During the recent Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) meeting in Rancho Mirage, California, a panel of experts, moderated by Dr Howard Goldman, introduced a range of technological advances that have the potential to revolutionize our management of various urologic conditions.

Electromechanical Artificial Urinary Sphincter

The Boston Scientific AMS 800 artificial urinary sphincter is the gold standard for postprostatctomy urinary incontinence. Dr Benoit Peyrnonnet explored the possibility of an electromechanical artificial urinary sphincter that would be safe, ergonomic, adjustable, and comfortable for patients.

He introduced the UroActive—an electromechanical, 2-piece device consisting of an implantable control unit (containing the pump, reservoir, pressure sensor, and battery) and an occlusive cuff. The UroActive device is remote-controlled by the patient and operates at 2 pressure settings for a high baseline elevated pressure and a lower resting pressure at night to preserve urethral tissue. A UroTimer safety feature also releases the cuff if it has not been released for a certain time period.

Preliminary results of the SOPHIA trial were also discussed. This was a prospective, open-label, multicenter, single-arm study that included 6 patients who underwent implantation of the UroActive. The primary clinical outcomes demonstrated no explanation or revision at 6 months post activation. Median 24-hour pad weight test demonstrated 87% reduction at 1-year post activation. Patient-reported quality of life surveys also demonstrated significant improvement 1-year post activation. The UroActive has yet to undergo Food and Drug Administration (FDA) approval. Currently a multicenter clinical trial and a clinical trial in women are underway.

Implantable Tibial Nerve Stimulation

Dr Kenneth Peters then presented an overview of the burgeoning field of implantable tibial nerve stimulation devices (Figure 1). Current third-line therapies for overactive bladder include intravesical onabotulinum toxin, posterior tibial nerve stimulation, and sacral neuromodulation. Limitations of these therapies include necessity of repeat interventions, poor adherence, or need for the operating room, respectively.

Figure 1. Dr Kenneth Peters presents on the current field of overactive bladder management.

Implantable tibial nerve devices offer an alternative to posterior tibial nerve therapy that can overcome these limitations. These devices provide stimulation to the posterior tibial nerve that carries afferent signaling to the central nervous system. They are implanted either above or below the fascia, and can be placed under local anesthetic.

Current devices include eCoin, BlueWind Revi, Coloplast Intibia, and Medtronic Titan. eCoin is an FDA-approved device that is inserted above the fascia and contains an internal power source. BlueWind Revi also has FDA approval and is placed below the fascia with a wearable external power source. The other 2 devices pending FDA approval include the Medtronic Titan, implanted above the fascia with an internal power source, and the Coloplast Intibia, with lead placed below fascia and implantable pulse generatorabove the fascia. Currently, there are no head-to-head trials comparing these devices. Future studies will need to assess the effect of above or below fascia placement, long-term efficacy, complications, and comparison to current therapies.

Aquablation

Aquablation for benign prostatic hyperplasia (BPH) utilizes real-time ultrasound mapping of the prostate and water-jet ablation of the prostate tissue. Benefits include size- and shape-independent resection, improved ergonomics, and reduced retrograde ejaculation.

Dr Kevin Zom shared his experience with Aquablation and reviewed current trials. The WATER 1 study was a double-blind, randomized control trial comparing Aquablation to transurethral resection of the prostate. This demonstrated noninferiority in symptom improvement and lower rate of anejaculation.¹ The WATER 2 trial was a multicenter prospective study that included men with moderate to severe BPH.² Mean operative time was 37 minutes with total length of stay 1.6 days. The Clavien-Dindo grade 2 or higher event rate was 29.7% at 1 month. Future trials will potentially compare Aquablation to holmium laser enucleation of the prostate for BPH and to radical prostatectomy for prostate cancer

UTI Vaccines

Dr Lenore Ackerman presented a familiar scenario of a female patient with recurrent UTIs (rUTIs; Figure 2). The etiology of rUTIs is unclear but may stem from a disrupted microbiome resulting in chronic, systemic inflammation of the bladder.

Figure 2. Dr Lenore Ackerman discusses UTI vaccines.

MV140 (Uromune) is a polyvalent bacterial vaccine containing inactivated combination of Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, and Proteus vulgaris. This is thought to trigger immune response through antibody production and T-cell activation. A recent review of UTI vaccines demonstrated significantly decreased risk of UTI compared with placebo.³

When compared with antibiotic prophylaxis, UTI vaccines resulted in significantly higher percentage of UTI-free patients after 9 and 12 months. No significant adverse events were observed. Other preliminary studies have demonstrated good long-term efficacy and symptomatic improvement. UTI vaccines offer a promising new management for rUTI that does not alter the microbiome, enhances native immune surveillance, and reduces side effects of episodic antibiotic usage.

ProACT: Adjustable Continence Therapy for Male Stress Urinary Incontinence

Dr Bahaa Malaeb introduced the ProACT—an adjustable continence device for men with stress urinary incontinence. The device contains 2 silicone balloons that are attached to a titanium port. The balloons are implanted with a trocar at the bladder neck through a perineal incision. The ports are placed in the scrotum and are used to postoperatively adjust balloon volume. These can be placed in the operating room under fluoroscopic guidance or with transrectal ultrasound and local anesthetic.

Potential advantages of the ProACT include minimally invasive placement, customization of balloon volume, passive mechanism of action, tissue preservation, and use in a variety of continence levels. Dr Malaeb presented preliminary results from his institution. An earlier cohort had higher rates of prior radiation, bladder neck contracture, and prior incontinence surgeries. A later subset had a lower rate of radiation and incontinence surgeries, and no history of bladder neck contracture. The latter group had improved strictly dry rates compared with the earlier group. Postoperative complications included urinary retention, erosions, device migration, and device leakage. Factors associated with more than 50% improvement of leakage were younger age, no prior history of radiation, and no prior history of bladder neck contracture. Overall, they reported 50% significant improvement in urinary incontinence.

He concluded patient selection is a key factor in success for the ProACT. Future studies should compare different operative techniques to determine optimal balloon placement, patient selection criteria, and predictors.

Conflict of Interest Disclosures: Dr Goldman is a consultant for AbbVie and Medtronic, and Data and Safety Monitoring Board Chair for BlueWind.

1. Gilling P, Barber N, Bidair M, et al. WATER: a double-blind, randomized, controlled trial of Aquablation® vs transurethral resection of the prostate in benign prostatic hyperplasia. J Urol. 2018;199(5):1252-1261. doi:10.1016/j.juro.2017.12.065
2. Desai M, Bidair M, Bhojani N, et al. WATER II (80-150 mL) procedural outcomes. BJU Int. 2019;123(1):106-112. doi:10.1111/bju.14360
3. Mak Q, Greig J, Dasgupta P, Malde S, Raison N. Bacterial vaccines for the management of recurrent urinary tract infections: a systematic review and meta-analysis. Eur Urol Focus. 2024;10(5):761-769. doi:10.1016/j.euf.2024.04.002

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