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"Our outcomes showed 71% of patients achieved dry or near dry results in 6 to 12 weeks," says Nissrine Nakib, MD.

The post-market RESTORE trial plans to enroll 150 patients with urge urinary incontinence across 20 clinical trial sites in the US.

Interim data from the study showed that at 6 months following implantation, 80% (4 of 5) of evaluable women with mixed UI experienced a complete resolution of incontinence episodes.

Overall, the patient met the study’s primary outcome measures of successful device activation and the rate of explants and revisions at 6 months.

The real-world study plans to enroll 500 patients who are utilizing the Leva Pelvic Health System, a non-invasive medical device to help women train and strengthen pelvic floor muscles.

Clarius Bladder AI ultrasound software may have significant utility in acute care settings, urology clinics, and nursing homes.

The coverage policy went into effect on December 28, 2023.

"We found that less than 5% of people with incontinence had received a surgical intervention for their incontinence within a year of the survey," says Giulia I. Lane, MD, MS.

All of those enrolled in the study have been implanted for at least 7 months, with the longest implantation at 15 months.

According to Neuspera, results from phase 2 of the SANS-UUI trial are expected to support an application for FDA approval of the device in patients with OAB-related UUI.

"This work and previous work supports the idea that EBV not only causes MS, but also continues to affect disease progression," write the authors.

The phase 2a open-label dose ascending study to assess the safety, tolerability, and efficacy of VMB-100 in female patients with moderate SUI is expected to begin in the first half of 2024.

These findings may help guide decision-making in the initial testing phase of the [sacral neuromodulation] device prior to permanent implant or explant, according to Bradley Gill, MD, of the Cleveland Clinic.

"I treat all aspects of male and female incontinence, whether this be artificial urinary sphincter, the male sling, female sling, bladder Botox, or sacral neuromodulation," said Jas Singh, MD, FRCS.

In total, the prospective SOPHIA study enrolled 6 men with stress urinary incontinence who have reduced outlet resistance due to intrinsic sphincter deficiency.

The phase 3 URO-901-3005 study met its 2 co-primary end points with vibegron demonstrating a reduction in micturition episodes and urgency episodes from baseline to 12 weeks.

The FDA's decision was based on results from the OASIS trial, in which the Revi tibial neurostimulator device demonstrated significant efficacy for treating urge urinary incontinence in women.

"Despite prevalent OAB symptoms, only 6% of all LUTS prescriptions in men were for OAB medications," says Sarah Neu, MD, MSd, FRCSC.

The UroActive device is currently being studied in the SOPHIA study, which published initial results earlier this year.

UroMonitor was developed in response to conventional urodynamics, which have several limitations.

"It's certainly a bigger problem with advancing age in the geriatric population, and it can be a tremendous source of cost for patients who have these issues," says Gina M. Rooker, MD.

The study assessed 120 women with overactive bladder for associations between anxiety and somatic symptoms, quality of life, quantitative sensory testing measures, and psychological stress symptoms.

Optimal bedtime was determined using the bedtime and mid-awake time for each patient, which was gathered from an Actiwatch Spectrum device.

The tool uses clinical covariates to predict changes in storage, voiding, and nocturia LUTS for patients receiving placebo, dutasteride, tamsulosin, or DUT/TAM combination therapy.

Vivally System is a neuromodulation system that uses a closed-loop control algorithm and electromyography to personalize treatment for each patient.

"This is something [that is] a lot easier for the patient, it's a lot less costly to the health care system to stay out of the operating room, and it's a lot quicker for me," says Howard B. Goldman, MD.

"The sad thing is that with something like OAB, we already have so many barriers to getting patients in to initiate care in the first place," says A. Lenore Ackerman, MD, PhD.

"The evidence is starting to show us that although efficacy in terms of managing OAB symptoms may be equal or similar across studies for these 2 classes of medications, safety and tolerability are very different," says A. Lenore Ackerman, MD, PhD.

The safety and efficacy of the Vivally System were established in the FREEOAB study, a prospective multi-center clinical trial that included 96 patients with overactive bladder.

“We recommend mirabegron monotherapy as an alternative medical treatment choice for the management of OAB,” the authors wrote.