad.2025.112572. PMID: 41319370

Ivey MC, Deivasigamani S, Kotamarti S, Mottaghi M, Ghoreifi A, Adams ES, Jhaveri H, Robertson CN, Kruse DE, Kalisz KR, Marin D, Thomas SP, Polascik TJ, Gupta RT. External validation of inter-reader reliability of the Prostate Imaging after Focal Ablation (PI-FAB) scoring system following focal cryoablation and focal high-intensity focused ultrasound. Eur Radiol. 2025 Nov;35(11):7004-7012. doi: 10.1007/s00330-025-11513-4. Epub 2025 Apr 2. PMID: 40172640

Kaplan-Marans E, Edwards C, West M, Katlowitz YE, Vazquez-Rivera K, Schulman A, Silver D. Cryotherapy and High-Intensity Focused Ultrasound: National Utilization Trends (2016-2022). Urol Pract. 2025 Nov;12(6):648-651. doi: 10.1097/UPJ.0000000000000856. Epub 2025 Jul 8. PMID: 40536487

Yeh HT, Liu YY, Chang YL, Liu HY, Shen YC, Wang HJ, Chen YT, Chuang YC, Luo HL. 10-year oncological outcomes of EBRT versus HIFU for stage II prostate cancer: a multicenter Chang Gung research database (CGRD) study with inverse-probability-of-treatment weighting (IPTW) analysis. Int Urol Nephrol. 2025 Oct 7. doi: 10.1007/s11255-025-04805-7. PMID: 41055797

Khanal N, Marciniak MA, Daniel MC, Zhu L, Dumoulin C, Stringer K, Myers MR, Yarmolenko P, Banerjee RK. Assessing Fab-Functionalized Gold Nanoparticles-Mediated Thermal Enhancement during High-Intensity Focused Ultrasound Ablation in a Mouse Tumor Model. ACS Appl Bio Mater. 2025 Oct 13. doi: 10.1021/acsabm.5c00879. PMID: 41081487

Ploussard G, Baboudjian M, Barret E, Brureau L, Dariane C, Fiard G, Fromont G, Mathieu R, Olivier J, Neuzillet Y, Rozet F, Peyrottes A, Renard-Penna R, Sargos P, Supiot S, Turpin L, Roubaud G, Rouprêt M. French recommendations from the AFU Cancer Committee for prostate cancer: 2025 summary of changes. Fr J Urol. 2025 Oct 16;35(12):103010. doi: 10.1016/j.fjurol.2025.103010. PMID: 41109641

Eskandar K. FocalONE high-intensity focused ultrasound for localized prostate cancer: A systematic review of oncologic outcomes, functional preservation, and technological evolution. Actas Urol Esp (Engl Ed). 2025 Oct 22:501869. doi: 10.1016/j.acuroe.2025.501869. PMID: 41135772

Johnson K, Mehan R. Removal of Prostate Calcifications Prior to TULSA-PRO With the Aid of Real-Time Ultrasound Imaging: Our Technique and Experience. Cureus. 2025 Sep 23;17(9):e92995. doi: 10.7759/cureus.92995. eCollection 2025 Sep. PMID: 40994761

Chang M, Lv J, Sun L, Chen A, Zhang F, Fan G, Liu Z, Li J, Shen H, Shi M, Niu Y, Tian Y, Liu X, Yang B. Cu-Mn Bimetallic Mesoporous Silica Nanosonosensitizers Enable Oxeiptosis-Mediated Sonodynamic Therapy for Ultra-Minimally Invasive Treatment of Benign Prostatic Hyperplasia. ACS Appl Mater Interfaces. 2025 Sep 17;17(37):51820-51839. doi: 10.1021/acsami.5c12846. Epub 2025 Sep 5. PMID: 40911431

Xiao B, Qian Z, Piccolini A, Dagnino F, Korn SM, Zurl H, Pohl KK, Stelzl DR, Moore CM, Wollin D, Trinh QD, Cole AP. Medicolegal landscape of prostate cancer ablative therapy: a national legal database analysis of malpractice claims (1970-2024). Int Urol Nephrol. 2025 Sep 9. doi: 10.1007/s11255-025-04766-x. PMID: 40926180

Scherer TP, Lazos AG, Sonderer J, Kaufmann B, Schmid FA, Jenewein J, Rupp NJ, Moch H, Eberli D, Mortezavi A. Anxiety and Health-related Quality of Life in Men with Prostate Cancer Undergoing Focal Therapy: A Prospective Single-arm Phase 2 Trial. Eur Urol Focus. 2025 Sep 9:S2405-4569(25)00253-6. doi: 10.1016/j.euf.2025.08.006. PMID: 40930919

Khanal N, Summey V, Bailey J, Duan X, Zheng Y, Zhu L, Stringer K, Rao M, Banerjee RK. Development of Mouse-Tumor Model Using Prostate Cancer (PC3) Cell Line for High-Intensity Focused Ultrasound (HIFU) Ablation. Prostate Cancer. 2025 Sep 6;2025:5678314. doi: 10.1155/proc/5678314. eCollection 2025. PMID: 40950564

