PosStim™: Advancing Toward Direct Pelvic Neuromodulation

A Preclinical Milestone in the Development of Targeted Neurostimulation for Pelvic Disorders

Introduction

Neuromodulation is increasingly recognized as a key therapeutic modality in the management of pelvic disorders, including overactive bladder, pelvic pain, and sexual dysfunction.

While existing approaches have primarily focused on indirect modulation via peripheral or sacral pathways, growing clinical experience suggests that direct stimulation of pelvic nerves may offer a more anatomically and physiologically targeted strategy.

NeuroGyn AG has been actively developing such an approach over the past years. This work has now reached an important milestone with the completion of the first fully integrated implantable system: PosStim™.

From Clinical Experience to Technological Development

The development of PosStim™ is grounded in more than two decades of clinical experience in pelvic nerve stimulation.

Initial approaches relied on:

  • external surface electrodes 
  • temporary stimulation protocols 
  • limited reproducibility in daily practice 

Despite these limitations, these early methods provided consistent clinical observations supporting the relevance of direct pelvic nerve stimulation in modulating bladder and pelvic function.

The next logical step was therefore the transition from temporary, external stimulation to a chronic, implantable solution.

A Minimally Invasive and Reproducible Approach

PosStim™ has been designed with a clear objective: to enable direct pelvic neuromodulation through a simple and standardized implantation technique.

The system allows:

  • implantation under local anesthesia 
  • a small suprapubic incision (~1 cm) 
  • percutaneous electrode placement using established surgical principles 
  • short procedure times 
  • reproducibility across operators 

This approach aims to make pelvic neuromodulation accessible beyond highly specialized centers, including within routine gynecological practice.

System Design and Practical Considerations

A key aspect of PosStim™ is its integrated system architecture.

The device is designed to:

  • be fully assembled and tested prior to implantation 
  • allow intraoperative verification by the surgeon 
  • function independently from intraoperative technical support 
  • enable patient-controlled use within predefined stimulation programs 

In addition, the system is conceived to:

  • minimize operating room time 
  • reduce logistical constraints 
  • facilitate outpatient workflows 

These considerations are essential for future scalability and adoption.

Current Status: Transition to Preclinical Phase

Following the completion of system development and design validation, PosStim™ is now entering the preclinical phase, including safety evaluation and preparation for first-in-human studies.

This step represents a critical transition from:

  • concept and development
    to 
  • biological validation and regulatory progression 

Further data will be required to assess:

  • safety profile 
  • stimulation parameters 
  • clinical efficacy across indications 

A Step Toward Targeted Pelvic Neuromodulation

PosStim™ is not intended to replace existing neuromodulation strategies, but to complement and expand the therapeutic landscape.

Its development reflects a broader evolution in the field:

from indirect neuromodulation toward anatomically targeted pelvic nerve stimulation.

Whether this approach will translate into improved clinical outcomes remains to be demonstrated in upcoming studies.

However, its physiological rationale and clinical foundation suggest that it may represent an important step toward a more precise and integrated management of pelvic disorders.

Conclusion

The development of PosStim™ marks a significant milestone in the effort to bring direct pelvic neuromodulation into clinical practice.

Now entering the preclinical phase, the focus will shift toward rigorous evaluation and validation.

The future of neuromodulation in pelvic medicine will depend not only on technological innovation, but also on the ability to align therapy with the underlying neuroanatomy and physiology of pelvic function.