Abstract
Importance
There is a need for safe and efficacious nonsurgical options for women with stress urinary incontinence (SUI).
Objective
This study compared the safety and efficacy of Yōni.Fit, a novel intravaginal insert, with a sham device in treating women’s SUI.
Study Design
In a multicenter, single-blind, randomized, sham-controlled trial, women with SUI for ≥3 months with a positive cough stress test result were enrolled. Participants, using either Yōni.Fit or a sham device, self-fitted from 6 sizes wore the insert daily for 12 hours. The primary outcome was responder rate defined as a ≥ 50% reduction in pad weights. Secondary endpoints were change in pad weight, frequency of SUI episodes, Patient Global Impression of Change, Incontinence–Quality of Life Assessment, proportion of pad dry days, and Usefulness, Satisfaction, and Ease of Use Questionnaire.
Results
Fifty-six women completed the treatment phase. The responder rate based on pad weights was higher for Yōni.Fit (53.0% vs 23.3%, P = 0.013). Among Yōni.Fit participants, a greater proportion achieved SUI responder status compared to sham (96.3% vs 27.2%, P < 0.001). Participants using Yōni.Fit rated it higher in usefulness than sham (5.95 vs 4.13, P = 0.008). Although the adverse event rate was 54.8% in Yōni.Fit and 29.6% in sham, most adverse events were mild, with vaginal discomfort reported as most common.
Conclusions
Yōni.Fit significantly reduced pad weights and SUI events and was evaluated as more useful when compared to sham. Although adverse events were higher with Yōni.Fit, they were generally mild. Further research is necessary to evaluate long-term safety and efficacy.
WHY THIS MATTERS
The 2011 U.S. Food and Drug Administration (FDA) communication on mesh products for pelvic organ prolapse was not inclusive of midurethral slings for the treatment of stress urinary incontinence (SUI) and subsequent communications from the FDA re-enforced its proven safety and efficacy. However, the negative media attention surrounding mesh has created confusion and fear regarding slings. This has led to a decrease in the number of women electing to have sling surgery. Consequently, there is an increasing need for safe and efficacious nonsurgical options for women with SUI. Recently, there has been increased focus on vaginal inserts specifically designed for the treatment of SUI to help fill this void. However, the safety and efficacy of these inserts have mostly been studied in single-arm studies and with very limited follow-up. It is important to provide patients with a wide range of over the counter options to treat stress incontinence, including novel nonsurgical interventions with lower risk profiles. This study shows both the safety and efficacy of this novel device for treating SUI. This novel device will help add to the range of options patients have to treat stress-predominant urinary incontinence and specifically will increase options for self-administered interventions with lower risk profiles.
SIMPLY STATED
This study compared the safety and effectiveness of a new device (Yōni.Fit), a silicone device that can be inserted into the vagina with a sham device in treating urinary leakage that occurs when women cough, laugh, or sneeze. This type of urinary leakage is called stress incontinence. This study that took place at several institutions across the country, assigned patients with urinary leakage due to stress incontinence to this new device or a sham device, and collected information on how well the device worked and if any side effects occurred. Patients using the new device had significant improvement in their stress incontinence compared with a sham device with only mild side effects.
Stress urinary incontinence (SUI) is defined as involuntary loss of urine on physical exertion, sneezing, or coughing.1 It is a common problem affecting up to 35% of women and costing approximately 12 billion in direct costs for diagnosis treatment and care annually in the United States. 2–4 Treatment for SUI includes nonsurgical (pelvic floor muscle training, incontinence pessaries, and other bladder support devices) and surgical (urethral bulking, urethropexy, midurethral slings, autologous fascial slings) options. 5,6 Although surgical solutions typically have higher efficacy rates, they also have a greater risk of complications.7 The U.S. Food and Drug Administration (FDA) issued a safety communication in 2011 regarding surgical mesh placed through the vagina to treat pelvic organ prolapse. Although this communication was not inclusive of midurethral slings for the treatment of SUI and subsequent communications from the FDA re-enforced its proven safety and efficacy, 8 the negative media attention surrounding mesh has created confusion and fear regarding slings. This has led to a decrease in the number of women electing for surgical management with midurethral slings.9 Consequently, there is an increasing need for safe and efficacious nonsurgical options for women with SUI. While pelvic floor muscle exercises can be effective, they can be time consuming and not all women have the resources to access physical therapy if they cannot complete the exercises on their own. The other option for conservative therapy, pessaries, originally designed for the treatment of POP, were adapted for SUI and require a visit to a health care provider in order to be fitted properly.10
Recently there has been increased focus on vaginal inserts specifically designed for the treatment of SUI. However, the current inserts available either need to be fitted by a health care provider or their safety and efficacy has never been compared to controls.11–13 The objective of this study was to compare the safety and efficacy of a self-fitted novel intravaginal insert (Yōni.Fit) compared to a sham device (control group), for the treatment of SUI in women.