Cormio A, Castellani D. Editorial Comment on “Medium-Term Outcomes after Primary Whole-Gland High-Intensity Focused Ultrasound Ablation for the Treatment of Prostate Cancer: A Single-Center Experience”. J Endourol. 2025 Jul 3. doi: 10.1089/end.2025.0425. PMID: 40608541

Wenzel M, Nathan A, Covas Moschovas M, Wagner C, Calleris G, Di Maida F, Gomez Rivas J, Bravi CA, De Groote R, Piramide F, Turri F, Kowalczyk K, Würnschimmel C, Sharma G, Andras I, Lambert E, Liakos N, Darlington D, Paciotti M, Sorce G, Mandel P, Galfano A, Nathan S, Marra G, Dell’Oglio P, Mottrie A, Chun FKH, Patel V, Breda A, Larcher A. Oncological Outcomes After Robotic Salvage Radical Prostatectomy in Patients Primarily Treated With Focal Versus Radiation Therapy: A Junior ERUS/YAU Collaborative Study. Prostate. 2025 Jul 23. doi: 10.1002/pros.70020. PMID: 40702693

Lepine HL, Vicentini FC, Filho CM, Cavalcante G, Llata FM, Júnior JB, Reis LO, Mota JM, Nahas WC, Ribeiro-Filho LA, Suartz CV. Evaluating less-invasive strategies for localized prostate cancer: a comparative meta-analysis on high-intensity focused ultrasound versus radical prostatectomy. Int Urol Nephrol. 2025 Jul 31. doi: 10.1007/s11255-025-04695-9. PMID: 40742653

Shee K, Pace WA, Liu AW, Cowan JE, Subramanyam V, Agapito C, Washington SL 3rd, Cooperberg MR, Carroll PR, Shinohara K, Nguyen HG. Determining Optimal Patient Selection for High-intensity Focused Ultrasound for Prostate Cancer. Eur Urol Focus. 2025 Aug 2:S2405-4569(25)00174-9. doi: 10.1016/j.euf.2025.06.007. PMID: 40754483

Rosnitskiy PB, Thomas GPL, Lee GL, Khokhlova VA, Sapozhnikov OA, Schade GR, Morrison KP, Chavez F, Khokhlova TD. A Fully Populated Transrectal Array for Boiling Histotripsy Ablation of the Prostate. IEEE Trans Ultrason Ferroelectr Freq Control. 2025 Aug 7;PP. doi: 10.1109/TUFFC.2025.3596780. PMID: 40773382

Kaneko M, Ramacciotti LS, Inoue Y, Peretsman S, Cummins J, Cai J, Halteh P, Palmer S, Aron M, Ukimura O, Gill IS, Abreu AL. Impact of magnetic resonance imaging visibility of prostate cancer on partial gland ablation. BJUI Compass. 2025 Aug 6;6(8):e70065. doi: 10.1002/bco2.70065. eCollection 2025 Aug. PMID: 40777065

Katano A, Minamitani M, Sawayanagi S, Yamashita H. Salvage Radiation Therapy for Localised Prostate Cancer Recurrence Following High-Intensity Focused Ultrasound (HIFU) Failure. J Med Imaging Radiat Oncol. 2025 Aug 15. doi: 10.1111/1754-9485.70009. PMID: 40817649

Artiles Medina A, Tagalos Muñoz A, Domínguez Gutiérrez A, Muriel García A, Subiela JD, Álvarez Díaz N, Fernández Conejo G, Gómez Dos Santos V, Coloma Del Peso A, Burgos Revilla FJ. Outcomes of Active Treatment for Localised Prostate Cancer After Holmium Laser Enucleation of the Prostate: A Systematic Review and Meta-analysis. Eur Urol Open Sci. 2025 Aug 11;79:111-127. doi: 10.1016/j.euros.2025.07.011. eCollection 2025 Sep. PMID: 40837058

Pyrgidis N, Chaloupka M, Ebner B, Volz Y, Weinhold P, Marcon J, Eismann L, Stief CG, Schulz GB, Apfelbeck M. Perioperative complications of focal therapy for prostate cancer: results from the GeRmAn Nationwide inpatient Data (GRAND) study. BJU Int. 2025 Aug;136(2):306-313. doi: 10.1111/bju.16746. Epub 2025 Apr 19. PMID: 40251973

Creta M, Shariat SF, Marra G, Gontero P, Rossanese M, Morra S, Teoh J, Kishan AU, Karnes RJ, Longo N. Local salvage therapies in patients with radio-recurrent prostate cancer following external beam radiotherapy: a systematic review and meta-analysis. Prostate Cancer Prostatic Dis. 2025 Sep;28(3):578-591. doi: 10.1038/s41391-024-00883-3. Epub 2024 Sep 2. PMID: 39223232

Séguier D, Puech P, Barret E, Leroy X, Labreuche J, Penna RR, Ploussard G, Villers A, Olivier J. MRI accuracy for recurrence after partial gland ablation with HIFU for localized prostate cancer. A systematic review and meta-analysis. Prostate Cancer Prostatic Dis. 2025 Sep;28(3):592-600. doi: 10.1038/s41391-024-00885-1. Epub 2024 Sep 10. PMID: 39256551

