Development and psychometric evaluation of the ICIQ-LTCqol: A self-report quality of life questionnaire for long-term indwelling catheter users.

AIMS: Long-term indwelling catheterisation may affect health related quality of life, but clinical assessment and monitoring of people with indwelling catheters is poorly recorded because there are no validated measures to capture these criteria. In this paper, we describe the development of the ICIQ-Long Term Catheter quality of life (ICIQ-LTCqol), one of the modules of the ICIQ series, an international project to standardise assessment of lower pelvic dysfunction: www.iciq.net. METHODS: In-depth interviews were conducted with 27 catheter-users and 4 informal carers and cognitive debriefing with a further 31 catheter-users and clinical experts to evaluate clarity and comprehensiveness. The draft 44 item questionnaire was then sent by post to 893 long-term catheter-users; the 370 completed questionnaires were used to test content validity, test re-test reliability and internal consistency (Cronbach α coefficient). Factor analysis alongside expert opinion was used to formulate the final questionnaire of 16 items. This was then sent by post to another 438 long-term catheter-users to evaluate domain scores. RESULTS: The final questionnaire consists of two scored domains: catheter function and concern (9 items) and lifestyle impact (3 items) and four standalone items, relating to pads, pain, sexual activity and bladder spasm. Levels of missing data are good (mean 3.6%) with moderate to good agreement and acceptable internal consistency (Cronbach's alpha 0.76 and 0.74 for each domain respectively), suggesting acceptability and stability of the questionnaire. CONCLUSION: The ICIQ-LTCqol is a psychometrically robust self-report questionnaire for the clinical assessment and evaluation of health related quality of life for long-term catheter users.

Novel Insights into the Proteus mirabilis Crystalline Biofilm Using Real-Time Imaging.

The long-term use of indwelling catheters results in a high risk from urinary tract infections (UTI) and blockage. Blockages often occur from crystalline deposits, formed as the pH rises due to the action of urease-producing bacteria; the most commonly found species being Proteus mirabilis. These crystalline biofilms have been found to develop on all catheter materials with P. mirabilis attaching to all surfaces and forming encrustations. Previous studies have mainly relied on electron microscopy to describe this process but there remains a lack of understanding into the stages of biofilm formation. Using an advanced light microscopy technique, episcopic differential interference contrast (EDIC) microscopy combined with epifluorescence (EF), we describe a non-destructive, non-contact, real-time imaging method used to track all stages of biofilm development from initial single cell attachment to complex crystalline biofilm formation. Using a simple six-well plate system, attachment of P. mirabilis (in artificial urine) to sections of silicone and hydrogel latex catheters was tracked over time (up to 24 days). Using EDIC and EF we show how initial attachment occurred in less than 1 h following exposure to P. mirabilis. This was rapidly followed by an accumulation of an additional material (indicated to be carbohydrate based using lectin staining) and the presence of highly elongated, motile cells. After 24 h exposure, a layer developed above this conditioning film and within 4 days the entire surface (of both catheter materials) was covered with diffuse crystalline deposits with defined crystals embedded. Using three-dimensional image reconstruction software, cells of P. mirabilis were seen covering the crystal surfaces. EDIC microscopy could resolve these four components of the complex crystalline biofilm and the close relationship between P. mirabilis and the crystals. This real-time imaging technique permits study of this complex biofilm development with no risk of artefacts due to sample manipulation. A full understanding of the stages and components involved in crystalline encrustation formation will aid in the development of new protocols to manage and ultimately prevent catheter blockage.

Intermittent catheterisation for long-term bladder management (abridged cochrane review).

AIMS: To review the evidence on strategies to reduce UTI, other complications or improve satisfaction in intermittent catheter (IC) users by comparing: (1) one catheter design, material or technique versus another; (2) sterile technique versus clean; or (3) single-use (sterile) or multiple-use (clean) catheters. METHODS: We searched Cochrane Incontinence Group Specialised Trials Register, MEDLINE, EMBASE, CINAHL, ERIC, reference lists, and conference proceedings to November 2013. We contacted other investigators for unpublished data or clarification. Trial screening, assessment and data abstraction were all in accordance with the Cochrane handbook. RESULTS: Thirty one trials (13 RCTs and 18 randomized crossover trials), addressed the inclusion criteria comparing method or design and UTI/bacteriuria, other complications or participant assessed outcomes. Studies varied widely in follow-up, UTI definition and attrition; in some, data could not be combined. Where there were data, confidence intervals were wide and hence clinically important differences could neither be reliably identified nor ruled out. CONCLUSIONS: Current research evidence is weak and design issues are significant. It has not yet been established whether incidence of UTI, other complications such as haematuria, or user satisfaction are affected by sterile or clean technique, coated or uncoated catheters, single or multiple-use catheters or by any other strategy. For people using IC, choice of catheter will depend on personal preference, cost, portability, and ease of use. Individuals should discuss the catheter options with their healthcare practitioner. Cost-effectiveness analysis and use of the standard definition of UTI are essential in any proposed clinical trial.