MATERIAL AND METHODS
This was a multicenter, randomized, sham-controlled, single-blind trial of adult women with stress predominate urinary incontinence (Clinicaltrials.gov ID: NCT03978741). An institutional review board approved the study protocol at each of the 3 participating sites. Participants were recruited from January 2020 to August 2022. Women self-reporting SUI and stress predominate mixed incontinence for ≥3 months were screened. Female patients, at least 18 years of age with a body mass index < 35 (calculated as weight in kilograms divided by height in meters squared) and a positive cough stress test result were included. Exclusion criteria are found in Appendix A, http://links.lww.com/FPMRS/A593.
Study Device
The Yōni.Fit device is a translucent, flexible, cone-shaped, 100% silicone vaginal insert device. The functional components include a cone-shaped core with a thickened rim. This rim is fortified with cross-linked support at one end that applies pressure against the vaginal wall and urethra (Figs. 1A, B). There is a handle at the other end that allows for the device’s easy removal from the vagina. The Yōni.Fit device comes in a range of sizes: 34 mm (size 1), 38 mm (size 2), 42 mm (size 3), 45 mm (size 3.5), 48 mm (size 4), and 52 mm (size 5). This device was investigational at the time of the study but now has FDA approval for prescription. The control treatment is a sham device. The sham device is a 100% medical grade silicone ring, which resembles an estradiol ring (Fig. 1C). It comes in 6 sizes: 27.4 mm (size 1), 31.5 mm (size 2) 33.2 mm (size 3), 40 mm (size 3.5), 44 mm (size 4), and 46 mm (size 5) to ensure blinding for the fitting phase of the study.
FIGURE 1.
Functional components of Yōni.Fit device, device placement, and control device. A, Study device. B, Placement of study device. C, Control device.
Study Design
All eligible participants at the first screening visit in the office setting underwent a history and physical examination, including a pelvic organ prolapse assessment using Pelvic Organ Prolapse Quantification and cough stress test.14 In addition, all patients completed a series of questionnaires, including the MESA Questionnaire (Medical, Epidemiological, and Social Aspects of Aging) and QUID Questionnaire (Questionnaire for Urinary Incontinence Diagnosis) to help determine eligibility. 15,16
The study schedule consisted of the following 5 phases: baseline (1 week), fitting (1 week), treatment (1 week), open-label (4 weeks), and follow-up (4 weeks) (Fig. 2). For the baseline phase, eligible participants completed baseline pad weight testing and a voiding diary for 1 week. For the pad weight testing, patients wore preweighed pads daily for 12 hours while awake. For premenopausal women, this phase was conducted within 1 or 2 days of the participant's menstrual period to avoid menstruation during the baseline phase, the randomization phase, and the treatment phase to ensure accuracy of the pad weight test. After the baseline phase, participants meeting all final eligibility requirements, including completion of at least 6 days of pad weight testing and a voiding diary, were randomized. All participants were randomized in a 1:1 fashion (Yōni.Fit device: control device) using a permuted block design stratified by site. Randomization of treatment was assigned from the electronic database randomization assignment module. Randomization was performed by designated unblinded staff at the investigational site. This was a single-blinded study. All participants were blinded to treatment assignments and the sponsor remained blinded until all participants had completed their treatment assessments. The investigators and staff were unblinded. After randomization, all participants entered a 1-week fitting phase. After a brief training, participants self-fitted inserts from 6 sizes, wore the insert daily for 12 hours, and were allowed to change sizes throughout the week to ensure a correct fit. Subsequently, participants entered the 1-week treatment phase, where they wore the correct fitting insert daily for 12 hours. After the treatment phase, participants had the choice to proceed with the open-label extension phase for 4 weeks to further assess safety of the device. Participants in the control arm could cross over to the treatment group. Control group participants not wishing to cross over could continue in the study without using their assigned devices, returning after 4 weeks for the withdrawal visit. The follow-up phase started immediately after the open-label phase and continued for 4 weeks. During this phase, patients did not wear the device but data on delayed long-term adverse events (AEs) were collected. Participants received compensation at each visit for their time and efforts. All sites participating in the study were standardized to follow the protocol.