Shoji S, Naruse J, Ohno S, Aoki M, Takahashi K, Yuzuriha S, Kuroda S, Umemoto T, Nakajima N, Hasegawa M, Kawamura Y, Kajiwara H, Hashida K, Uemura K, Hasebe T, Tajiri T. Focal therapy using high-intensity focused ultrasound with intraoperative prostate compression for patients with localized prostate cancer: a multi-center prospective study with 7 year experience. Prostate Cancer Prostatic Dis. 2025 Sep;28(3):782-788. doi: 10.1038/s41391-024-00921-0. Epub 2024 Nov 23. PMID: 39580599

Taratkin M, Androsov A, Morozov A, Azilgareeva C, Rivas JG, Puliatti S, Checcucci E, Belenchon IR, Kowalewski KF, Rodler S, Piazza P, Baekelandt L, Veccia A, De Backer P, Fajkovic H, Enikeev D, Cacciamani GE. Urinary Outcomes of Minimally Invasive Treatments for Prostate Cancer-A Systematic Review by Young Academic Urologists’ Urotechnology Working Group. J Endourol. 2025 Jun 10. doi: 10.1089/end.2024.0129. PMID: 40491395

Piramide F, Veccia A, Tzelves L, Nikles S, Ortega Polledo LE, Nocera L, Khelif A, Dumbovic L, Lazarou L, Cisero E, Quarà A, Sterrantino A, Falagario U, Piazza P, Baekealndt L, Carrion DM, Gomez Rivas J, Cacciamani G, Checcucci E. Sexual function outcomes in men undergoing minimal invasive ablative techniques for prostate cancer: a ESRU/YAU urotech systematic review and pooled analysis. Minerva Urol Nephrol. 2025 Jun;77(3):285-297. doi: 10.23736/S2724-6051.25.06007-0. PMID: 40528769

Shoji S, Takahashi K, Naruse J, Kawamura Y. Frontiers of Ultrasound Technology in Prostate Cancer Treatment. Int J Urol. 2025 Jun 22. doi: 10.1111/iju.70160. PMID: 40545780

Sotoudehnia S, Leung BYC, Thompson SM, Adamo DA, Mynderse LA, Woodrum DA. Saline Displacement of Rectal Wall for Improved Margin During MRI-Guided Transurethral Ultrasound Ablation (TULSA). Cardiovasc Intervent Radiol. 2025 Jun 24. doi: 10.1007/s00270-025-04102-x. PMID: 40555770

Bhattarai R, McKenney JK, Alaghehbandan R, Liu X, Cox RM, Myles JL, Przybycin CG, Williamson SR, Weight CJ, Schwen Z, Nguyen JK. Atypical Intraductal Proliferation in Prostate Needle Core Biopsy: Validation as a Marker of Unsampled Adverse Pathology in a Clinicopathologic Series of 142 New Patients. Am J Surg Pathol. 2025 May 1;49(5):515-522. doi: 10.1097/PAS.0000000000002376. Epub 2025 Feb 25. PMID: 39995242

Rischmann P, Occéan BV, Ploussard G. Reply to Mario Terlizzi, Youssef Ghannam, and Pierre Blanchard’s Letter to the Editor re: Guillaume Ploussard, Patrick Coloby, Thierry Chevallier, et al. Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Eur Urol. 2025;87:526-533. Eur Urol. 2025 May;87(5):e92. doi: 10.1016/j.eururo.2025.02.018. Epub 2025 Mar 6. PMID: 40055030

Brazão ÉS Jr, Oliveira RAR, Zanotti RR, Gomes DC, Mourão TC, Santos VE, da Silva C, Santana TBM, da Costa WH, Guimarães GC, Zequi SC. Medium-Term Outcomes after Primary Whole-Gland High-Intensity Focused Ultrasound Ablation for the Treatment of Prostate Cancer: A Single-Center Experience. J Endourol. 2025 May;39(5):500-508. doi: 10.1089/end.2024.0539. Epub 2025 Mar 26. PMID: 40135250

Schröer S, Glandorf J, Düx D, Horstmann D, Gutt M, Belker O, Peters I, Hellms S, Wacker F, Hensen B, Gutberlet M. Improving necrosis estimation in MR-guided prostate focused ultrasound ablations with a probabilistic thermal dose model. Comput Biol Med. 2025 Jun;192(Pt B):110225. doi: 10.1016/j.compbiomed.2025.110225. Epub 2025 May 16. PMID: 40381478

Viitala A, Anttinen M, Mäkelä P, Pärssinen H, Nurminen P, Sainio T, Saunavaara J, Taimen P, Sequeiros RB, Boström PJ. Magnetic resonance imaging-guided transurethral ultrasound ablation for benign prostatic obstruction: 1-year clinical outcomes of a phase II study. BJU Int. 2025 May 28. doi: 10.1111/bju.16795. PMID: 40432395

Zhou H, Tang J, Wan Y, Gong J, Wang Q, Huang K, Hong R, Xu X, Li F. Platform-based BST-2-targeted microbubbles enhance HIFU therapy and effectively inhibit prostate cancer residual growth. Int J Hyperthermia. 2025 Dec;42(1):2511035. doi: 10.1080/02656736.2025.2511035. Epub 2025 May 28. PMID: 40436774

