Background
Intermittent self-catheterisation (IC) is considered to be the gold standard of care for people with neurogenic lower urinary tract dysfunction who are unable to empty their bladder (1). IC is coupled to lower levels of urinary tract infections and other complications, compared to indwelling catheterisation, that users unable to perform IC are forced to revert to (1).
Further, maintaining independence and preserving dignity during IC are key factors for individual's Quality of Life (QoL) and for adherence to the therapy. IC users may have limited hand dexterity and other physical challenges, and to enable these users to perform IC on their own in a dignified and hygienic manner is a challenge.
Aim of study
Investigate whether a new female catheter with an angulated handle and ergonomic design can improve quality of life (QoL) for individuals catheterising on a daily basis.
Materials and Methods
This prospective, single-arm study was conducted at 2 sites in Sweden and 2 in Spain. The study included 20 female subjects aged 18 years and over, with maintained urethra sensibility, who practised IC at least twice daily. The female catheter LoFric® Elle™ was used for two weeks, including the use of the versatile feature of the handle for at least 2 times a day. A validated Intermittent Self-Catheterization Questionnaire (ISC-Q) was used in conjunction to a study-specific questionnaire developed by Wellspect.
Results
The subjects reported a high QoL after using LoFric Elle, indicated by the analysis of the total ISC-Q with significantly higher values than 60 (baseline) (p=0.0007). The validated questionnaire showed that using LoFric Elle was associated with "ease of use", "discreetness" and "QoL", all three important attributes for long-term adherence and compliance to IC.
80% reported satisfaction with LoFric Elle
The satisfaction of users is a predictor of long-term adherence to IC
The Wellspect questionnaire results indicated that the subjects were satisfied with LoFric Elle, 80% reported totally or partially agreeing about catheter satisfaction.
85%
appreciated the versatility of being able to use the angulated handle of LoFric ElleFor women in need of assisted IC the handle may be associated with increased dignity because of the larger physical distance to the caregiver.
Likewise, the majority of subjects (85%), perceived LoFric Elle as versatile when used with or without the angulated handle, they found that the device was easy to hold when catheterising (75%) and that the use of the handle felt clean and hygienic (75%).
75%
perceived LoFric Elle easy to useThis is an important factor for women who catheterise on a daily basis to maintain dignity, independence and long-term bladder health.
75%
thought the LoFric Elle handle felt clean and hygienic to useNot having to put the hand down in the toilet bowel can reduce risks of foreign bacteria and UTIs.
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. LoFric Elle was perceived as safe and the few events reported were typically mild and transient.
Discussion
The fact that 80% reported catheter satisfaction with LoFric Elle is an important finding. The satisfaction of users is a predictor of long-term adherence to IC (2,3). Many women find it challenging to find the urethra and initiate catheterisation, especially if having torso instability due to spinal cord injury. These challenges might result in patients revert to indwelling catheters with an associated risk for urinary tract infections (UTIs) and other complications (4,5).
Conclusion
The results indicate that by using LoFric Elle women experience increased QoL and psychological well-being. 80% of the subjects were satisfied with the catheter and appreciated the versatility that the unique LoFric Elle handle offers with many different gripping possibilities, enabling users with varying levels of hand dexterity to hold and use LoFric Elle independently.
Further, it was appreciated to use the angulated handle for improved hygienic aspects, not having to put the hand down the toilet and avoiding urine sprinkles on their hands. Most users also perceived LoFric Elle easy to use with a slim, discreet, and non-medical design. Hence it can be concluded that LoFric Elle is a product that fits in everyday life, its design preserves dignity while also making catheterisation easy. These are all important factors for women who catheterise on a daily basis to be able to maintain independence and QoL.
Pernilla Sundqvist1
Angela Canós2
Prieto Chaparro2
Kaj Stenlöf3
Montserrat Baixauli4
Agustin Franco4
Anne-Marie Kivi5
Maria Lennerås5
- Division of Urology, Örebro University hospital, 701 85 Örebro, Sweden
- Hospital General, Alicante University, 1103010 Alicante, Spain
- Carlanderska hospital, research unit, 405 45, Gothenburg, Sweden
- Hospital Clinic Barcelona, 170 08036, Barcelona, Spain
- Wellspect Healthcare, Aminogatan 1, 43121 Mölndal, Sweden