FIGURE 2.
Overview of study schedule.
Outcome Measures
Outcome measures included 12-hour pad weight tests, voiding diaries, Patient Global Impression of Change (PGIC), Usefulness, Satisfaction, and Ease of Use (USE) Questionnaire, and Incontinence-Quality of Life (I-QOL) assessment questionnaire (Appendix B, http://links.lww.com/FPMRS/A594).
For the pad weight testing, patients wore preweighed pads for 12 hours per day while awake with no device in at baseline and then with the device in during the treatment phase (each for 1 week). Participants could use multiple pads as required. All worn pads were placed in a provided sealed bag and returned to the clinical site for weighing.
The primary efficacy endpoint was responder rate, where responder was defined as a patient who had ≥50% reduction in mean 12-hour pad weight test at the end of the treatment phase when compared with the baseline phase. Hypothesis-controlled secondary efficacy endpoints included percent change in mean pad weight from baseline to treatment phase, percent change in the frequency of SUI events from baseline to treatment phase, and responder rate for frequency of SUI events during the efficacy evaluation period, where responder was defined as a patient with ≥50% reduction from baseline in the number of SUI events per 12-hour period.
Nonhypothesis controlled secondary endpoints included pad dry days during the treatment phase, PGIC scores in the treatment and open-label phases, USE Questionnaire scores in treatment and open-label phases, and percent change in the I-QOL at treatment and open-label phases compared to baseline. Data on AEs were also collected in all phases.
Statistical Analysis
The statistical analysis plan was drafted and amended, and data were analyzed by Accudata Solutions, Inc, and NAMSA, unaffiliated with the sponsor. Based on available literature, it was expected that the responder rate for the control device group could be as high as 25%, and the performance of the Yōni.Fit test device was expected to be at least 58%.11,12 Using the Agresti-Caffo method of comparing proportions and these assumed response rates, 50 evaluable participants were required to achieve 80% power at a 1-sided α of 0.05 to demonstrate superiority of the test device over the control device.17 The primary analysis was a modified intention-to-treat approach, defined as analyzing all randomized participants except for participants meeting the nonfitter criteria according to the group to which they were assigned. Although primary and secondary efficacy analyses were to be conducted on a modified intention-to treat analysis set, with missing data replaced by multiple imputation, it was desired that 50 participants have observed data at the end of treatment phase. Seventy participants were targeted to be randomized to achieve 50 participants with observable data. Postrandomization dropouts and nonfitter rates were lower than expected, so once 58 participants had been randomized and 56 participants had reached the treatment phase, enrollment ceased. For missing data for primary and secondary efficacy evaluations, pad weights and SUI event counts were rank-transformed into normal scores using the Blom method and multiple imputation method followed using a multivariate normal Markov Chain Monte Carlo approach with 100 imputation datasets. Only 4 participants had missing data postrandomization for primary and secondary endpoints.
