Intermittent self-catheterization (IC) has become the gold standard for bladder emptying in people with neurogenic lower urinary tract dysfunction. Urinary leakage is often associated with embarrassment and may lead to isolation from social activities and even depression. To be able to regain control over bodily functions and maintaining independence and dignity during catheterization are key factors for the individual’s quality of Life (QoL). A non-medical design of the product and a discreet package may also be important to be compliant to the therapy, which for many last for a lifetime. The aim of this study was to investigate the QoL after 14 days, using a new female catheter, LoFric® Elle, with an angulated handle.

This was a prospective, single-arm study conducted at four sites in Europe (2 sites in Sweden and 2 in Spain). The inclusion criteria were female subjects aged 18 years and over, with maintained urethra sensibility, experienced in IC, and practicing IC at least twice daily. The female catheter LoFric® Elle was used and subjects were instructed to use the versatile feature of the handle, at least 2 times a day. The primary objective was to investigate the QoL via the validated questionnaire ISC-Q of subjects practicing IC with LoFric® Elle. The secondary objectives were to evaluate the compliance, satisfaction, and perception of the subjects when using LoFric® Elle via specific domains of the ISC-Q score and the Wellspect questionnaire, as well as to monitor the safety.

A total of 20 subjects fulfilling the eligibility criteria were included in the study. The mean age of the subjects was 56 years, and they had various urological (50%), neurological (35%), and surgical reasons (15%) for emptying their bladder with IC. The analysis of the total ISC-Q results showed significantly higher values than 60 (baseline) (p=0.0007), indicating that the subjects reported a high QoL after using LoFric® Elle. The evaluation of each domain of the ISC-Q score revealed that the “ease of use”, “discreetness” and “psychological well-being” domains scored significantly higher than 60, indicating that these parameters were associated to a positive outcome after using LoFric® Elle, all three important attributes for long-term adherence and compliance to IC. The Wellspect questionnaire results indicate that the subjects were satisfied with LoFric® Elle, 80% reported totally or partially agreeing about catheter satisfaction. Likewise, the majority of subjects perceived LoFric® Elle as versatile when used with or without the angulated handle (85%), they found that the device was easy to hold when catheterizing (75%) and that the use of the handle felt clean and hygienic (75%). The results of the ISC-Q “convenience” and “discreetness” domain scores confirm the positive perception of the subjects, as they found LoFric® Elle “slim and discreet” (78%) and “easy to use” (78%) after using it for 14 days.

The results indicate that by using LoFric® Elle women experience increased QoL and psychological well-being. 80% of the subjects was satisfied with the catheter and appreciated the versatility of being able to use the angulated handle for improved hygienic aspects and not having to put the hand down the toilet.

The majority of users perceived LoFric Elle easy to use with a slim, discreet and non-medical design. These are all important factors for women who catheterize on a daily basis to be able to maintain their dignity, independence and QoL.