Ease of Use of a Self-Fit Novel Device for Stress Urinary Incontinence

Objectives: To evaluate patient ease of use self-fitting for a novel intravaginal insert (Yōni.Fit®) compared to control, for stress urinary incontinence (SUI) in women.

Methods: This was a planned secondary endpoint with a descriptive analysis of a multicenter, randomized, sham-controlled, single-blind trial that enrolled women with SUI for >3 months with a positive cough stress test. Participants were randomized to either the novel Yōni.Fit® (Figure 1a and 1b) or control device (Figure 1c). After a brief training, participants self-fit from 6 different sizes and wore the insert daily for 12 hours. Device fit data was collected during the fitting phase (1 week), treatment phase (1 week) and open-label phase (1 month), during which control subjects could cross-over to the novel device. The primary outcome of this follow-up study was the percentage of days the subject felt the device was a good fit. Secondary outcomes included number of device sizes used during the fitting, treatment and open-label phases, unscheduled visits during the fitting phase for refitting, and patient-reported outcomes relating to device fit and comprehension. Subjects reported on device comprehension on a 7-point Likert scale. Data were analyzed as modified intention-to-treat and per protocol.

Results: From January 2020 to August 2022, 79 patients were screened for eligibility, 71 enrolled, 58 were randomized, 56 completed the treatment phase and 54 continued to the open label phase.
Demographic characteristics were similar between groups and all subjects were able to self-fit the devices. During the fitting phase, the majority of participants only trialed 2 or fewer sizes. Out of the 6 available sizes, the most frequently used sizes were 1,2 and 3 (Table 1).
In the treatment phase, the mean percentage of days in which the patients felt that the device size selected was a good fit was 96.6% in the novel device group and 98.9% in the control group. During the open-label phase, the mean percentage of days in which the novel device and control (that crossed over to the novel device) groups felt that the device size selected was a good fit was 90.3% and 87.4%, respectively. 90.3%, 93.5%, 93.6%, 96.8% and 93.5% of patients either strongly agreed or agreed that they were able to select device size, clean the device, insert the device, remove the device, and replace the device, respectively.

Conclusions: Approximately 90% of patients were able to self-select an appropriate device fit by trialing two or fewer devices. Good overall device fitting was seen during the treatment phase which persisted during the open label phase. Greater than 90% of patients were able to select device size, clean, insert, remove and replace the device. This demonstrates that the majority of patients are able to self fit and manage this novel device to treat SUI.