The primary efficacy endpoint of the 12-hour Pad Weight Responder was compared using the Agresti-Caffo method.17 There were 3 hypothesis-controlled secondary endpoints. The first, percent change in pad weight and second percent change in SUI events were analyzed using rank-based analysis of covariance (ANCOVA) model.18 Lastly, 12-hour SUI event responder rate was analyzed using the Agresti-Caffo method.17 Additional secondary efficacy endpoints included the following: PGIC (Mann-Whitney U test), percent change in I-QOL (ANCOVA), and proportion of pad dry days (repeated measures logistic regression model with generalized estimated equations). Statistical analyses were performed using SAS for Windows, version 9.4 (SAS Institute Inc., Cary, NC). This study was funded by Watkins-Conti Products, the manufacturer of the investigational device.
RESULTS
Seventy-nine patients were screened, 71 were enrolled, and 58 meeting eligibility criteria were randomized. Of randomized patients, 97% (56) completed the treatment phase, 93% (54) entered the open-label phase, 81% (47) completed the open-label phase, and 72% (42) completed the 30-day follow-up phase. Allocation and follow-up details are shown in Figure 3. The mean (SD) age of the cohort was 46.5 ± 10.6 years. Mean body mass index was 27.8, and most patients were premenopausal (62.7%). There was no substantive difference in demographic or baseline clinical characteristics between groups (Table 1). All particiants were able to self-fit the devices; therefore, no patients qualified as nonfitters.
FIGURE 3.
CONSORT diagram.
TABLE 1.
Patient Demographic and Clinical Characteristics
| Characteristic | Treatment Group | Total (N = 58) | ||
|---|---|---|---|---|
| Test (n = 31) | Control(n = 27) | |||
| Age | ||||
| Mean (SD) | 45.4 (11.2) | 47.9 (9.8) | 46.5 (10.6) | |
| Median (min, max) | 42.0 (30, 71) | 45.0 (35, 73) | 43.5 (30, 73) | |
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 9 (29.0%) | 7 (25.9%) | 16 (27.6%) | |
| Non-Hispanic or Latino | 22 (71.0%) | 20 (74.1%) | 42 (72.4%) | |
| Race, n (%) | ||||
| American Indian or Alaskan Native | 1 (3.2%) | 0 (0.0%) | 1 (1.7%) | |
| Asian | 3 (9.7%) | 6 (22.2%) | 9 (15.5%) | |
| Black or African American | 3 (9.7%) | 7 (25.9%) | 10 (17.2%) | |
| Native Hawaiian or Pacific Islander | 0 (0.0%) | 1 (3.7%) | 1 (1.7%) | |
| White (Caucasian) | 20 (64.5%) | 13 (48.1%) | 33 (56.9%) | |
| Not disclosed | 1 (3.2%) | 0 (0.0%) | 1 (1.7%) | |
| Other | 3 (9.7%) | 0 (0.0%) | 3 (5.2%) | |
| Education, n (%) | ||||
| High school | 3 (9.7%) | 2 (7.4%) | 5 (8.6%) | |
| Vocational training | 1 (3.2%) | 1 (3.7%) | 2 (3.4%) | |
| University | 19 (61.3%) | 19 (70.4%) | 38 (65.5%) | |
| Postuniversity graduate (Master, PhD) | 6 (19.4%) | 5 (18.5%) | 11 (19.0%) | |
| Postuniversity professional (MD, JD, DDS, DVM) | 2 (6.5%) | 0 (0.0%) | 2 (3.4%) | |
| Not disclosed | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Other | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Menopausal status, n (%) | ||||
| Premenopause | 24 (77.4%) | 15 (55.6%) | 39 (67.2%) | |
| Postmenopause | 7 (22.6%) | 12 (44.4%) | 19 (32.8%) | |
| BMI | ||||
| Mean (SD) | 27.47 (4.14) | 28.19 (4.99) | 27.81 (4.53) | |
| Median (min, max) | 27.70 (19.2, 34.5) | 26.90 (20.1, 36.5) | 27.30 (19.2, 36.5) | |
| Baseline MESA stress incontinence score* | ||||
| Median (min, max) | 17.0 (11, 23) | 18.0 (8, 24) | 17.0 (8, 24) | |
| Baseline MESA urge incontinence score* | ||||
| Median (min, max) | 5.0 (0, 11) | 5.0 (0, 13) | 5.0 (0, 13) | |
| Baseline QUID stress incontinence score* | ||||
| Median (min, max) | 9.0 (3, 14) | 10.0 (5, 15) | 9.0 (3, 15) | |
| Baseline QUID urge incontinence score* | ||||
