While intermittent catheterization is the “gold-standard” to manage lower urinary tract dysfunction (LUTD), limited data exist on the daily experiences of individuals using intermittent self-catheterization (ISC). Successful health outcomes can be subjective and often depend on the participant’s perspective. Longitudinal data collected directly from individuals performing ISC for the management of bladder emptying would provide a relevant data source founded on the user’s daily use, habits, and experience. An electronic patient-reported outcome (ePRO) registry would be invaluable for prospective observational research aiming to investigate associations of ISC with quality of life (QoL), health resource utilization (HRU), symptoms associated with urinary tract infection (UTI), other complications, and overall intermittent catheter product satisfaction.

This study aims to build an ePRO registry of adult end users in outpatient and community settings using intermittent catheters for ISC to manage urinary retention and incomplete bladder emptying. Subsequent research resulting from data generated from a longitudinal ePRO registry will factor in end-user perspectives on ISC performance and will inform and guide healthcare professionals, end users, and caregivers in making the most informed healthcare decisions regarding ISC.

ConCaReTM continence care registry is a multinational registry designed as a prospective, observational longitudinal study among individuals who perform ISC. Recruitment efforts focus on community-dwelling individuals aged 18 and older using ISC who can self-enroll in the registry on a rolling basis. Currently, ISC users living in the United States and Canada are enrolled in the registry with enrollment now open in the United Kingdom. Questionnaires are electronically distributed monthly for one year, then quarterly for up to five years and include the Intermittent Self-Catheterization Questionnaire (ISC-Q), EuroQoL-5D, and RAND modified Medical Outcomes Study Social Support Survey, which explore quality of life and satisfaction, health care utilization, and factors influencing catheter choice.

Baseline data from 95 (72% United States; 28% Canada) participants over the age of 18 (82% male) are presented. Eighty-seven (87) of the 95 participants (92%) self-reported having conditions associated with neurogenic LUTD. Ninety-three (93) participants reported the number of times they self-catheterize within a 24-hour period. Of the 93 who reported daily self-catheterization frequency, 82% reported catheterizing 4 or more times within a 24-hour period (Table 1). Seventy-two (72) of the 95 participants (76%) self-reported being very satisfied or somewhat satisfied with the amount of time it takes to catheterize. Results of ISC-Q questions in the Ease of Use domain indicated that sixty-seven (67) of the 95 participants (71%) responded “strongly agreed” or “slightly agreed” to the ease for preparing their catheter for use each time they need it and 95 participants (95%) reported they either “strongly agreed” or “slightly agreed” to feeling confident in their ability to use their catheter (Table 2). 
Fifty-nine (59) of 93 participants (63%) reported using a hydrophilic coated catheter (Table 1). Out of those 59 participants, 75% reported being very satisfied or somewhat satisfied with the amount of time it takes to catheterize. Forty-four (44) of the 59 participants (75%) either strongly agreed or slightly agreed that it is easy to prepare their catheter for use each time they need it (Table 2).

According to Leroux et al. (2021), the median total time to ISC, which includes the time to gather the necessary materials, moving and transferring to the toilets or bed if necessary, and time to self-catheterize until the return to their initial activities, was 3 minutes and 40 seconds ranging from 1 minute and 35 seconds to 18 minutes and 47 seconds.[1] In this registry, 82% of participants reported they self-catheterize four or more times within a 24-hour period. The median total time to ISC for an individual self-catheterizing four times was estimated to be 14 minutes and 40 seconds per day (ranging from 6 minutes and 20 seconds to 74 minutes and 21 seconds). However, even with this amount of time used to self-catheterize, most participants reported being satisfied to some degree with the time it takes to self-catheterize. This level of satisfaction with time used to self-catheterize is also consistent with those using hydrophilic catheters. Findings from Leroux et al. showed no correlation between a longer ISC completion time and a poorer adherence, satisfaction, or quality of life. However, the small sample size (n=25) was cited as a limitation to this study.[1] ConCaReTM continence care registry may be able to overcome this limitation in the Leroux et al. study. As ConCaReTM continence care registry expands into other countries and the sample size increases, the data may provide further insights into the effect satisfaction with the time to self-catheterize has on quality of life, adherence, and product choice.
In ConCaReTM continence care registry, 71% of the participants reported that they agreed their catheter was easy to prepare for use each time they need it. Those using hydrophilic catheters included a slightly higher percentage of participants at 75%. Catheters that reduce the number of preparations/procedural steps, pain, and UTIs are likely to improve QoL and long-term adherence.[2] Data from ConCaReTM continence care registry may help to inform key stakeholders such as clinicians and payors of the impact consistent ease of preparation may have on QoL and long-term adherence over time.
At baseline, 95% of the participants reported feeling confident in their ability to use their catheter. In a study by Roberson et al, it is suggested that confidence in the ability to use the catheter is important and may be the result of successful patient education and catheter design.[3] Longitudinal data provides an opportunity to track changes in participants’ confidence in their ability to catheterize over time. Any decrease in confidence may help highlight unmet educational support needs, deteriorations in health, or changes in dexterity.

As recruitment approaches the recruitment target [600 participants], outcomes will continue to be monitored over time. Data yielded from the ConCaReTM continence care registry will help to characterize ISC utilization in different populations by gender, age, location, and comorbidities. A better understanding of the ISC user’s experience over time will help to inform clinicians to identify areas of unmet patient needs and opportunities for clinician support.

Leroux C, Turmel N, Chesnel C, et al. Determinants and impact of the time to perform clean intermittent self-catheterization on patient adherence and quality of life: A prospective observational study. NeurourolUrodyn. 2021; 40: 1027-1034. https://doi.org/10.1002/nau.24662.
Newman DK, New PW, Heriseanu R, et al. Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life. International Urology and Nephrology. 2020; 52:1443-1451. https://doi.org/10.1007/s112255-020-02435-9.
Roberson D, Newman DK, Ziemba JB, et al. Results of the patient report of intermittent catheterization experience (price) study. NeurourolUrodyn. 2021;1-12. https://doi.org/10.1002/nau.24786.

Continence 7S1 (2023) 100986
DOI: 10.1016/j.cont.2023.100986