Tricard T, Cazzato RL, Schroeder A, De Mathelin M, Barhoumi C, Gaillard V, Sauleau E, Gangi A, Lang H. Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer (MRI-TULSA): A Prospective Trial. J Vasc Interv Radiol. 2025 May 27:S1051-0443(25)00385-9. doi: 10.1016/j.jvir.2025.05.024. PMID: 40441432

Viani GA, Hamamura AC. Re: Guillaume Ploussard, Patrick Coloby, Thierry Chevallier, et al. Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Eur Urol. In press. Eur Urol. 2025 May 30:S0302-2838(25)00204-0. doi: 10.1016/j.eururo.2025.02.032. PMID: 40450474

Bertelli E, Vizzi M, Legato M, Nicoletti R, Paolucci S, Ruzga R, Giovannelli S, Sessa F, Serni S, Masieri L, Campi R, Neri E, Agostini S, Miele V. The Use of PI-FAB Score in Evaluating mpMRI After Focal Ablation of Prostate Cancer: Is It Reliable? Inter-Reader Agreement in a Tertiary Care Referral University Hospital. Cancers (Basel). 2025 Mar 20;17(6):1031. doi: 10.3390/cancers17061031. PMID: 40149364

Ghai S, Ni TT, Pavlovich CP, Futterer JJ, Schade GR, Sanchez-Salas R, Cornud F, Eggener S, Feller JF, George AK, Villers A, de la Rosette J. New kids on the block: MRI guided transrectal focused US, TULSA, focal laser ablation, histotripsy – a comprehensive review. Prostate Cancer Prostatic Dis. 2025 Mar 27. doi: 10.1038/s41391-025-00956-x. PMID: 40140552

Engelage L, Muschter R. Transurethral Ultrasound Ablation for Treatment of Localized Prostate Cancer and Benign Prostatic Hyperplasia (BPH). J Endourol. 2025 Mar;39(S1):S23-S26. doi: 10.1089/end.2024.0301. PMID: 40100835

Ajami T, Williams A, Ryan JT, Prakash NS, Khandekar A, Sureshkumar K, Ritch CR, Gonzalgo ML, Punnen S, Parekh DJ, Nahar B. Use of biochemical and imaging criteria for selecting patients for prostate biopsy in recurrence risk assessment post-HIFU therapy. World J Urol. 2025 Mar 12;43(1):162. doi: 10.1007/s00345-025-05529-0. PMID: 40072595

Pausch AM, Elsner C, Rupp NJ, Eberli D, Hötker AM. Comparative analysis of TARGET and PI-FAB scores in mpMRI surveillance after HIFU therapy for localized prostate cancer. Eur J Radiol. 2025 Mar 4;186:112028. doi: 10.1016/j.ejrad.2025.112028. PMID: 40058174

Terlizzi M, Ghannam Y, Blanchard P. Re: Guillaume Ploussard, Patrick Coloby, Thierry Chevallier, et al. Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Eur Urol. In press. Eur Urol. 2025 Mar 4:S0302-2838(25)00121-6. doi: 10.1016/j.eururo.2025.01.027. PMID: 40044505

Baude J, Teyssier C, Barbier V, Tremeaux JC, Azélie C, Lépinoy A, Henry PC, Bailly V, Lescut N, Lagneau E, Schipman B. Salvage radiotherapy with volumetric modulated arc therapy (VMAT) for recurrent prostate cancer after high-intensity focused ultrasound (HIFU): A large French retrospective series and literature review. Radiother Oncol. 2025 Feb;203:110665. doi: 10.1016/j.radonc.2024.110665. Epub 2024 Dec 15. PMID: 39681174

Hedhli O, Marra G, Karam G, Glemain P, Chelghaf I, De Vergie S, Perrouin Verbe MA, Biancone L, Gontero P, Bouchot O, Rigaud J, Branchereau J. Prostate cancer in solid organ transplant recipients: Results from a multicenter series. Fr J Urol. 2025 Mar;35(2):102841. doi: 10.1016/j.fjurol.2024.102841. Epub 2024 Dec 4. PMID: 39643043

Sidana A, Lazarovich A, Tayebi S, Huron A, Blank F, Tobler J, Verma S, Hsu WW. Prostate ablation for the management of localized prostate cancer. Urol Oncol. 2025 Mar;43(3):194.e9-194.e17. doi: 10.1016/j.urolonc.2024.11.009. Epub 2024 Nov 26. PMID: 39592359

Kumar R, Ghai S, Finelli A, Klotz L, Kinnaird A, Mannas M, Bhindi B, Sanchez-Salas R, Anidjar M, Ahmad A, Chin J, Inman B, Perlis N. The use of focal therapy for the treatment of prostate cancer in Canada Where are we, how did we get here, and where are we going? Can Urol Assoc J. 2025 Feb;19(2):63-72. doi: 10.5489/cuaj.8888. PMID: 39418491

Tamburini S, Bianchi L, Piazza P, Mottaran A, Ercolino A, Rotaru V, Pirelli V, Presutti M, Droghetti M, Schiavina R, Brunocilla E. Current role of focal therapy in prostate cancer. Urologia. 2025 Feb;92(1):67-74. doi: 10.1177/03915603241258713. Epub 2024 Nov 14. PMID: 39540262

