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Biomedical subjects

Paul Abrams

Publications and source records attributed to Paul Abrams.

At least 37 records · Page 2Linked to original sources

Impact of surgical treatment on nocturia in men with benign prostatic obstruction.

OBJECTIVES: To validate the International Consultation on Incontinence Nocturia Quality-of-life (NQoL) questionnaire in Italian (IT-NQoL) and use it to evaluate the impact of surgical treatment on nocturia in men with lower urinary tract symptoms related to benign prostatic obstruction (LUTS/BPO). PATIENTS AND METHODS: All men attending one urological unit between November 2004 and April 2005 were enrolled in the study. They were assessed in two groups; those with and with no LUTS/BPO. An Italian translation of the NQoL was devised, and patients then completed this and validated Italian versions of the International Prostate System Score (IPSS), the Pittsburg Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS). Clinical, laboratory and instrumental data from each patient were recorded. The patients with LUTS/BPO then had surgical treatment, and 6 months later those with LUTS/BPO were asked to complete all the questionnaires again to evaluate the test sensitivity to change. RESULTS: Of the 109 patients enrolled in the study, 61 were affected by LUTS/BPO and 48 were not. Cronbach's alpha for the IT-NQoL was 0.943 (95% confidence interval, CI, 0.922-0.959; P < 0.001) and the intra-class correlation coefficient was 0.999 (95% CI 0.998-0.999; P < 0.001) for the total IT-NQoL score. The correlation between the test and the re-test was statistically significant (P < 0.001; r = 0.999) for all items. The mean (sd) IT-NQoL score showed an improvement in QoL from before, at 23.4 (10.1), to after treatment, at 3.09 (2.48) (P < 0.001). In the LUTS/BPO group, the IT-NQoL correlated with the number of times when waking to urinate (Pearson's coefficient 0.80, P < 0.001). There was also a correlation for ESS (0.796) and for the seven PSQI subscales (0.614, both P < 0.001). The decrease in sleep quality, duration and efficiency resulted in an increase in daytime sleepiness (r = 0.639, 0.642). At the 6-month follow-up, all questionnaire results were statistically different from those before treatment. CONCLUSIONS: The IT-NQoL is the first validated translation of the primary instrument into another language. This version is easy to use and has the same characteristic validity as the English version. Using the IT-NQoL showed that surgical treatment determines a decrease in the nocturia rate and an increase in QoL. There was also a significant increase in QoL after treatment as assessed by all the other questionnaires.

Aged↗

Pharmacological management of women with mixed urinary incontinence.

Mixed urinary incontinence (MUI) is a symptomatic diagnosis. It is defined by the International Continence Society as the complaint of involuntary leakage associated with urgency and also with exertion, effort, sneezing and coughing. A search of medical databases revealed that only a small number of limited studies that assess the prevalence, epidemiology and treatment of MUI have been conducted. Most studies have looked separately at either stress urinary incontinence or urgency urinary incontinence. Thus, management of MUI involves a combination of treatments for both stress and urgency incontinence, but should concentrate initially on the most bothersome and/or predominant symptom. Initial management includes an accurate history and examination, which is supplemented by a bladder diary and quality-of-life questionnaire. Once a preliminary diagnosis is established, first-line therapy includes patient education and lifestyle interventions, such as weight loss. This is supplemented by pelvic floor muscle training and bladder training, which help with both components of MUI. Oral pharmacotherapy often acts synergistically with the previous treatments; however, only very few randomised, placebo-controlled trials have looked at the effects of pharmacotherapy on MUI. The two main classes of drugs are the antimuscarinics, which are effective in urgency incontinence, and the serotonin-norepinephrine re-uptake inhibitors, which are effective in stress incontinence. Combination of these two drug classes is a feasible option but has not been tested in any trials to date. Should these treatments fail, then patients should be referred for cystometry to confirm the diagnosis. Treatment options available following urodynamics include invasive minor and major surgical procedures, which either treat the stress or urgency component of MUI but not both. Surgical procedures carry the risk of infection, haemorrhage and failure.

Adrenergic Agents↗

Solifenacin is effective for the treatment of OAB dry patients: a pooled analysis.

OBJECTIVE: The aim of this analysis was to determine the effects of solifenacin in patients considered overactive bladder (OAB) dry at baseline. METHODS: This was a pooled analysis of 4 randomized, placebo-controlled 12-week, phase 3 studies. Patients received placebo or solifenacin 10 mg once daily (2 studies), or placebo or solifenacin 5 mg or 10 mg once daily (2 studies). A subgroup of patients without incontinence at baseline was identified from a 3-day diary. Mean changes from baseline to endpoint for urgency episodes, micturition, frequency and nocturia episodes per 24 hours, and volume voided/micturition were evaluated. The proportion of patients with normalization of micturition frequency (<8 micturitions), resolution of urgency, or resolution of nocturia at endpoint was also determined. RESULTS: Of 2848 evaluable patients treated with placebo or solifenacin, 975 (34%) were OAB dry at baseline. Solifenacin 5 mg and 10 mg were significantly (p < 0.001) more effective than placebo for improving urgency, micturition frequency, and volume voided. In addition, solifenacin 10mg was significantly (p < 0.01) more effective than placebo for improving nocturia. Resolution of urgency occurred significantly (p < 0.05) more often with solifenacin 5 mg (37%) and 10 mg (33%) than with placebo (25%). Significantly (p < 0.01) more OAB dry patients had normalization of micturition frequency with solifenacin 5 mg (29%) and 10 mg (35%) compared with placebo (19%). Resolution of nocturia occurred in 14%, 21%, and 13% of patients treated with solifenacin 5mg, solifenacin 10 mg, and placebo, respectively (p < 0.01 for solifenacin 10 mg versus placebo). CONCLUSION: Solifenacin significantly improved urgency, frequency, and nocturia symptoms and increased volume voided in OAB dry patients.

