Several recent publications have brought attention to the increased prevalence of stress urinary incontinence during high impact sports, with reported prevalence ranging from 26% up to as high as 86%. [1,2]. It is our understanding that many women who experience exercise induced urine leakage, does not seek medical help, or even define themselves as being incontinent. It is regarded as a part of life and the remedy is often to refrain from the activity. However, the availability of “over the counter” vaginal support pessaries, to reduce urine leakage, might enable these women to continue being active. The aim of the two post market surveillance studies presented here was to evaluate the user acceptance of a vaginal support pessary, Efemia bladder support (figure 1), to prevent urine leakage during high impact exercise.

Two studies were designed as observational user satisfaction studies and performed in adherence with the ICC/ESOMAR international code of marketing and social research. 
Recruitment, informed consent, subject ID-log and distribution of questionnaires and study products was handled by study administrators independent from the sponsor. The identity of the participants was not revealed to the study sponsor.
19 female participants, suffering from urine leakage during exercise, but not previously diagnosed with SUI, were recruited at a weight-lifting gym (study TVS4000) and 9 women experiencing urine leakage during CrossFit® exercise were recruited by a urotherapist at Skelleftea hospital (study TVS5000). Participants received a free package containing the three sizes of Efemia bladder support. No other compensation or rewards were received for participation.
The participants fitted the device and selected the suitable size in their homes, by themselves in accordance with the IFU. After 6 weeks of using the bladder support, the participants answered questions regarding user satisfaction through an electronic questionnaire.
The sample sizes of the TVS4000 and TVS5000 studies were not based on power calculations, since the primary endpoint was user satisfaction and they do not contain any hypothesis evaluations. It was estimated that a sample size of 20 women would represent a sufficient basis for evaluating user satisfaction during exercise.

Of the 28 women recruited to the two studies, 21 (75%) completed the study and used Efemia during at least one work out session. 4 participants were lost to follow-up and 3 participants discontinued the study. Reasons for discontinuation were: No incontinence (n=1), Irregular menstruation (n=1), difficult to place the device correctly (n=1)
User satisfaction with the device was high. The most frequent answer to the questions if they were likely to continue using the product or recommend it to a friend was 10, “Very likely”. Of the 21 women that used the bladder support during exercise, 18 women (81 %) reported that it reduced leakage “a lot” or “quite a lot” and 4 women (19%) reported that it reduced leakage “partly”. 6 of the 9 women that used the bladder support outside of the gym reported that it had facilitated their daily lives “Quite a lot” Individual responses are shown in table 1

The data showed a high user satisfaction when using the vaginal support pessaries during weightlifting or CrossFit® exercise. 86% of the women were likely to continue to use the product and 90% were likely to recommend the product to a friend (response ≥ 6 on a scale of 0-10). However, it is important to note that the evaluation is based on a total of 21 women. Studies, involving other sports and more women would therefore be useful for evaluating the use of vaginal inlays during high impact exercise.

For women diagnosed with SUI, the device has previously been proved effective and safe [3]. The data presented here shows that a vaginal support pessary can improve the daily lives of active women experiencing urine leakage during physical exercise, who might not see themselves as generally incontinent and therefore do not seek medical help.

Elks W, Jaramillo-Huff A, Barnes KL, Petersen TR, Komesu YM. The Stress Urinary Incontinence in CrossFit (SUCCeSS) Study. Female Pelvic Med Reconstr Surg. 2020 Feb;26(2):101-106.
Wagener S, Hoppe MW, Hotfiel T, et al. CrossFit® – Development, Benefits and Risks. Sportorthopa¨die-Sporttraumatologie. 2020;36(3):241-249.
Jonasson AF, Bryder K, Sthengel E. A Vaginal Inlay for Reduction of Stress Urinary Incontinence: Outcome of a Randomized Clinical Trial and Four User Acceptance Studies. Adv Urol. 2021;2021:8822186. Published 2021 Feb 15.