Rischmann P, Occéan BV, Ploussard G. Reply to Jason Koehler and Abhinav Sidana’s Letter to the Editor re: Guillaume Ploussard, Patrick Coloby, Thierry Chevallier, et al. Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2024.11.006. Eur Urol. 2025 Feb 6:S0302-2838(25)00062-4. doi: 10.1016/j.eururo.2025.01.022. PMID: 39920006

Bochner E, Schulte V, Lotan Y, Meng X, Costa DN. Feasibility and Short-Term Safety of Hydrogel Spacer before Treatment with Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation for Prostate Cancer Treatment. J Endourol. 2025 Feb 10. doi: 10.1089/end.2024.0700. PMID: 39925110

Montorsi F, Gandaglia G, Stabile A. Re: Guillaume Ploussard, Patrick Coloby, Thierry Chevallier, et al. Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Eur Urol. In press. Eur Urol. 2025 Feb 15:S0302-2838(25)00063-6. doi: 10.1016/j.eururo.2025.01.023. PMID: 39956725

Hsieh PF, Naruse J, Yuzuriha S, Umemoto T, Huang CP, Shoji S. Combining Percentage Prostate-Specific Antigen Reduction and Multiparametric Magnetic Resonance Imaging to Reduce Unnecessary Biopsy After Focal Therapy With High-Intensity Focused Ultrasound for Prostate Cancer. Int J Urol. 2025 Feb 19. doi: 10.1111/iju.70013. PMID: 39968685

Matsuoka Y. Editorial Comment to “Combining Percentage Prostate-Specific Antigen Reduction and Multiparametric Magnetic Resonance Imaging to Reduce Unnecessary Biopsy After Focal Therapy With High-Intensity Focused Ultrasound for Prostate Cancer“. Int J Urol. 2025 Feb 27. doi: 10.1111/iju.70031. PMID: 40012537

Muhler P, Akuamoa-Boateng D, Rosenbrock J, Stock S, Müller D, Heidenreich A, Simões Corrêa Galendi J. Cost-utility analysis of MR imaging-guided transurethral ultrasound ablation for the treatment of low- to intermediate-risk localised prostate cancer. BMJ Open. 2025 Jan 11;15(1):e088495. doi: 10.1136/bmjopen-2024-088495. PMID: 39800402

Teoh JY, Wong CH. When precision meets prostate cancer: the rising role of HIFU focal therapy. Prostate Cancer Prostatic Dis. 2025 Jan 20. doi: 10.1038/s41391-025-00940-5. PMID: 39833291

Su S, Wang Y, Lo EM, Tamukong P, Kim HL. High-intensity focused ultrasound ablation to increase tumor-specific lymphocytes in prostate cancer. Transl Oncol. 2025 Jan 24;53:102293. doi: 10.1016/j.tranon.2025.102293. PMID: 39862483

Koehler J, Sidana A. Re: Guillaume Ploussard, Patrick Coloby, Thierry Chevallier, et al. Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2024.11.006. Eur Urol. 2025 Jan 24:S0302-2838(25)00021-1. doi: 10.1016/j.eururo.2024.12.021. PMID: 39863507

Koehler J, Lazarovich A, Tayebi S, Viswanath V, George A, Hsu WW, Sidana A. Shifting tides: A survey analysis of urologists’ evolving attitudes toward focal therapy for prostate cancer. Indian J Urol. 2025;41(1):59-65. doi: 10.4103/iju.iju_239_24. Epub 2025 Jan 1. PMID: 39886635

Click here for additional references from PubMed.

Video courtesy of SonaCare Medical

Bladder Tumors

mmayes — Wed, 08 Dec 2021 23:52:00 +0000

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with bladder tumors. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.

How the Works
Where the beams converge, focused ultrasound produces precise ablation (thermal destruction of tissue) enabling bladder tumors to be treated without surgery.

One preclinical study in the 1990s found that focused ultrasound could be used to destroy bladder tissue. There has been some recent work looking at the concept of using focused ultrasound to provide organ sparing surgery for patients with bladder cancer at UCLA. This preclinical work showed that one can use focused ultrasound in a transmural, full thickness ablation of an intact bladder wall. Further work needs to be done to demonstrate the impact of these approaches in patient care.

Advantages
The primary options for treatment of bladder cancer include medication and invasive surgery.

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. Focused ultrasound can also reach the desired target without damaging surrounding tissue, and it can be repeated, if necessary.

Clinical Trials

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of bladder tumors.

Find a Treatment Site

Search for a treatment center or clinical trial near you.

Regulatory Approval and Reimbursement

Focused ultrasound treatment for bladder tumors is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Delattre V, Cambronero S, Chen Y, Haar GT, Rivens I, Polton G, Lafon C, Melodelima D. In vivo exposure of the bladder using a non-invasive high intensity focused ultrasound toroidal transducer. Ultrasonics. 2024 Jan 3;138:107239. doi: 10.1016/j.ultras.2024.107239. PMID: 38211366

Panzone J, Byler T, Bratslavsky G, Goldberg H. Applications of Focused Ultrasound in the Treatment of Genitourinary Cancers. Cancers (Basel). 2022 Mar 17;14(6):1536. doi: 10.3390/cancers14061536.