| Median (min, max) | 4.0 (0, 6) | 4.0 (0, 6) | 4.0 (0, 6) | |
| Nocturia, n (%) | 6 (19.4%) | 6 (22.2%) | 12 (20.7%) | |
| Urinary retention, n (%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Overactive bladder, n (%) | 9 (29.0%) | 10 (37.0%) | 19 (32.8%) | |
| Pelvic organ prolapse, n (%) | 1 (3.2%) | 1 (3.7%) | 2 (3.4%) | |
| If yes, pelvic organ prolapse type, n (%) | ||||
| 1 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| 2 | 1 (3.2%) | 1 (3.7%) | 2 (3.4%) | |
| 3 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| 4 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Duration of experiencing urinary incontinence, n (%) | ||||
| <6 months | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| 6–12 months | 2 (6.5%) | 1 (3.7%) | 3 (5.2%) | |
| 1–2 years | 2 (6.5%) | 3 (11.1%) | 5 (8.6%) | |
| 2–5 years | 8 (25.8%) | 8 (29.6%) | 16 (27.6%) | |
| >5 years | 19 (61.3%) | 15 (55.6%) | 34 (58.6%) | |
*For both MESA and QUID, higher scores represent more frequent symptoms of incontinence.
BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); MESA, Medical, Epidemiologic, and Social Aspects of Aging; mITT, modified intent-to-treat; QUID, Questionnaire for Urinary Incontinence Diagnosis.
Results of the primary outcome showed a higher responder rate for the novel device compared to the control (51.6% vs 25.9%%, P < 0.05, preweight control 22.4 g, postweight control 24.45 g, preweight novel device 24.93 g, postweight novel device 9.96 g, absolute difference 29.6%, 95% confidence interval 7.4% to 51.8%). The secondary efficacy outcomes are shown in Table 2. For the hypothesis tested secondary efficacy outcomes, percent change in pad weight showed a greater reduction in the novel device compared to sham (−56.2% vs −17.7%, P = 0.003) and percent change in SUI episodes showed greater reduction in the novel device compared to sham (−88.8% vs −8.3%, P < 0.001). Additionally, greater than 50% reduction in SUI episodes from baseline occurred in 96.3% of participants using the novel device and 27.2% using sham (P < 0.001). The primary and secondary hypothesis tested efficacy outcomes were also analyzed for per protocol population, complete case analysis (patients with 6 or more days of pad weight in both the baseline and treatment phase) and with observed pad weights only (no imputation). Patients using the novel device had significantly better outcomes than patients using the control device.
TABLE 2.
Secondary Endpoints—Treatment Phase
| Novel Insert (n = 31) | Sham (n = 27) | P Value | ||||
|---|---|---|---|---|---|---|
| Secondary efficacy endpoints | ||||||
| 12-Hour pad weight percent change, median* | −56.2% | −17.7% | 0.003 | |||
| 12-Hour SUI event rate percent change mean† | −88.8% | −8.3% | <0.001 | |||
| 12-Hour SUI event responder rate, %‡ | 96.3% | 27.2.% | <0.001 | |||
| Pad dry day, est. % of days§ | 16.2% | 7.9% | 0.184 | |||
| PGIC “much improved” or better, n (%) | 24 (82.8%) | 10 (38.5%) | 0.001 | |||
| Secondary quality of life endpoints | ||||||
| I-QOL Scale score percent change from randomization, mean (SD) | ||||||
| Total | 36.93% (56.26) | 29.07% (61.24) | 0.271 | |||
| Avoidance and limiting behavior | 33.18% (53.61) | 37.86% (62.13) | 0.621 | |||
| Psychosocial effects | 35.51% (58.91) | 13.05% (46.89) | 0.057 | |||
| Social embarrassment | 113.45% (264.22) | 154.48% (404.93) | 0.977 | |||
| Use Questionnaire | ||||||
| Usefulness, mean (SD) | 5.95 (1.22) | 4.13 (2.43) | 0.008 | |||
| Ease of use, mean (SD) | 6.09 (1.04) | 5.90 (1.41) | 0.818 | |||
| Ease of learning, mean (SD) | 6.49 (0.82) | 6.45 (1.35) | 0.214 | |||
| Satisfaction, mean (SD) | 5.65 (1.56) | 4.56 (2.29) | 0.122 | |||
Bold indicates statistical significance.
