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Dorsal Genital Nerve Stimulation in Patients With Fecal Incontinence and Fecal Urgency: A Feasibility Study With the
Louise Schmidt Grau1,2, Peter Christensen1,2, Niels Qvist3
1Department of Surgery, Pelvic Floor Unit, Aarhus University Hospital, Aarhus, Denmark.
Background:
The UCon neurostimulator is a novel device providing dorsal genital nerve (DGN) stimulation for treating fecal incontinence (FI)/fecal urgency (FU). The primary aim was to explore its safety and secondarily its performance, hypothesizing that DGN stimulation would be feasible and safe, while reducing FI/FU.
Method:
This was a prospective two-center feasibility study conducted in Denmark. Adults ≥ 18 years, with FI ≥ 1/week, and/or strong FU ≥ 3/week, and a St. Mark's Incontinence Score ≥ 9 were eligible. DGN stimulation was self-administered at home daily for 4 weeks in either a time-limited (30 min/day) or urge/on-demand (60 s upon urgency) modality. Safety was assessed through patient-reported adverse and device-related events. Efficacy was evaluated by comparing baseline data with the last 14 days of the intervention using symptom diaries, the St. Mark's Incontinence Score, and bowel-related quality-of-life measures.
Results:
Forty patients consented (39 women), median age 62 years (Q1-Q3: 54-69), and 26 patients completed the study. An adverse and device-related median of 1.5 events per patient was reported, but these were mild and transient. Among patients completing the 4-week intervention, 74% (n = 19) with FI and 43% (n = 14) with strong FU achieved ≥ 50% symptom reduction (p = 0.005 and p ≤ 0.001, respectively). St. Mark's Incontinence Score (n = 26) reduced significantly from 16.0 (13-18) to 11.5 (9-15) (p ≤ 0.001).
Conclusion:
Using the UCon neurostimulator in a home setting is safe and feasible. A 4-week stimulation period demonstrated significant positive results in treating FI and FU.
Clinical Trials Registration:
The conducted research was preregistered at ClinicalTrials.gov with the following link: (https://ClinicalTrials.gov/study/NCT05368246?cond=UCon&rank=5).