Weitz AC, Lee NS, Yoon CW, Bonyad A, Goo KS, Kim S, Moon S, Jung H, Zhou Q, Chow RH, Shung KK. Functional Assay of Cancer Cell Invasion Potential Based on Mechanotransduction of Focused Ultrasound. Front Oncol. 2017 Aug 7;7:161. doi: 10.3389/fonc.2017.00161. eCollection 2017.

de Castro Abreu AL, Ukimura O, Shoji S, Leslie S, Chopra S, Marien A, Matsugasumi T, Dharmaraja A, Wong K, Zaba N, Ma Y, Desai MM, Gill IS. Robotic transmural ablation of bladder tumors using high-intensity focused ultrasound: Experimental study. Int J Urol. 2016 Jun;23(6):501-8. doi: 10.1111/iju.13083.

Click here for additional references from PubMed.

Benign Prostatic Hyperplasia (BPH)

mmayes — Wed, 08 Dec 2021 23:51:00 +0000

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with BPH. This novel technology focuses beams of ultrasound energy precisely and accurately on targets in the body without damaging surrounding normal tissue.

How it Works
Where the beams converge, focused ultrasound produces precise ablation (thermal destruction of tissue) enabling BPH to be treated without surgery.

Advantages
The primary options for treatment of BPH include medication and invasive surgery.

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary.

Clinical Trials

There is a clinical trial using the Edison System for treatment of patients with BPH in Hong Kong.

There is a clinical trial using the EDAP TMS system for the treatment of BPH in multiple sites in France.

See a list of treatment sites >
See a list of laboratory research sites >

Find a Treatment Site

Search for a treatment center or clinical trial near you.

Regulatory Approval and Reimbursement

There are four focused ultrasound systems approved in the US for the ablation (destruction) of prostate tissue: Sonablate Corp, EDAP-TMS, Insightec and Profound Medical. Sonablate Corp and EDAP-TMS use the transrectal approach with ultrasound guidance. Insightec’s device uses a transrectal approach guided by MRI. A transurethral, MRI-guided approach is manufactured by Profound Medical, and it is approved in Europe and in the US. This has a AI component added to the treatment to make the treatment time more competitive with the other BPH treatments.

Treatment for BPH is approved in the US, Canada, China, Europe, India, Japan, Korea, Middle East, Russia, and South America. Insurance coverage varies, and many US companies may not cover this procedure.

Notable Papers

Aoun F, Marcelis Q, Roumeguère T. Minimally invasive devices for treating lower urinary tract symptoms in benign prostate hyperplasia: technology update. Res Rep Urol. 2015 Aug 19;7:125-36. doi: 10.2147/RRU.S55340. eCollection 2015.

Khokhlova VA, Fowlkes JB, Roberts WW, Schade GR, Xu Z, Khokhlova TD, Hall TL, Maxwell AD, Wang YN, Cain CA. Histotripsy methods in mechanical disintegration of tissue: towards clinical applications. Int J Hyperthermia. 2015 Mar;31(2):145-62. doi: 10.3109/02656736.2015.1007538. Epub 2015 Feb 24.

Thiruchelvam N. Surgical therapy for benign prostatic hypertrophy/bladder outflow obstruction. Indian J Urol. 2014 Apr;30(2):202-7. doi: 10.4103/0970-1591.126907.

Roberts WW. Development and translation of histotripsy: current status and future directions. Curr Opin Urol. 2014 Jan;24.

Sullivan L, Casey RW, Pommerville PJ, Marich KW. Canadian experience with high intensity focused ultrasound for the treatment of BPH. Can J Urol. 1999 Jun;6(3):799-805.

Click here for additional references from PubMed.

Kidney Disease

mmayes — Wed, 08 Dec 2021 19:50:00 +0000

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with kidney disease. This novel technology focuses beams of ultrasound energy precisely and accurately on targets in the kidney.

How it Works
Where the beams converge, focused ultrasound is being used to improve the homing and implantation of mesenchymal stem cells in the diseased kidney. Preclinical results show improved renal cell survival compared to controls. While early work is promising, there is still much to be done before this technology will be widely available.

Advantages
The primary options for treatment of kidney disease include medication, dialysis and potentially invasive surgery.

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary.

Clinical Trials

At the present time, there are no clinical trials recruiting patients for focused treatment of kidney disease.

See a list of laboratory research sites >

Find a Treatment Site

Search for a treatment center or clinical trial near you.

Regulatory Approval and Reimbursement

Focused ultrasound treatment for kidney disease is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Guo Y, Wang Y, Wang B, Peng S, Li N, Zhang D, Wu H. Ultrasound-responsive renal-targeted nanoparticles deliver TAK-242 to inhibit NF-κB/NLRP3 signaling and attenuate sepsis-associated acute kidney injury. Biomaterials. 2026 Jun;329:123922. doi: 10.1016/j.biomaterials.2025.123922. Epub 2025 Dec 14. PMID: 41481962