*Missing data were imputed using multiple imputation based on rank transformation. The difference, confidence limit, and P value are from a rank-based ANCOVA model that adjusts for mean baseline value.
†Each subject’s rate of SUI events per 12 hours within the 7-day period has been computed after imputation of missing diary days.
‡An SUI event responder is a subject who achieves a 50% or more reduction in SUI events per 12 hours during treatment period when compared to baseline period.
§The estimates and P value were calculated from a repeated measures logistic regression model fit with generalized estimating equations. The pad wear time each day was treated as a continuous covariate. A pad day is considered dry if the posttest weight summed over all bags used that day minus the pretest weight summed over all bags used that day is less than 1.0 grams. The pad wear time each day was treated as a continuous covariate.
PGIC, Patient Global Impression of Change; SUI, stress urinary incontinence.
Among the nonhypothesis tested secondary efficacy outcomes, PGIC scores showed that at the end of treatment phase, more participants using the novel device felt their status was “much improved” or “better” compared to sham (82.8% vs 38.5% P = 0.001). There was no significant difference in pad dry days between the 2 groups.
Secondary quality of life outcomes are shown in Table 2. There were no significant difference in change in I-QOL scores (both total and subscale scores) from randomization to treatment assessment between the 2 groups. However, participants using the novel device scored higher on the USE Questionnaire subdomain of usefulness compared to the control group (P = 0.008).
Data collected in the open-label phase was for supportive purposes and safety data only. There was no significant change in total I-QOL scores from randomization to the end of the open-label phase (estimated difference 4.67, 95% confidence interval −17.30 to 26.64, P = 0.6700). There were no differences seen in subscale scores as well.
Treatment adherence was good in both groups during the treatment period. Patients were asked to wear the device for 7 days, 12 hours per day, and were asked to not switch device sizes from the size selected in the fitting period visit. Test patients used the device for an average (SD) of 13.1 (4.7) hours per day for an average (SD) of 6.6 (1.0) days, while control patients used the device for an average (SD) of 12.3 (2.5) hours per day for an average of 6.7 (0.8) days. Notably, the smallest average daily duration of wear was 7.3 hours in test and 8.3 hours in control patients, indicating that the least adherent patient still wore the device for most of the intended time. Eighty-five percent of the novel device group and 100% of the control group who reported the device size used maintained the same device size throughout the period.
There were no device-related serious AEs reported. One patient (1.8%)(control/crossed over to test device) experienced a serious AE (suicidal ideation), which was thought to be unrelated to the study device. In the novel device group, 17 (54.8%) patients experienced treatment emergent AEs during the 2-week treatment period versus in the control group, where 8 (29.6%) experienced a treatment emergent AE. There were only 2 (6.5%) patients in the test group who experienced an AE during the treatment period that led to study withdrawal versus none in the control. All device-related AEs were mild or moderate in severity. Common AEs were vaginal discomfort, bleeding, pain, itching, yeast infection, bruising, discharge, and dryness. Figure 4A shows breakdown and frequency of AEs during the treatment. The majority of the total AEs occurred in the first 5 days with a lower but fairly constant rate thereafter (Fig. 4B).
FIGURE 4.
A, Adverse events in treatment phase. B, Count of device-related adverse events by onset day relative to day of first exposure to Yōni.Fit device. Count includes subjects originally randomized to Yōni.Fit as well as subjects who had crossed over to Yōni.Fit during the open label period.
