FDA updates in urology: December 2025

Welcome to Urology Times’® monthly FDA update! The year wrapped up with a flurry of regulatory approvals across prostate cancer, benign prostatic hyperplasia (BPH), and other benign conditions. Notable advances in December included clearance of the Hugo robotic system for urologic procedures as well as approvals for the ProVee and Zenflow Systems in BPH.

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FDA News in Urology from December 2025

1. FDA grants 510(k) clearance to Vanquish Water Vapor System for intermediate-risk prostate cancer

On December 2, 2025, Francis Medical announced FDA 510(k) clearance for the Vanquish Water Vapor System for prostate tissue ablation in patients with intermediate-risk localized prostate cancer.¹ This approval is based on 12-month data from the prospective VAPOR 2 trial (NCT05683691), in which treatment with the Vanquish System demonstrated high rates of MRI-confirmed disease ablation, no device-related serious adverse events, low rates of urinary and sexual dysfunction, and high patient satisfaction.

2. FDA grants clearance to Hugo robotic-assisted surgery system for urologic procedures

On December 3, 2025, Medtronic announced FDA clearance of the Hugo robotic-assisted surgery system for use in minimally invasive urologic procedures including prostatectomy, nephrectomy, and cystectomy.² This approval is based on results from the Expand URO IDE study (NCT05696444), which met its primary effectiveness and safety end points, demonstrating a 98.5% surgical success rate and low rates of grade 3 or higher Clavien-Dindo complications across procedures.

3. FDA approves ProVee System for benign prostatic hyperplasia

On December 9, 2025, ProVerum Limited announced FDA approval of the ProVee System, a prostatic urethral stent for the treatment of patients with BPH.³ The approval is based on results from the phase 3, randomized ProVIDE study (NCT05186740), in which patients who received the ProVee System demonstrated durable relief of lower urinary tract symptoms and improved urinary flow through 12 months.

4. FDA approves gepotidacin for uncomplicated urogenital gonorrhea

On December 11, 2025, GSK announced FDA expanded approval of gepotidacin (Blujepa) as an oral treatment for uncomplicated urogenital gonorrhea caused by susceptible Neisseria gonorrhoeae in patients aged 12 years and older weighing at least 45 kg with limited or no alternative options.⁴ This decision adds on gepotidacin’s previous indication for uncomplicated urinary tract infection. The approval is supported by results from the phase 3 EAGLE-1 trial (NCT04010539), in which gepotidacin demonstrated noninferiority to intramuscular ceftriaxone plus oral azithromycin in regard to the treatment success rates.

5. FDA approves first-line Zenflow system for the treatment of BPH

On December 11, 2025, Zenflow announced FDA approval of their Zenflow Spring Implant and Delivery System for the treatment of symptoms associated with benign prostatic hyperplasia (BPH).⁵ This approval is based on findings from the pivotal BREEZE study (NCT04987138), in which the ProVee System demonstrated a 37% improvement in International Prostate Symptom Score vs sham, as well as no device-related serious adverse events and high patient satisfaction.

6. FDA approves zoliflodacin for uncomplicated urogenital gonorrhea

On December 12, 2025, Innoviva Specialty Therapeutics announced FDA approval of zoliflodacin (Nuzolvence) as a single-dose oral treatment for uncomplicated urogenital gonorrhea in adults and pediatric patients aged 12 years and older weighing at least 77 lbs.⁶ This approval is based on results from a phase 3 randomized trial (NCT03959527) demonstrating noninferior microbiological cure rates with zoliflodacin compared with ceftriaxone plus azithromycin, including activity against drug-resistant Neisseria gonorrhoeae and a favorable safety profile.

7. FDA approves niraparib plus abiraterone acetate with prednisone for BRCA2+ mCSPC

On December 12, 2025, the FDA approved the combination of niraparib plus abiraterone acetate and prednisone (Akeega; AAP) for adult patients with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).⁷ The approval was backed by data from the phase 3 AMPLITUDE trial (NCT04497844), which demonstrated that adding niraparib to AAP significantly improved radiographic progression-free survival (rPFS) vs placebo and AAP, which the agency determined was “primarily attributed to the results seen in patients with BRCA2m.”

8. FDA approves flibanserin for hypoactive sexual desire disorder in postmenopausal women

On December 15, 2025, Sprout Pharmaceuticals announced FDA approval of an expanded indication for flibanserin 100 mg (Addyi) for the treatment of hypoactive sexual desire disorder in postmenopausal women younger than 65 years.⁸ This approval supports expanded access to the non-hormonal therapy, which was previously approved only for certain premenopausal women.