Kisting AL, Zlevor AM, Falk KL, Kisting MA, Laklouk IA, Wagner MG, White JK, Winterholler JE, Jentink M, Abel EJ, Knavel Koepsel EM, Hinshaw JL, Swietlik JF, Mao L, Minesinger GM, Laeseke PF, Ziemlewicz TJ, Lee FT Jr. Histotripsy of the Proximal Ureter and Renal Pelvis: Evaluation of Urothelial Injury in a Porcine Survival Model. J Vasc Interv Radiol. 2024 Dec 9:S1051-0443(24)00752-8. doi: 10.1016/j.jvir.2024.11.028. PMID: 39662616

Couillard AB, Zlevor AM, Ziemlewicz TJ, Kisting MA, Knott E, Rossebo AE, White J, Lubner MG, Gettle LM, Hinshaw JL, Mao L, Stoffregen W, Swietlik JF, Knavel-Koepsel E, Stratchko L, Abel EJ, Xu Z, Lee FT Jr, Laeseke PF. A Comparison of Histotripsy and Percutaneous Cryoablation in a Chronic Healthy Swine Kidney Model. J Vasc Interv Radiol. 2023 Nov;34(11):1986-1996. doi: 10.1016/j.jvir.2023.07.014. Epub 2023 Jul 20. PMID: 37481064

Camafort M, Ihm SH, Ruilope LM. Renal denervation for the treatment of hypertension and kidney disease. Curr Opin Nephrol Hypertens. 2023 Nov 1;32(6):544-550. doi: 10.1097/MNH.0000000000000928. Epub 2023 Sep 13. PMID: 37706512

Click here for additional references from PubMed.

Urinary Tract Infection

mmayes — Wed, 08 Dec 2021 14:15:00 +0000

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with urinary tract infections. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.

How it Works
The ultrasound beams converge on microbubbles with attached antibiotics, resulting in the antibiotic being released and allowing it to treat the endothelial wall. This can help treat the current infection and also help prevent the storage of bacteria in the wall, which leads to recurrent infections. While significant preclinical work has been accomplished, there is still much to be done before this technology will be widely available.

Advantages
The primary options for treatment of urinary tract infections include medication.

For certain patients, focused ultrasound could provide a more effective alternative to current treatment. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary. Focused ultrasound also offers enhanced treatment for the target, with less impact to the rest of the patient.

Clinical Trials

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of urinary tract infections.

Regulatory Approval and Reimbursement

Focused ultrasound treatment for urinary tract infection is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Horsley H, Owen J, Browning R, Carugo D, Malone-Lee J, Stride E, Rohn JL. Ultrasound-activated microbubbles as a novel intracellular drugdelivery system for urinary tract infection. J Control Release. 2019 May 10;301:166-175. doi: 10.1016/j.jconrel.2019.03.017. Epub 2019 Mar 20.

Click here for additional references from PubMed.

Vasectomy

mmayes — Wed, 08 Dec 2021 14:15:00 +0000

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients desiring a vasectomy. This novel technology focuses beams of ultrasound energy precisely and accurately on targets within the body without damaging surrounding normal tissue.

How it Works
Where the beams converge, focused ultrasound produces precise ablation (thermal destruction of tissue) enabling vasectomy to be accomplished with minimal (and possibly without any) invasion of the body. While significant preclinical work has been accomplished, human trials have not yet begun.

Advantages
For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications and lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary. Focused ultrasound also does not carry added concerns associated with acid agents.

Clinical Trials

At the present time, there are no clinical trials recruiting patients for focused ultrasound vasectomy.

Regulatory Approval and Reimbursement

Focused ultrasound vasectomy is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Roberts WW, Wright EJ, Fried NM, Nicol T, Jarrett TW, Kavoussi LR, Solomon SB. High-intensity focused ultrasound ablation of the epididymis in a canine model: a potential alternative to vasectomy. J Endourol. 2002 Oct;16(8):621-5.

Roberts WW, Chan DY, Fried NM, Wright EJ, Nicol T, Jarrett TW, Kavoussi LR, Solomon SB. High intensity focused ultrasound ablation of the vas deferens in a canine model. J Urol. 2002 Jun;167(6):2613-7.

Fried NM, Sinelnikov YD, Pant BB, Roberts WW, Solomon SB. Noninvasive vasectomy using a focused ultrasound clip: thermal measurements and simulations. IEEE Trans Biomed Eng. 2001 Dec;48(12):1453-9.

Click here for additional references from PubMed.

Kidney Stones

mmayes — Wed, 08 Dec 2021 18:14:00 +0000

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with kidney stones. This novel technology focuses beams of ultrasonic energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.

The FDA has granted De Novo clearance for the Stone Clear^TM device for anesthesia free treatment of post-lithotripsy stone fragments, and this was followed by the approval of the Break Wave^TM device for the breakage of kidney stones too large to pass on their own. The result is that patients can get both stones broken up and assist in directing them to pass with these tools.

How it Works
There are two mechanisms of action where this technology can help those with kidney stones.

The first mechanism is the ability to propel stones in the genitourinary track, which can be very helpful in patients with multiple stones or for those who have had extracorporeal shock wave lithotripsy (also referred to as ESWL), where there is the potential for the stone fragments to locate in the lower pole. As the energy is applied near the edge of the stone, there is an acoustic wave that spreads, resulting for stone movement.

A second mechanism of action is to use the energy in focused ultrasound to mechanically fragment the kidney stones into smaller pieces. These smaller pieces can pass through the urinary drainage system and exit in the urine. The SonoMotion’s Break Wave has recently achieved FDA approval for this purpose.