DISCUSSION
In this study, we found that a novel vaginal device (Yōni.Fit) improved objective and some subjective SUI outcomes as compared to sham. In terms of efficacy, more than half of the study patients (53.3%) using this device had at least a 50% reduction in their pad weight from baseline and the novel device reduced SUI episodes on their voiding diary by at least 50% in almost all (96.3%) study patients. There was a 100% successful self-fitting rate. Patients also reported that they found the novel device more useful compared to the control. Adverse events were mild or moderate in nature.
These efficacy outcomes are similar to other intravaginal devices that have been studied for SUI. An intravaginal device (Uresta, Resilia Inc, Canada) was studied in a single-blind randomized control trial and showed 66% of patients in the Uresta group compared to 22% of patients in the sham group (P = 0.01) achieved a 50% or greater reduction in pad weight after device placement.11 However, in this study, the patient only wore the device during a single office visit and our study shows efficacy sustained over a longer period of a week. Additionally, the Uresta device is also fitted by a health care provider, which limits its use to patients who seek medical care from health care providers trained to fit this device. The Yōni.Fit is a self-fitting device.
A second intravaginal device (Revive, Ovala Inc, Pittsburgh, PA) was studied in an open-label single arm study where participants completed baseline testing that was compared to results during a 2-week period wearing the device. Fifty-four percent of the population experienced greater than a 50% reduction in pad weights.12 These results were similar to our findings, but there was no control arm for this study. Additionally, this device is also only available in 1 size, which limits the number of patients able to be fitted for the device.
One of the more common vaginal inserts available on the market is the Poise Impressa (ConTIPI Ltd, Caesaria, Israel). The safety and efficacy of this device was evaluated in an open-label, single arm trial, which showed 85% of patients achieved a 70% or greater reduction in pad weight gain at 2 weeks of use. However again, there was no control arm for this study. Additionally, the study methods do not describe if patients with stress predominate mixed incontinence were included as in our study. Exclusion of this population may result in the higher reduction in pad weights. Additionally, AEs were reported in 68% of patients, which is higher than our study.13
Adverse events in other novel devices range from 30% to 68% of patients. Our study fell well within that range (54.8%) even though our follow-up for AEs was significantly longer than other published studies. The AEs observed in our study were also similar to those observed in other studies, which were vaginal discomfort, pain and spotting.11–13
The strengths of this study include the multicenter, randomized nature of the trial. It is the first of its kind to compare a novel intravaginal device to a control device for outcomes significantly longer than a single day. Another strength of the study was the sample size, with the power to detect clinically important differences and minimal loss to follow-up over the study. Finally, when compared to other studies of novel devices for SUI, the longer follow-up in our study design, which tracks AEs up to 30 days after use, is a strength and serves to capture any AEs that might have occurred during use and after removal of the device.
This study has several limitations. First, pad weights, while an objective outcome measure and commonly used in SUI research, are not an infallible outcome. Other types of incontinence (such urge urinary incontinence) can contribute to the weight of a pad, especially in patients with mixed incontinence, such as those included in our study. Also, it is important to note that some amount of pad weight gain is expected even in women without SUI due to perspiration, vaginal discharge, etc. Given this, a pad weight gain of ≤ 8 g/24 hours (approximately 333 mg/h) is considered normal.19
In conclusion, more patients using the novel vaginal device (Yōni.Fit) had a ≥ 50% reduction in pad weights, less SUI events and felt the novel device was more useful compared to sham. Adverse events were generally mild. This novel device will help add to the range of options patients have to treat stress-predominant urinary incontinence and specifically will increase options for self-administered interventions with lower risk profiles.
Supplementary Material
Footnotes
Sources of support and acknowledgment: The study was funded by Watkins-Conti products. The funding sources had no role or involvement in the analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication.
K.E. is part of the clinical advisory board of AbbVie and an educational consultant Coloplast and Medtronic. The other authors have declared they have no conflicts of interest.
The study was funded by Watkins-Conti products.
Supplemental digital content is available for this article. Direct URL citations appear in the HTML and PDF versions of this article on the journal’s website (www.urogynecologyjournal.org).
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