A trial of devices for urinary incontinence after treatment for prostate cancer.

OBJECTIVE: To compare the performance of three continence management devices and absorbent pads used by men with persistent urinary incontinence (>1 year) after treatment for prostate cancer. PATIENTS AND METHODS: Randomised, controlled trial of 56 men with 1-year follow-up. Three devices were tested for 3 weeks each: sheath drainage system, body-worn urinal (BWU) and penile clamp. Device and pad performance were assessed. Quality of life (QoL) was measured at baseline and follow-up with the King's Health Questionnaire. Stated (intended use) and revealed (actual use) preference for products were assessed. Value-for-money was gathered. RESULTS: Substantial and significant differences in performance were found. The sheath was rated as 'good' for extended use (e.g. golf and travel) when pad changing is difficult; for keeping skin dry, not leaking, not smelling and convenient for storage and travel. The BWU was generally rated worse than the sheath and was mainly used for similar activities but by men who could not use a sheath (e.g. retracted penis) and was not good for seated activities. The clamp was good for short vigorous activities like swimming/exercise; it was the most secure, least likely to leak, most discreet but almost all men described it as uncomfortable or painful. The pads were good for everyday activities and best for night-time use; most easy to use, comfortable when dry but most likely to leak and most uncomfortable when wet. There was a preference for having a mixture of products to meet daytime needs; around two-thirds of men were using a combination of pads and devices after testing compared with baseline. CONCLUSIONS: This is the first trial to systematically compare different continence management devices for men. Pads and devices have different strengths, which make them particularly suited to certain circumstances and activities. Most men prefer to use pads at night but would choose a mixture of pads and devices during the day. Device limitations were important but may be overcome by better design.

The effect of caffeinated versus decaffeinated drinks on overactive bladder: a double-blind, randomized, crossover study.

PURPOSE: The primary aims of this study were to test the methodology for use in a future randomized control trial and to investigate the effect of drinking caffeinated versus decaffeinated fluids on symptoms of overactive bladder (OAB) in women. DESIGN: A double-blind, randomized, crossover study was conducted. METHODS: Fourteen community-dwelling women newly diagnosed with OAB and a history of caffeine consumption were randomly allocated to group A (14-day caffeinated drink period followed by 14-day decaffeinated drink period) or group B (14-day decaffeinated drink period followed by 14-day caffeinated drink period). The periods were preceded by a 14-day run-in period and interspersed with a 14-day washout period. Primary outcomes were episodes of urgency, frequency, volume per void, and incontinence obtained each period on 3-day bladder diaries. Secondary outcome measures were OAB symptom severity and health-related quality of life (QOL) recorded each period using International Consultation on Incontinence-Overactive Bladder Module (ICIQ-OAB) and ICIQ-OAB-Quality of Life (ICIQ-OABqol) tools. Effects of caffeine reduction were measured each day using visual analogue scales. RESULTS: Eleven participants completed the study. A significant reduction in urgency (P < .01) and frequency (P < .05) of urinary voids on day 3 of the diary, total ICIQ-OAB score (P < .01), and a non-significant directional change for the total ICIQ-OABqol score (P = .065) was found using sign tests for the period of decaffeinated compared to caffeinated drink intake. No significant differences were found for any caffeine withdrawal measures. CONCLUSIONS: Despite the small sample size, this pilot study demonstrated that reducing caffeine intake may alleviate the severity of some symptoms and health-related QOL factors associated with OAB. Furthermore, caffeine substitutes were well tolerated.

Individual budgets for people with incontinence: results from a 'shopping' experiment within the British National Health Service.

BACKGROUND AND CONTEXT: Most people with urinary incontinence are given limited choice when provided with absorbent products through the British National Health Service (NHS), even though the available range is large. OBJECTIVE: To investigate users' preferences for four disposable designs (inserts, all-in-ones, belted/T-shaped and pull-ups) and towelling washable/reusable products, day and night. DESIGN: Shopping experiment. SETTING AND PARTICIPANTS: Community-dwelling women and men in England with moderate-to-heavy urinary incontinence recruited to a larger trial. INTERVENTION: Participants tested each design and selected products they would prefer with a range of different budgets. MAIN OUTCOME MEASURES: Design preferences (rankings); 'purchasing' decisions from designated budgets. Results Eighty-five participants (49 men) tested products, 75 completed the shopping experiment. Inserts, most frequently supplied by the NHS, were ranked second to pull-ups by women and lowest by men. When faced with budget constraints, up to 40% of participants opted to 'mix-and-match' designs. Over 15 different combinations of products were selected by participants in the shopping experiment. Most (91%) stated a willingness to 'top-up' assigned budgets from income to secure preferred designs. DISCUSSION: Participants displayed diverse preferences. Enabling user choice of absorbent product design through individual budgets could improve satisfaction of consumers and efficiency of allocation of limited NHS resources. CONCLUSION: Recent policy for the NHS seeks to provide consumers with more control in their care. Extension of the concept of individual budgets to continence supplies could be feasible and beneficial for patients and provide better value-for-money within the NHS. Further research is warranted.