Dorsal genital nerve stimulation with the novel UCon neurostimulator in patients with faecal incontinence and overactive bladder

Aim

Explore the feasibility, safety, and efficacy of the novel UCon neurostimulator providing dorsal genital nerve stimulation in patients diagnosed with faecal incontinence/urgency and overactive bladder.

Study design

STUDY 1) Prospective clinical, feasibility and safety study - patch electrode

STUDY 2) Prospective, clinical feasibility and safety study - bar electrode

STUDY 3) Randomized controlled trial (RCT) - dorsal genital nerve stimulation vs sham stimulation 

About the project

Faecal incontinence (FI), faecal urgency (FU) and overactive bladder (OAB) are conditions that profoundly affect an individual's quality of life, often leading to social withdrawal, emotional distress, and decreased participation in daily activities. When conservative treatments fail to alleviate symptoms, alternative therapeutic approaches become essential. Electrical stimulation has emerged as a potential solution, with sacral nerve modulation (SNM) being the most widely used method. Recent experimental studies indicate that dorsal genital nerve (DGN) stimulation can significantly alleviate symptoms of FI and OAB.

The UCon neurostimulator is a novel, minimally invasive device designed to provide electrical stimulation for the DGN. The control unit connects to patch electrodes via a lead and allows for patient-adjusted amplitude, facilitating the optimisation of treatment based on individual needs. Two stimulation modalities are being evaluated for home use: 30-minute time-limited stimulation sessions and 60-second urge/on-demand stimulation sessions for each urgency experienced.

As part of ongoing development, the external genital patch electrode is refined into a permanent bar electrode intended for implantation at the clitoral hood. This innovation aims to enhance stability, precision, and long-term efficacy in delivering DGN stimulation for clinical applications.
This study's insights may help develop clinical guidelines and broaden therapeutic options for patients with FI, FU, and OAB.

Publications:

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Research area:

Pelvic Floor Unit

Project Investigator (PI)

Project participants:

  • Jakob Jakobsen, MD, DMSc, Associate Professor, Consultant Colorectal Surgeon, Department of Surgery, Aarhus University Hospital
  • Peter Christensen, MD, DMSc, Professor, Consultant Colorectal Surgeon, Department of Surgery, Aarhus University Hospital
  • Niels Klarskov, MD, DMSc, Professor, Obstetrics and Gynaecology, Herlev University Hospital
  • Mark Ellebaek, MD, DMSc, Professor, Consultant Surgeon, Department of Surgery, Odense University Hospital
  • Niels Qvist, MD, DMSc, Professor, Research Unit for Surgery, Odense University Hospital
  • Nico Rijkhoff, PhD, Research Unit for Surgery, Odense University Hospital
  • InnoCon Medical

Funding:

  • Innovation Fund Denmark - Grand Solutions (0176-00014B)