The manufacturer for this work is spin-off company from the University of Washington, SonoMotion. They do not yet have a list of commercial centers providing this care, so interested patients can contact them at info@sonomotion.com or see if there is an opportunity to participate in the clinical trials which are still recruiting patients, listed below.

Advantages
For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications and lower cost. It has the ability to noninvasively break up and relocate kidney stones, (without anesthesia) and this treatment does not require any nephrotoxic or ionizing radiation components. Focused ultrasound can also be repeated, if needed.

Clinical Trials

A multi-center clinical trial is using low intensity focused ultrasound to treat patients with kidney stones in a pivotal trial.

A multi-center clinical trial using focused ultrasound is being used to treat patients with kidney stones.

A multi-center clinical trial using low intensity focused ultrasound to break up kidney stones has been completed.

Find a Treatment Site

Search for a treatment center or clinical trial near you.

Regulatory Approval and Reimbursement

Focused ultrasound treatment of kidney stones is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Chew BH, Harper JD, Sur RL, Chi T, De S, Buckley AR, Paterson RF, Wong VKF, Forbes CM, Hall MK, Kessler R, Bechis SK, Woo JR, Wang RC, Bayne DB, Bochinski D, Schuler TD, Wollin TA, Samji R, Sorensen MD Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial J Urol. 2024 Oct;212(4):580-589

Li W, Feng T, Meng T, Guo G, Tu J, Zhang D, Ma Q. Steerable ultrasonic propulsion of rigid objects based on circular pressure modulation of a focused sectorial transducer array. Ultrasonics. 2025 Jan;145:107475. doi: 10.1016/j.ultras.2024.107475. Epub 2024 Sep 14. PMID: 39293232

Sorensen M, Dunmire B, Thiel J,  Cunitz BW, Burke BH, Levchak BJ, Popchoi C, Holmes AE, Kucewicz JC, Hall MK, Dighe M, Dai JC,  Cormack FC,  Liu Z, Bailey MR, Porter MP, Harper JD. Randomized Controlled Trial of Ultrasonic Propulsion-Facilitated Clearance of Residual Kidney Stone Fragments vs Observation. J Urol. 2024 Aug 14:101097JU0000000000004186. doi:10.1097/JU.0000000000004186. PMID: 39146526

Li W, Feng T, Meng T, Guo G, Tu J, Zhang D, Ma Q. Steerable ultrasonic propulsion of rigid objects based on circular pressure modulation of a focused sectorial transducer array. Ultrasonics. 2024 Sep 14;145:107475. doi: 10.1016/j.ultras.2024.107475. PMID: 39293232

Biasiori-Poulanges L, Lukić B, Supponen O. Cavitation cloud formation and surface damage of a model stone in a high-intensity focused ultrasound field. Ultrason Sonochem. 2023 Dec 22;102:106738. doi: 10.1016/j.ultsonch.2023.106738. PMID: 38150955

Maxwell AD, Kim GW, Furrow E, Lulich JP, Torre M, MacConaghy B, Lynch E, Leotta DF, Wang YN, Borofsky MS, Bailey MR. Development of a burst wave lithotripsy system for noninvasive fragmentation of ureteroliths in pet cats. BMC Vet Res. 2023 Sep 2;19(1):141. doi: 10.1186/s12917-023-03705-1. PMID: 37660015

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Ureterocele

mmayes — Wed, 08 Dec 2021 14:14:00 +0000

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with a ureterocele. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.

How it Works
Where the beams converge, focused ultrasound produces cavitation (histotripsy) to achieve tissue fractionation (punctures) in a tissue model of a preclinical ureterocele wall. More research is needed to establish the safety and efficacy of this procedure before proceeding to clinical trials.

Advantages
The primary options for treatment of a ureterocele include medication and invasive surgery.

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary.

Clinical Trials

At the present time, there are no clinical trials recruiting patients for treatment of ureterocele.

Regulatory Approval and Reimbursement

Focused ultrasound treatment for ureterocele is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Maxwell AD, Hsi RS, Bailey MR, Casale P, Lendvay TS. Noninvasive ureterocele puncture using pulsed focused ultrasound: an in vitro study. J Endourol. 2014 Mar;28(3):342-6.

Click here for additional references from PubMed.

Chyluria

mmayes — Wed, 08 Dec 2021 14:13:00 +0000

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with chyluria. This novel technology focuses beams of ultrasonic energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.

How it Works
Where the beams converge, focused ultrasound produces precise ablation (thermal destruction of tissue) enabling the aberrant lymphatic urinary tract connections to be treated without surgery.

Advantages
The primary options for treatment of chyluria include embolization or invasive surgery.

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary.

Clinical Trials

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatments for chyluria.

Find a Treatment Site

Search for a treatment center or clinical trial near you.

Regulatory Approval and Reimbursement

Focused ultrasound treatment for chyluria is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Xiao J, Sun T, Zhang S, et al. HIFU, a noninvasive and effective treatment for chyluria: 15 years of experience. Surg Endosc. December 2017. doi:10.1007/s00464-017-6017-8.

Click here for additional references from PubMed.