Top 10 Urology Times women’s health articles of 2025

Urology Times’® top female urology stories of 2025 captured a year of meaningful progress across the specialty, from emerging drug and cell-based therapies to pivotal guideline and regulatory developments. Among the most notable advances were the FDA’s decision to remove long-standing warning labels on hormone replacement therapy (HRT), a landmark change that resonated across urology and women’s health, as well as major advances in recurrent urinary tract infection (UTI) management, including updated clinical guidelines and FDA approval of the oral antibiotic gepotidacin (Blujepa).

Study progresses of sunobinop for interstitial cystitis/bladder pain syndrome

In March 2025, Imbrium Therapeutics announced that the final patient visit had been conducted in a phase 1b study (NCT06285214) evaluating the investigational oral agent sunobinop (V117957) in patients with interstitial cystitis/bladder pain syndrome (IC/BPS).¹ The study enrolled 47 female patients who were randomly assigned to receive 1 mg sunobinop taken orally at bedtime or to a matched placebo tablet.

Addressing an unmet need: CELLEBRATE trial explores cell-based therapy for recurrent SUI

The methodology of the phase 3 CELLEBRATE trial was shared at the American Urological Association (AUA) 2025 Annual Meeting in Las Vegas, Nevada.² Overall, the trial is assessing the safety and efficacy of autologous muscle-derived cells (iltamiocel) vs placebo for the treatment of adult women with post-surgical stress urinary incontinence (SUI). In an interview with Urology Times, study investigator Melissa R. Kaufman, MD, PhD, FACS, broke down the design and potential implications of this study for clinical practice.

Vaginal prolapse repair and sling surgery significantly reduce UUI

In an interview with Urology Times, Christina M. Mezes, DO and Catherine A. Matthews MD, discussed the background, notable findings, and implications of the Urogynecology study “Effect of Vaginal Prolapse Repair and Midurethral Sling on Urgency Incontinence Symptoms.”³

AUA releases amendment to recurrent uncomplicated UTIs in women guideline

In September 2025, the AUA, in collaboration with the Canadian Urological Association and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), released an amendment to the guideline on recurrent uncomplicated UTIs in women.⁴ The amendment includes an expansion of nonantibiotic options for UTI prophylaxis, emphasizes clinical judgement over microbial detection in ruling out UTI, and continues to recommend vaginal estrogen for perimenopausal and postmenopausal women with recurrent UTIs.

FDA removes warning labels on hormone replacement therapy

On November 10, 2025, the FDA took historic action by announcing plans to remove warning labels linking HRT for menopause with an increased risk of cardiovascular disease, breast cancer, and probable dementia.⁵ This announcement followed a panel discussion in July 2025 in which experts urged the FDA to update the warning labels on HRT, arguing that the risks of adverse effects may be overstated.

Sildenafil cream for female sexual arousal disorder available to prescribe in select states

Daré Bioscience announced that their proprietary topical arousal cream designed to enhance genital blood flow and arousal response in women, DARE to PLAY, can now be prescribed in select states.⁶ The company is making the sildenafil cream formulation available in the form of a Section 503B compounded product as they continue the process to seek FDA approval of the cream.

Phase 3 data of oral sulopenem for uUTIs published in NEJM Evidence

Data from the phase 3 REASSURE trial (NCT05584657) were published in NEJM Evidence, demonstrating that oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet; Orlynvah) was non-inferior to oral amoxicillin/clavulanate (Augmentin) in the treatment of adult women with uncomplicated UTIs.⁷ Oral sulopenem was approved by the FDA in October 2024 based in part on results from the REASSURE trial.

FDA approves gepotidacin for uncomplicated UTI

In March 2025, the FDA approved gepotidacin for the treatment of female adults (40 kg and over) and adolescents (aged 12 years and older; 40 kg and over) with uncomplicated UTIs caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.⁸ The approval is supported by results from the phase 3 EAGLE-2 (NCT04020341) and EAGLE-3 (NCT04187144) trials.

Erosion of ring pessary with bladder rupture and complete eversion: A report of successful single-stage transvaginal repair

In an editorial for Urology Times, E. Mackenzie Gibbs, MD, and Charles Lloyd Secrest, MD, discuss a rare case of ring pessary erosion that resulted in complete bladder rupture with eversion and grade 4 prolapse of bladder, ureters, cervix, and small bowel through the vaginal vault. The erosion was successfully repaired in a single stage entirely via transvaginal approach.

Pearls & Perspectives: Understanding and Improving Pelvic Health, with Diane Newman, DNP

In this episode of Pearls & Perspectives, host Amy Pearlman, MD, is joined by Diane K. Newman, DNP, a nationally recognized expert in pelvic health, to explore the often-overlooked yet vitally important topic of pelvic floor dysfunction. Together, they delve into the evolution—and stagnation—of conservative pelvic floor care in the US, the importance of early intervention, and the ways telehealth and technology can close the access gap in pelvic care.

REFERENCES

1. Imbrium Therapeutics achieves last patient last visit in clinical trial of potential treatment for interstitial cystitis/bladder pain syndrome. News release. Ibrium Therapeutics. March 11, 2025. Accessed December 31, 2025. https://www.imbriumthera.com/news/imbrium-therapeutics-achieves-last-patient-last-visit-in-clinical-trial-of-potential-treatment-for-interstitial-cystitis-bladder-syndrome/

2. Kaufman M, Canestrari E, Nisha P, Jankowski R. CELLEBRATE: A double-blind, randomized, controlled study assessing the efficacy and safety of the iltamiocel cell therapy in the treatment of women with persistent or recurrent stress urinary incontinence following surgical treatment. Presented at: 2025 American Urological Association Annual Meeting. Las Vegas, Nevada. April 25-29, 2025. https://www.auajournals.org/doi/10.1097/01.JU.0001110436.86964.27

3. Mezes CM, Russell GB, Gutman RE, et al. Effect of Vaginal Prolapse Repair and Midurethral Sling on Urgency Incontinence Symptoms. Urogynecology (Phila). 2025;31(3):250-257. doi:10.1097/SPV.0000000000001620

4. Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline (2025). American Urological Association. Accessed December 30, 2025. https://www.auanet.org/guidelines-and-quality/guidelines/recurrent-uti

5. HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. News release. US Food & Drug Administration. November 10, 2025. Accessed December 31, 2025. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy-0

6. DARE to PLAY sildenafil cream now available for pre-order by prescription: First evidence-based topical arousal cream for women begins commercial rollout in select states via 503B outsourcing facility. News release. Daré Bioscience, Inc. December 10, 2025. Accessed December 31, 2025. https://ir.darebioscience.com/news-releases/news-release-details/dare-playtm-sildenafil-cream-now-available-pre-order

7. Puttagunta S, Aronin SI, Gupta J, et al. Sulopenem versus amoxicillin/clavulanate for the treatment of uncomplicated urinary tract infection. NEJM Evid. 2025;4(7):EVIDoa2400414. doi:10.1056/EVIDoa2400414

8. Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older. News release. GSK. March 25, 2025. Accessed December 31, 2025. https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/