Electrical stimulation (e.g. sacral nerve modulation) is an effective treatment modality for faecal incontinence (FI). Dorsal genital nerve (DGN) stimulation has in experimental studies demonstrated efficacy too. The UCon neurostimulator is a novel device for clinical purpose, to provide electrical stimulation of the DGN, with an adhesive silicone electrode placed above the clitoris or at the root of penis. This study aimed to test the UCon neurostimulator in patients diagnosed with FI or strong faecal urgency (FU) in a home setting. We hypothesized that stimulation of DGN would be feasible and safe without serious adverse device events, reduce the frequency of FI episodes, strong FU episodes and reduce bowel related symptoms.

The study was a multicentre, prospective, feasibility study. Inclusion criteria were patients ≥18 years reporting FI ≥1 episode pr. week or strong FU ≥3 episode pr. week and with a St. Mark’s Incontinence Score (SMIS) ≥9. At baseline, patients performed a 14-days bowel habit diary documenting FI episodes, strong FU episodes and the total number of bowel movements. Intervention period with UCon stimulation was four weeks at a home setting, and could either be time-limited (30 minutes/day) or on demand stimulation (60 seconds). On demand modality gave the opportunity to initiate stimulation immediately when strong FU occurred and repeat the stimulation unlimited (Figure 1). Patients were given one of the two stimulation modalities based on their preference and expected effect. Efficacy was measured by using a 14-days bowel habit diary (the last two weeks of treatment), SMIS score, Quality of Life (QoL) measures including impact on daily life (VAS-DL) (0 no impact/10 high impact) and a Rockwood score. Data analysis on the completed (n=26), was performed on raw data and paired t-test was done for comparison.

We included 40 patients (39 women) median age 62 interquartile range (Q1-Q3: 54-69) and 26 completed the intervention period. Time-limited stimulation was done by 23 patients and three received on-demand stimulation (Figure 2). No serious adverse device events were reported. Number of FI episodes for n=20 (with FI ≥1 episode pr. week) were significantly reduced from 5 (Q1-Q3: 3.5-9) to 2 (Q1-Q3: 0.5-4) (P:0.004) per two weeks and 15 (75 %) had ≥50 % reduction in FI episodes per two weeks. 
Number of strong FU episodes for n=15 (with strong FU ≥3 episodes pr. week) were significantly reduced from 11 (Q1-Q3: 9-18) to 6 (Q1-Q3: 3-13) (P: <0.001) per two weeks and 6 (40 %) had ≥50 % reduction in strong FU episodes per two weeks. 
SMIS on n=26 was significantly reduced from 16.0 (Q1-Q3: 13-18) to 11.5 (Q1-Q3: 9-15) (P: <0.001). Total number of bowel movements on n=26 was significantly reduced from 31.5 (Q1-Q3: 24-46) to 25 (Q1-Q3: 20-32) (P:0.001). VAS-DL on n=26 improved from 7.0 (Q1-Q3: 7-8) to 5.0 (Q1-Q3: 3-7) (P: <0.001). Rockwood Lifestyle score improved from 3.05 (Q1-Q3: 2.4-3.5) to 3.4 (Q1-Q3: 3-3.8) (P: <0.001), Rockwood Coping/behavior score improved from 1.59 (Q1-Q3: (1.23-1.88)) to 2.41 (Q1-Q3: (1.5-2.67)) (P: <0.001), Rockwood Depression score improved from 2.9 (Q1-Q3: (2.46-3.40) to 3.46 (Q1-Q3: (2.89-3.57) (P: 0.002) and Rockwood Embarrassment score improved from 2.33 (Q1-Q3: (2-2.67) to 3 (Q1-Q3: (2.33-3.33) (P: 0.000).

UCon neurostimulator significantly reduced number of FI episodes, strong FU episodes per two weeks and SMIS. Only three out of 15 with strong FU received on-demand stimulation. The effect of each stimulation modality in the present study cannot be evaluated due to the assignment of the stimulation modes based on their symptoms or preferences.

The UCon neurostimulator is feasible and safe. The clinical results showed a reduction in both FI episodes and strong FU episodes, further a reduction in SMIS and an increase in FI specific QoL measures. The UCon neurostimulator indicates promising potential in the treatment of FI and FU.