IMPRIVE Pilot Study: Comparison of Two Over the Counter Intravaginal Devices for the Treatment of Stress Urinary Incontinence

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