Wireless electrostimulation implants enable sphincter neuromuscular improvement toward mixed urinary incontinence

Area of Science:

• Biomedical Engineering
• Urology
• Neuromodulation

Background:

• Mixed urinary incontinence (MUI) presents a significant therapeutic challenge, with current treatments for urge and stress components being largely separate and often invasive.
• Existing neuromodulation for urge incontinence requires large, costly sacral implants, while stress incontinence management typically involves mechanical or surgical interventions.
• There is a need for advanced, minimally invasive solutions that can address both types of incontinence and restore sphincter function.

Purpose of the Study:

• To introduce and evaluate a novel wireless-powered implanted programmable electrostimulation of sphincters (WIPES) system.
• To assess the efficacy of WIPES in alleviating symptoms of both urge-urinary incontinence (UUI) and stress-urinary incontinence (SUI) in preclinical models.
• To investigate the impact of WIPES on peri-urethral neuromuscular remodeling and functional bladder-urethral outcomes.

Main Methods:

• Development of a soft, adhesive-patch-like implant integrating wireless power and tunable pulse generation for on-site urethral sphincter stimulation.
• Utilizing rat models with experimentally induced UUI and SUI to test the WIPES system under free-moving conditions.
• Quantifying alleviation rates in voiding frequency and volume, and assessing neuromuscular changes post-stimulation.

Main Results:

• The WIPES system demonstrated significant efficacy in both UUI and SUI models, achieving average alleviation rates of 90.62% for UUI and 97.92% for SUI in voiding parameters.
• The implant is characterized by its small size (<0.3 cm³) and light weight (<0.9 g), facilitating wireless power and programmable stimulation.
• Peri-urethral neuromuscular remodeling and improved bladder-urethral functional outcomes were observed, indicating successful restoration of coordinated continence control.

Conclusions:

• Wireless-powered implanted programmable electrostimulation of sphincters (WIPES) presents a promising, minimally invasive therapeutic strategy for mixed urinary incontinence.
• The system's miniaturized, wireless design and high efficacy in preclinical models suggest a potential for improved patient outcomes and reduced treatment burden.
• WIPES may offer a new paradigm for coordinated continence control by directly addressing sphincter dysfunction.