A single-use anal insert device appears to be a safe and effective option for patients with faecal incontinence (FI) refractory to medical and behavioural therapy, having been shown to reduce the frequency of episodes in a trial.
Called StaySure, the device is soft and flexible, filled with mineral oil and petrolatum and coated with a medical-grade petroleum jelly, for self-insertion into the anus.
“The liquid-filled shaft fills the anal canal, allowing sphincter pressure to maintain the seal, while an external retainer flare prevents migration,” explained lead researcher Dr Adil Bharucha from Mayo Clinic, Rochester, Minnesota, US, and colleagues.
“Because the device physically occludes the anal canal, its use may be particularly beneficial in patients with passive FI and/or a patulous anal canal that permits stool leakage, provided the canal is not so patulous that the device is expelled,” they added.
In the trial, Bharucha and colleagues tested the device in participants with FI for ≥6 months and ≥4 moderate or large FI episodes during a 4-week baseline. Participants had to enter a 2–4-week fitting/run-in period to test two different sizes of the insert (10 or 13 mm) and select their preferred size before starting with the 4-week treatment period.
Over 4 weeks of treatment, the primary outcome of a ≥50-percent reduction in FI frequency was achieved in 76.3 percent of participants (p<0.001), and a ≥75-percent reduction occurred in 54 percent (p=0.302). [Aliment Pharmacol Ther 2026;doi:10.1111/apt.70831]
The mean number of days with FI decreased from 13.2 at baseline to 6.3 at week 4, and the weekly FI frequency declined by 69 percent, from 5.4 to 2.1 (p<0.001). The number of weekly urge FI episodes decreased from 2 to 0.93 (p<0.001), and the mean proportion of complete bowel movements increased by an absolute value of 6.1 percent over 4 weeks (p=0.008).
The symptom relief score decreased significantly during the treatment period, from 3.5 at baseline to 1.9 at week 4 (p<0.001). The same was observed for the overall score on the Faecal Incontinence Quality of Life (FI-QoL) scale, decreasing from a mean of 1.9 to 2.3 (p<0.001). Significant improvements were also observed in anxiety (p=0.01) and depression (p=0.025).
“The treatment-associated improvement in several outcomes met or exceeded the minimal clinically important difference thresholds, confirming clear benefit,” Bharucha and colleagues noted.
There were no treatment-related serious adverse events (AEs) documented. Only four participants (5.6 percent) reported AEs. One participant reported a single episode of device over-insertion into the rectum, and one participant each had perianal pain and bleeding related to a flare of lichen sclerosis, abdominal cramps, and perianal soreness.
In terms of satisfaction, most participants were satisfied with the device. Satisfaction rates were 83 percent for dimensions of the device, 94 percent for weight, 96 percent for ease of adjustment, 87 percent for safety and security, 96 percent for durability, 94 percent for ease of use, 85 percent for comfort, and 66 percent for effectiveness. Of the participants, 89.3 percent, 73 percent, and 62.5 percent ranked effectiveness, comfort, and ease of use, respectively, as the most important factor that influenced their satisfaction with the StaySure device.
“Taken together, these findings support the use of the StaySure anal insert in patients with FI who are refractory to medical and behavioural therapy,” Bharucha and colleagues said. “Although participants used the device daily, some patients prefer intermittent use—for example, during travel, social events, or when toilet access is uncertain. Patients who find the device comfortable, effective, and easy to use may elect to continue long-term use. “
A total of 59 participants were included in the study (mean age 66.9 years, 93 percent female, mean BMI 26.1 kg/m2). Most participants (76 percent) had one or more organic conditions associated with diarrhoea and/or anorectal sensorimotor dysfunctions. Nearly half of the cohort (46 percent) had actual or potential obstetric trauma, including forceps-assisted deliveries or possible anal sphincter injury, as reported in medical records or by the patient. Prior procedures for FI included sacral nerve stimulation (n=11), anal sphincteroplasty (n=4), and anal injection of dextranomer (n=2).