9. FDA grants 510(k) clearance to enhanced Revi System for urgency urinary incontinence

On December 16, 2025, BlueWind Medical announced FDA 510(k) clearance for an enhanced iteration of the Revi System, an implantable tibial neuromodulation device for urgency urinary incontinence (UUI).⁹ The safety and efficacy of the Revi System were demonstrated in the pivotal OASIS trial (NCT03596671), which showed durable symptom relief, high patient satisfaction, and a favorable safety profile with the system through 24 months.

10. FDA approves rucaparib for chemotherapy-naïve, BRCA-mutated mCRPC

On December 17, 2025, the FDA granted regular approval to rucaparib (Rubraca) for the treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) who have received prior androgen receptor-directed therapy. This approval is based on results from the phase 3 TRITON3 trial (NCT02975934), in which treatment with rucaparib led to a statistically significant improvement in rPFS compared with physician’s choice of treatment, with a safety profile consistent with prior studies.

REFERENCES

1. Francis Medical receives FDA 510(k) clearance for use of the Vanquish® Water Vapor System for prostate tissue ablation in patients with intermediate risk prostate cancer. News release. Francis Medical. December 2, 2025. Accessed January 2, 2025. https://www.francismedical.com/francis-medical-receives-fda-510k-clearance-for-use-of-the-vanquish-water-vapor-system-for-prostate-tissue-ablation-in-patients-with-intermediate-risk-prostate-cancer/

2. Medtronic announces FDA clearance of Hugo™ robotic-assisted surgery system for urologic surgical procedures. News release. Medtronic. December 3, 2025. Accessed January 2, 2025. https://news.medtronic.com/2025-12-03-Medtronic-announces-FDA-clearance-of-Hugo-TM-robotic-assisted-surgery-system-for-urologic-surgical-procedures

3. FDA approves the ProVee System - the first of a new generation of prostatic urethral stents for treatment of BPH. News release. ProVerum Limited. December 9, 2025. Accessed January 2, 2025. https://www.prnewswire.com/news-releases/fda-approves-the-provee-system--the-first-of-a-new-generation-of-prostatic-urethral-stents-for-treatment-of-bph-302637233.html

4. Blujepa (gepotidacin) approved by US FDA as oral option for treatment of uncomplicated urogenital gonorrhoea (uGC). GSK. December 11, 2025. Accessed January 2, 2025. https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-as-oral-option-for-treatment-of-uncomplicated-urogenital-gonorrhoea-ugc/

5. FDA approves the Zenflow Spring Implant and Delivery System for first-line interventional therapy of patients with benign prostatic hyperplasia (BPH). News release. Zenflow, Inc. December 11, 2025. Accessed January 2, 2025. https://www.globenewswire.com/news-release/2025/12/11/3204336/0/en/FDA-Approves-the-Zenflow-Spring-Implant-and-Delivery-System-for-First-Line-Interventional-Therapy-of-Patients-with-Benign-Prostatic-Hyperplasia-BPH.html

6. FDA approves two oral therapies to treat gonorrhea. News release. US Food & Drug Administration. December 12, 2025. Accessed January 2, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-two-oral-therapies-treat-gonorrhea

7. FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer. News release. US Food & Drug Administration. December 12, 2025. Accessed January 2, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration

8. Historic first in women's sexual health: FDA grants approval for Addyi® (flibanserin) in postmenopausal women. News release. Sprout Pharmaceuticals. December 15, 2025. Accessed January 2, 2025. https://www.prnewswire.com/news-releases/historic-first-in-womens-sexual-health-fda-grants-approval-for-addyi-flibanserin-in-postmenopausal-women-302642397.html

9. BlueWind Medical receives FDA 510(k) clearance for enhanced Revi® wearable supporting long-term treatment of urgency urinary incontinence. News release. BlueWind Medical. December 16, 2025. Accessed January 2, 2025. https://www.businesswire.com/news/home/20251216057440/en/BlueWind-Medical-Receives-FDA-510k-Clearance-for-Enhanced-Revi-Wearable-Supporting-Long-Term-Treatment-of-Urgency-Urinary-Incontinence

10. FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer. News release. US Food & Drug Administration. December 17, 2025. Accessed January 2, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer