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Biomedical subjects

J Malone-Lee

Publications and source records attributed to J Malone-Lee.

At least 19 recordsLinked to original sources
PubMed2001

Sheaths for urinary incontinence: a randomized crossover trial.

OBJECTIVE: To evaluate the full range of self-adhesive continence sheaths for men available in the UK and thus provide clinicians and consumers with a basis for product selection. PATIENTS AND METHODS: Fifty-eight volunteers (aged 30-89 years) tested each of six different self-adhesive sheaths available in the UK in September 1998 for 1 week each. Thirty subjects applied the sheaths themselves and 28 subjects relied on a carer to do so. During each week subjects completed a diary recording sheath changes and the result of skin inspection, to note any unscheduled sheath changes (because of sheath detachment) and any skin problems. At the end of each week an 11-item questionnaire was completed using a three-point rating scale ('good', 'acceptable', 'unacceptable') to assess the key aspects of product performance. RESULTS: A significantly higher proportion of subjects scored the 'Aquadry Clear Advantage' sheath as 'good' than four of the other sheaths (P < 0.01) and a significantly higher proportion found the 'Incare' sheath to be 'unacceptable' than all of the other sheaths (P < 0.001) for the 'overall opinion' question. Sheath detachments (sheath falling off or blowing off) for the 'Incare' were significantly more common than for four of the other products (P < 0.01). Sheath detachments for the 'Aquadry Clear Advantage' were significantly less common than for two of the other products (P < 0.01). A significantly higher proportion of subjects found sheaths with an applicator to be 'unacceptable' than sheaths with no applicator (P < 0.001) for the 'ease of putting on' and 'overall opinion' questions (when adjusted for previous product use and person applying the sheath). CONCLUSIONS: There were substantial differences between products in their general performance and ergonomics, and for the frequency of detachment as recorded in the diary. The 'Aquadry Clear Advantage' was particularly successful and the 'Incare' particularly unsuccessful when compared with the other sheaths. Sheaths with no applicators were preferred to those with applicators. Applicators are mainly designed to make sheaths easier to put on, especially for carers, but there was no evidence that carers preferred applicators. This may have implications for manufacturers.

Adult↗
PubMed2001

Coated catheters for intermittent catheterization: smooth or sticky?

OBJECTIVE: To evaluate the current range of hydrophilic-coated catheters for intermittent self-catheterization, focusing on the adherence of the catheter to the urethral mucosa at the end of catheterization. PATIENTS AND METHODS: In a prospective randomized study, 61 community-based men tested each of four different hydrophilic-coated catheters available in the UK at the time. Subjects used each of the four test catheters for 1 week in a random order, and were provided with the number and size of catheter they normally used. To assess the products, the subjects: (i) timed seven catheterizations using a stop-watch to determine the time taken from extracting the catheter from the water-filled package, to removing the catheter from the penis, having emptied the bladder; (ii) recorded the severity of 'sticking' on catheter removal on a three-point scale (not at all, a little, a lot); and (iii) completed a product-performance questionnaire. RESULTS: There were no significant differences in ratings of 'sticking' between the 'Easicath' and 'Lofric' (P > 0.05), but there were significant differences between these two products and the 'Aquacath' and the 'Silky', which were found to 'stick' more (P < 0.001). The 'Silky' was reported to stick significantly more than the 'Aquacath' (P < 0.001). CONCLUSIONS: Adherence to the urethral mucosa on catheter removal was a common problem, occurring with all catheters, but two products were significantly more likely to stick than the other two. The clinical importance of 'sticking' and the long-term implications are currently unknown. The relative 'sticking' of uncoated catheters has also not been established.

Adult↗
PubMed2001

Twelve-month treatment of overactive bladder: efficacy and tolerability of tolterodine.

CONTEXT: Tolterodine is a bladder-selective antimuscarinic agent designed for the treatment of overactive bladder. Traditional antimuscarinic therapies are poorly tolerated due to a high incidence of anticholinergic adverse events and consequently few patients remain on long term therapy. OBJECTIVE: To evaluate the long term efficacy and tolerability of tolterodine in patients with symptoms of overactive bladder. DESIGN: Twelve-month open-label extension of 4 randomised, placebo-controlled, double-blind, multinational, multicentre trials of 4 weeks' duration. PATIENTS: 714 patients (aged 18 to 92 years) with symptoms of overactive bladder who completed the double-blind portion of the studies. INTERVENTION: Tolterodine 2 mg twice daily for up to 12 months. MAIN OUTCOME MEASURES: Micturition diary variables: number of micturitions per 24 hours, number of urge incontinence episodes per 24 hours, mean urine volume voided per micturition. Safety variables: adverse events, study discontinuation rate. RESULTS: A total of 441 patients (62%) completed 12 months' open-label treatment with tolterodine, which significantly reduced the number of micturitions per 24 hours [mean change -2.4, 95% confidence interval (CI) -2.7 to -2.2, median change -20%, p < 0.0001] and number of urge incontinence episodes per 24 hours (mean change -1.3, 95% CI -1.6 to -1.0, median change -74%, p < 0.0001), while the mean volume voided per micturition was significantly increased (+33 ml, 95% CI +28 to +38, median change +18%; p < 0.0001). 41% of patients reported dry mouth (27% mild, 10% moderate, 3% severe). Dosage reduction to 1 mg twice daily was required in 23% of patients. 15% of patients withdrew from the study due to adverse events, with 5% having associated dry mouth. CONCLUSIONS: The high percentage of patients completing 12 months' treatment indicates that tolterodine is an effective and well tolerated agent for long term treatment of overactive bladder.

Adolescent↗
PubMed2001

Tolterodine: superior tolerability than and comparable efficacy to oxybutynin in individuals 50 years old or older with overactive bladder: a randomized controlled trial.

PURPOSE: We compared the tolerability and clinical efficacy of tolterodine with those of oxybutynin in patients with an overactive bladder using an upward oxybutynin dose titration strategy analogous to that used in routine clinical practice in the United Kingdom and Republic of Ireland. MATERIALS AND METHODS: In a randomized double-blind trial 378 male and female patients 50 years old or older with symptoms of overactive bladder (a urinary frequency of 8 or more voids per 24 hours with urgency and/or urge incontinence, that is 1 or more urge incontinence episodes per 24 hours) received 10 weeks of treatment with 2 mg. tolterodine twice daily/or an initial dose of 2.5 mg. oxybutynin twice daily, increasing to 5 mg. twice daily after 2 weeks of treatment. The main outcome measures were changes in voiding diary variables combined with detailed tolerability-safety assessments. RESULTS: Patients treated with tolterodine had significantly fewer adverse events (69% versus 81%, p = 0.01), notably dry mouth (37% versus 61%, p <0.0001), as well as a lower incidence of dose reduction (6% versus 25%, p <0.0001) than those in the oxybutynin group. Each agent had comparable efficacy for improving urinary symptoms. Tolterodine and oxybutynin caused a significant decrease (p = 0.0001) in the mean number of voids per 24 hours (-1.7 or -15% and -1.7 or -15%, respectively), urge incontinence episodes per 24 hours (-1.3 or -54% and -1.8 or -62%, respectively) and mean voided volume per void (33 ml. or 22% and 34 ml. or 23%) after 10 weeks of treatment. CONCLUSIONS: Tolterodine is as effective as oxybutynin for improving the symptoms of overactive bladder but it has superior tolerability. The combination of these qualities makes tolterodine the preferred pharmacological therapy for the long-term treatment of this condition.

Aged↗
PubMed2000

Overactive bladder: special considerations in the geriatric population.

Overactive bladder (OAB) is a highly prevalent condition among older patients, and its presence is associated with the use of substantial healthcare resources and economic costs. Within the next 30 years, it is expected that the demand for services related to OAB will increase dramatically. Treatment of OAB is challenging and depends on several factors, including the age of the patient, cognitive functioning, and the degree of mobility. Pharmacotherapy, such as the use of tolterodine and oxybutynin, is a viable option for the treatment of OAB, and muscarinic antagonists are commonly used. The efficacy of an agent may differ in older patients compared with younger ones. In addition, certain side effects can be particularly troublesome in the geriatric population. A retrospective analysis of a large managed care database showed an age-related increase in the number of women seeking care for OAB. Caring for incontinent patients in the long-term care setting was shown to result in substantial additional costs, which were higher in those with more frequent incontinent episodes. Prompted voiding may be effective in reducing the number of incontinent episodes for those in institutionalized care; however, this practice is labor intensive and generally is only effective in 40% of cases. Moreover, assistance with prompted voiding must be maintained continuously. Future research should focus on defining the most cost-effective methods of treating OAB in the long-term care setting.

Adult↗
PubMed1998

Urodynamic variables cannot be used to classify the severity of detrusor instability.

OBJECTIVE: To explore the relationship between subjective severity of symptoms of detrusor instability (DI) on presentation, outcome after treatment for DI and initial diagnostic urodynamic variables, with the aim of identifying a urodynamic variable which might, by predicting a favourable outcome from treatment, classify the severity of DI. PATIENTS AND METHODS: Women with a urodynamically proven diagnosis of DI were recruited prospectively for the study. Data on disease symptoms and variables from their diagnostic cystometrogram were collected. All women were then treated and their outcome at 6 weeks after treatment compared with the initial urodynamic variables. Data on severity of symptoms were compared with initial urodynamic variables to explore any differences in these variables attributable to symptom severity. RESULTS: Of 300 women studied (mean age 54 years, SD 16), 290 were treated with oxybutynin and bladder retraining. At 6 weeks, 82 women had their treatment outcome classified as worse/no change; 218 women had improved. When good or poor outcome was compared with the urodynamic results, there was no significant difference between the groups. Likewise, the severity of symptoms did not relate to the values of urodynamic variables. CONCLUSIONS: There was no statistically significant relationship between reported severity of symptoms and urodynamic variables, and no relationship between the urodynamic variables used and response to treatment. Therefore, using these values it is not possible to predict a favourable outcome from treatment or to use them to classify disease severity.

Female↗
PubMed1995

Lower urinary tract dysfunction in Parkinson's disease: changes relate to age and not disease.

Lower urinary tract symptoms are frequency report in Parkinson's disease. Whether these are causally related to Parkinson's disease rather than the known effects of age on the urinary tract is unknown. In this study we compared urodynamic data from 1864 women and 357 men with no neurological disease with data from 34 women and 42 men with Parkinson's disease, 96 women and 75 men with cerebrovascular disease and 42 women and 16 men with dementia. We examined isometric and isotonic detrusor contractile function and urethral outflow. Bladder capacity was reduced in both men and women with Parkinson's disease in comparison with patients of similar to that measured in patients without neurological disease and we found no evidence of obstruction in patients with Parkinson's disease. Disease-specific changes were not identified in patients with cerebrovascular disease or dementia. These findings contradict previous reports suggesting specific changes in lower urinary tract function in association with Parkinson's disease.

Aged↗
PubMed1994

An age-related investigation of urinary tract symptoms and infection following urodynamic studies.

One hundred and thirty-nine patients undergoing urodynamic investigation were studied. Urine samples taken at the time of the test and at 72 hours afterwards were cultured and data on symptoms following the test were collected. The overall infection rate was 15.8%. Men and women aged over 70 years were no more likely than younger subjects to become infected. A high residual urine volume was not associated with an increased risk of infection. The only clinical feature associated with infection following the test was an increase in incontinence. These findings were all in contradiction to previous studies on smaller numbers of patients.

Adult↗
PubMed1993

Characterisation of detrusor contractile function in relation to old age.

This report describes an age-related clinical study of detrusor muscle function using urodynamic data obtained from 1391 women and 324 men of different age groups who were free from overt neurological disease and diabetes. Isometric detrusor function during unstable activity was assessed by integrating the calculated force of unstable detrusor activity during filling of the bladder. Isotonic voiding activity was measured by calculating the velocity constant Q*, which reflects the speed of detrusor muscle shortening. In addition, the change in detrusor pressure on initiation of voiding and the post-micturition residual urine volume were recorded. Older patients of both sexes had higher residual urine volumes. Older women showed lower detrusor shortening velocities. There were no age-related differences in isometric detrusor function. Older women showed a tendency for the detrusor contraction to fail on initiation of voiding, whereas older men did not demonstrate this difference. Voiding dysfunction in late life was more marked amongst women and seemed to be related to a failure of isotonic detrusor function with no related changes in isometric function.

Adult↗
PubMed1992

Measurement of oxybutynin and its N-desethyl metabolite in plasma, and its application to pharmacokinetic studies in young, elderly and frail elderly volunteers.

1. A quantitative h.p.l.c. plasma assay for oxybutynin (OB) and its active metabolite, N-desethyl oxybutynin (DEOB) is described. The method is linear with coefficients of variation ranging between 4 and 11.8% for OB and 4.6-9.1% for DEOB over the typical concentration range measured. Minimum detectable levels were 0.5 and 5 ng/ml for OB and DEOB respectively from a 2 ml sample. 2. Pharmacokinetic parameters were obtained after a single oral dose of OB and after administration two or three times daily to frail elderly and elderly volunteer groups respectively. Single dose results were also compared with data from young healthy volunteers. 3. There was a wide range in peak blood levels and high levels of parent drug were matched by high DEOB metabolite levels. Plasma levels on repeated administration were as would be predicted from the single dose kinetics. 4. Area under the plasma time course curve for DEOB metabolite was less than or equal to 5 than that of the parent drug. 5. A trend of increasing peak plasma levels and bioavailability was observed with increasing age and frailty, with the differences more apparent between the active elderly and frail elderly groups than between the active elderly and young volunteers. 6. Results indicate that for frail elderly patients a lower initial starting dose of 2.5 mg OB given two or three times a day may provide adequate therapeutic blood levels of the drug.

Administration, Oral↗
PubMed1991

Terodiline with bladder retraining for treating detrusor instability in elderly people.

OBJECTIVE: To compare terodiline with bladder retraining against placebo with bladder retraining in the treatment of detrusor instability in frail elderly patients. DESIGN: Randomised, double blind, parallel group study. Treatment lasted for six weeks. Frequency of micturition and episodes of incontinence recorded on diary chart by patients. SETTING: Incontinence clinic and a geriatric day hospital at two teaching hospitals. PATIENTS: 37 frail but ambulant patients, mean (range) age 80.4 (70-89) years with urinary frequency and urge incontinence, due to detrusor instability. Two patients withdrew before the first assessment (one in each group) and one could not complete the diary chart (placebo group). INTERVENTIONS: 19 patients received bladder retraining and terodiline 25 mg daily and 18 bladder retraining and placebo. MAIN OUTCOME MEASURES: Change in urinary frequency and number of episodes of incontinence after six weeks' treatment. Patient's subjective evaluation of symptoms. RESULTS: Little difference was found in the results of treatment with terodiline and placebo. The change in episodes of incontinence per 24 hours was no different in the two groups (95% confidence interval -0.6 to 1.2; p = 0.75) and the difference between treatments in the change in frequency of micturition per 24 hours (-0.2) was not significant (-1.1 to 1.2; p = 0.76). Ten patients taking terodiline thought they had improved compared with seven receiving placebo; this difference was not significant. CONCLUSION: Although the number of patients in each group was small and may have been insufficient to detect a drug effect, the possible benefit of terodiline is likely to be small.

Aged↗
PubMed1991

Reducing the leakage of body-worn incontinence pads.

The aim of this research was to evaluate the effect of various absorbent materials (fluff pulp and superabsorbent) on the leakage performance of incontinence pads. A shaped pad-and-pant system was used as the basic design and four pad types made to different specifications were compared using a double-blind technique. Forty-five elderly hospital residents who were incontinent of urine used all four pad types in a randomly allocated order. Data were recorded on more than 5000 pads over a 2-month period. Leakage was reduced by adding a second layer of fluff pulp and, whilst the addition of a superabsorbent material tended to reduce leakage further, we found no clear relationship between the amount of superabsorbent and the reduction of leakage. Other data indicated the importance of securing the pad in place with the appropriate net pants and the leakage rates of pads in relation to the amount of urine they contained. This research suggests that superabsorbent materials have great potential for reducing the leakage rate of incontinence pads but that the way in which they are incorporated into the pad, the amount of fluff pulp and the design of the pad also play an important part.

Absorption↗
PubMed1990

A new comprehensive microcomputer software programme for the urodynamics clinic.

Urodynamic investigation has undoubtedly been greatly refined and facilitated with the use of the modern generation of microcomputers. Manual techniques of data storage, analysis and interpretation are tedious, time consuming and lead to significant observer-dependent transcription errors. The logical solution to this problem is to develop a specifically designed software programme which would operate in conjunction with the microcomputer system integrated in most modern urodynamic apparatus. We describe here our experiences with the development of just such a system.

Computer Systems↗