Comparison of Two Over the Counter Intravaginal Devices for the Treatment of Stress Urinary Incontinence (IMPRIVE)

Pelvic floor disorders (PFD) are common in the United States with an estimated 25% of women experiencing one of more pelvic floor disorder. PFDs include pelvic organ prolapse (POP), urinary incontinence (UI), and fecal incontinence (FI). These disorders have been associated with significant distress. Treatment options include both surgical and non-surgical management. Non-surgical options for treatment of stress urinary incontinence (SUI) include pelvic floor physical therapy, pessary, and over-the counter vaginal insertion devices. The Poise® Impressa® is an over-the-counter intravaginal device for women over the age of 21 years with SUI. It is a disposable, one-time use tampon-like device that comprises a core, cover, and applicator. The device is inserted and removed like a vaginal tampon and comes in three sizes. In an open-label controlled study, 60 women with severe urodynamic stress incontinence tested the device for 28 days. 85% of participants achieved a greater than 70% reduction in pad weight gain, and mean pad weight gain decreased from 17g per 8 hours to 2 g per 8 hours. A high degree of satisfaction was reported, and 70% of participants reported 90% improvement (Ziv et al). The Revive® is another over the counter vaginal insert for the treatment of SUI. This is a self-deployable, double-loop pessary device. (Ziev et al) conducted a multicenter, interventional, single-arm study and found 71% of the study population experienced a >50% reduction in leakage volume, leakage episodes, or both. Participants quality-of-life scores improved from baseline to post treatment phase by 4.35 points on average (p<0.0001).

Although over the counter vaginal inserts are a treatment option for SUI, it is not known if patients that are evaluated by medical practitioners are presented with this as a treatment as part of conservative management. The most recent Cochrane review on mechanical devices for the management of UI (Lipp et al., 2014) summarized the results of eight randomized trials reflecting the use of standard available intravaginal pessaries, tampons, and other intravaginal and intraurethral devices. As most trials were small, outcome measures were diverse, and few trials included control/no-treatment groups, the data regarding the use of mechanical devices for treatment of UI are still unclear. Additionally, some of these products are recommended in office by providers without current robust data regarding patient reported outcomes. The available data is limited to safety/efficacy data supported by the manufacturers of these devices. Ideally, this work could inform counseling and recommendations for providers that evaluate patients for stress urinary incontinence. For example, a subset of women that present for evaluation in clinic desire to proceed with surgical correction for SUI with urethral bulking or sling. In the interim prior to their scheduled surgery often only hygiene products can be offered that do not address the cause of leaking. Additionally, the market for these products is large and it is unclear how different women are experiencing these products. It is important to collect demographic information on who these products may be working the best for. This pilot project can help to collect some of these demographic information. Furthermore, there are a significant amount of women across the United States that do not have access to subspeciality urogynecologist or female urologists and use these devices without ever interacting with the healthcare system or getting a specific recommendation. For these women it is important that data exists from which they determine which of the commercially available devices may work best for them and may be more effective/affordable. Ultimately, this study will be helpful in determining the feasibility of the online format for this type of study. Also, once completed the information collected in this study could help to generate multiple hypotheses for larger confirmatory studies. Thus, further investigation into these treatment options is warranted. To date, no comparative trials have been performed to compare the Revive and the Impressa over the counter vaginal inserts in women seeking non-operative therapy for SUI. The investigators aim to perform a cross-over comparative effectiveness trial to evaluate SUI treatment success using two OTC vaginal inserts currently commercially available.

Prior to randomization participants will be sent the Poise Impressa sizing kit. Participants will then be asked what size of device works best for them based on the sizing kit. After this information is obtained that will then be sent both Revive and correct size of Poise Impressa. Participants will be randomized at this time. If participants are menstruating, participants will be asked to start this study after their last day of bleeding as this study will last approximately 20 days.

Example of participant timeline assuming randomized to Revive device first

Day 1-3

• Participant will perform ICIQ-SF, UDI-6, Incontinence Impact questionnaire (IIQ-7), Sandvik Severity Index
• Daily record of incontinence episode diary including number of pads used for incontinence

Week 1 (days 4-10)

• Revive® device
• UDI-6,IIQ-7, Sandvik severity index, ICIQ-SF)
• Device favorability score
• Patient global Impression of Improvement scale
• Daily record of incontinence episodes diary
• Satisfaction with device/comfort/success

Days (11-13) Three day wash out period with no incontinence device used

Week 2 (Days 14-20)

• Impressa® Device
• UDI-6, IIQ-7, Sandvik severity index, ICIQ-SF)
• Device favorability score
• Patient global Impression of Improvement scale
• Daily incontinence episodes diary
• Satisfaction with device/comfort/success

Statistical Analysis:

With planned enrollment of 80 patients and assuming a 20% dropout rate which is conservative compared to existing literature (McKay, H. Garth, et al), the investigators anticipate to have N=64 participants complete the study and provide rating for both device.

Sample size and estimates precision analysis The primary study end point will be the participants' preference on each device measured with a 5-level likert scale (Very favorable, favorable, neutral, unfavorable, or very unfavorable). The investigators conducted a simulation study with 64 participants (32 per sequence arm). In this simulation, the investigators assumed that participants were 20% more likely to choose Favorable/Very favorable for Impressa than for Revive. The results from a series of scenarios suggest that 60.9% of time, participants will prefer Impressa over Revive (by comparing the 5-lever likert scale), with a 95% confidence interval of 50% to 71.1% (assume 70% vs. 50% choose Favorable/Very favorable for the two devices respectively).

Statistical Analysis Plan All participants characteristics will be summarized using median with interquartile range (for continuous variables) and frequency with percentage (categorical variables). In the primary analysis, to allow the tie of rating for the two devices, the investigators will use the Prescott test to evaluate the difference of device preference measured by the 5-level likert scale (the primary endpoint). In a secondary analysis, the investigators will analyze the participants' rating for both devices as an ordinal outcome. The investigators will use ordinal regression models while taking into consideration the potential unbalanced participants characteristics. The investigators believe that the washout period used in this study is sufficient and carryover effect is unlikely.