A novel device that delivers electrical stimulation to the dorsal genital nerve (DGN) in a home setting is safe and demonstrates potential in the treatment of faecal incontinence and faecal urgency.
Called the UCon neurostimulation, the device consists of two specially designed patch electrodes, one placed at the genital and the other at the inner thigh or lower abdomen. The stimulation can be individualized for each patient based on baseline data, patient preferences, and expected treatment effect, according to lead investigator Dr Louise Schmidt Grau from Aarhus University Hospital, Aarhus, Denmark.
“By providing a more accessible and less invasive form of neuromodulation, the UCon neurostimulator may overcome some limitations of current therapies,” Grau said.
Safety, incontinence/urge frequency
In a feasibility study, no serious adverse device-related events occurred during the 4-week stimulation intervention with the UCon. A median of 1.5 adverse or device-related events per patient were documented, but Grau noted that these events were “mild and transient.” [Neurogastroenterol Motil 2025;doi:10.1111/nmo.70225]
After 4 weeks, the frequency of faecal incontinence episodes significantly decreased, from a median of 5 at baseline to 2 (p=0.005). Almost a quarter of patients (74 percent) with ≥1 weekly faecal incontinence episode at baseline achieved a ≥50-percent reduction in the frequency of episodes, and 26 percent of patients became fully continent.
Similarly, the frequency of strong faecal urgency episodes was significantly reduced from a median of 11 at baseline to 5.5 after the 4-week intervention (p<0.001). Forty-three percent of patients with ≥3 weekly episodes of strong faecal urgency at baseline achieved ≥50-percent reduction in the frequency of episodes. The frequency of moderate urgency episodes remained unchanged, while that of mild episodes increased numerically from a median of 5 at baseline to 10 (p=0.315). The total number of bowel movements decreased from a median of 31 to 24 (p<0.001).
Symptom burden
The St Mark’s Incontinence Score dropped from a median of 16 at baseline to 11.5 after 4 weeks (p<0.001), indicating reduced incontinence severity, Grau said.
Based on the Numeric Rating Scale (NRS) for the impact of faecal incontinence on daily life, the patients perceived a reduced burden following the 4-week intervention with UCon. The median NRS score decreased from a median of 7 to 5 (p<0.001).
Significant improvements were also observed in condition-specific bowel-related quality of life. Scores in all subscales of the Fecal Incontinence Quality of Life questionnaire increased: from 3.1 to 3.4 for lifestyle (p<0.001), from 1.6 to 2.4 for coping/behaviour (p<0.001), from 2.9 to 3.5 for depression (p=0.002), and from 2.3 to 3 for embarrassment (p<0.001).
“However, it remains unclear whether this improvement [in symptom burden] reflects functional recovery,” Grau said.
“Perceptions of quality of life vary among individuals, as patients report the effects of bowel function differently; some may tolerate symptoms better than others. Consequently, it can be challenging to directly link significant results with clinical efficacy. Not all patients achieved full continence, which might result in ongoing limitations in daily activities and concerns about incontinence episodes,” she explained.
Study details
The study included 40 adults (median age 62 years, 97.5 percent female) with faecal incontinence ≥1/week and/or strong faecal urgency ≥3/week, and a St Mark’s Incontinence Score of ≥9. A total of 26 participants completed the study.
DGN stimulation with UCon was self-administered at home daily for 4 weeks in either a time-limited (30 min/day at any given time) or urge/on-demand (60 s upon every urge experienced throughout the day) modality.
“This work highlights the potential of DGN stimulation as a less-invasive therapeutic option for faecal incontinence and faecal urgency using an easy-to-use wearable neurostimulator,” Grau said in a social media post.
However, Grau acknowledged that the optimal duration, stimulation mode, and risk of symptom recurrence for UCon have yet to be established. She also shared that they are currently evaluating a percutaneous electrode for the device to address the device-related adverse events associated with the genital patch electrode and that a randomized controlled trial is ongoing to define the clinical value of this novel DGN stimulation approach.