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 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
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.