Adult↗

Future directions in pelvic neuromodulation.

In view of the success of sacral nerve stimulation, new lines of research are enabling us to do more selective stimulation of the innervation of the bladder at more peripheral sites,such as pudendal nerve stimulation, and with the use of less invasive devices, such as Bion and other in situ implantable devices. The aim of this research is to determine ifa less invasive, more selective stimulation or an event-driven (detrusor overactivity ora desire for micturition) stimulus would allow for a more improved and durable response.

Botulinum Toxins, Type A↗

The natural history of lower urinary tract dysfunction in men: minimum 10-year urodynamic followup of transurethral resection of prostate for bladder outlet obstruction.

PURPOSE: Despite long-term symptomatic and uroflowmetry studies following transurethral prostate resection (TURP) there are sparse pressure flow data. Consequently there is minimal information to account for the long-term symptomatic failure and flow rate decrease seen with time following early improvements after surgery. MATERIALS AND METHODS: Men older than 45 years who were investigated at our department between 1972 and 1986, diagnosed with bladder outlet obstruction and elected surgical intervention were invited for repeat symptomatic and urodynamic assessment. Identical methods were used, allowing direct comparison of results. RESULTS: A total of 1,068 men were initially diagnosed with bladder outlet obstruction, of whom 428 (40%) died in the interim. Of the men who were followed 217 underwent TURP with a mean followup since surgery of 13.0 years. A significant, sustained decrease in the majority of symptoms and improvements of urodynamic parameters was seen. Long-term symptomatic failure and decreased flow rate were principally associated with detrusor under activity (DUA) rather than obstruction. Presentation predictive factors for the future development of DUA were decreased detrusor contractility and a lesser degree of obstruction. CONCLUSIONS: This unique long-term study provides valuable information on surgically treated bladder outlet obstruction. The association of long-term failure following surgery with DUA emphasizes the importance of pressure flow studies before repeat surgery. However, our faith in the long-term efficacy of TURP is justified.

Age Distribution↗

A pooled analysis of three phase III studies to investigate the efficacy, tolerability and safety of darifenacin, a muscarinic M3 selective receptor antagonist, in the treatment of overactive bladder.

OBJECTIVE: To evaluate the efficacy, tolerability and safety of darifenacin, a muscarinic M3 selective receptor antagonist (M3 SRA), from an analysis of pooled data from three phase III, multicentre, double-blind clinical trials in patients with overactive bladder (OAB). PATIENTS AND METHODS: After a 4-week washout/run-in period, 1059 adults (85% women) with symptoms of OAB (frequency and urgency with urge incontinence) for > or = 6 months were randomized to once-daily oral treatment with darifenacin (7.5 mg, 337; or 15 mg, 334) or matching placebo (388) for 12 weeks. Efficacy was evaluated using electronic patient diaries that recorded incontinence episodes (including those resulting in a change of clothing or pads), frequency and severity of urgency, voiding frequency, and bladder capacity (volume voided). Safety was evaluated by analysis of adverse events (AEs), withdrawal rates and laboratory tests. RESULTS: Relative to baseline, 12 weeks of treatment with darifenacin resulted in a significant reduction in the median (% change, interquartile range) number of incontinence episodes per week; 7.5 mg (-8.8, -68.4%, -15.1 to -4.4); 15 mg; (-10.6, -76.8%, -17.3 to -5.8: both P < 0.01 vs placebo). There was a significant dose-response trend in each study for which darifenacin 7.5 and 15 mg were evaluated (P < 0.01). There were also significant decreases in the frequency and severity of urgency, voiding frequency, and number of significant leaks (incontinence episodes resulting in a change of clothing or pads; both P < or = 0.001 vs placebo), together with an increase in bladder capacity (both P < 0.01 vs placebo). Darifenacin was well tolerated; the most common AEs were dry mouth and constipation, although together these resulted in few discontinuations (darifenacin 7.5 mg 0.6% of patients; 15 mg 2.1%; placebo 0.3%). The incidence of peripheral/central nervous system and cardiovascular AEs were comparable with those on placebo. CONCLUSIONS: Darifenacin (7.5 and 15 mg once daily) is effective in the treatment of patients with OAB. As predicted by its M3 selectivity and associated M1/M2-sparing profile, darifenacin was well tolerated with no central nervous system or cardiovascular safety concerns.

Adult↗

The natural history of lower urinary tract dysfunction in men: minimum 10-year urodynamic follow-up of untreated bladder outlet obstruction.

OBJECTIVES: To assess the long-term outcomes of untreated bladder outlet obstruction (BOO), assuming that, if there is little or no deterioration, a conservative approach to management is justified, as there is little information on the natural history of untreated BOO and lower urinary tract symptoms (LUTS) in men, and studies to date suggest that neither BOO nor LUTS inevitably progress to a stage at which prostatectomy is required. PATIENTS AND METHODS: Men aged >45 years who were investigated in our department between 1972 and 1986, diagnosed with BOO, and who initially opted for no specific treatment were invited for repeat symptomatic and urodynamic evaluation. Identical methods of assessment were used, allowing results to be compared directly. RESULTS: In all, 1068 men were initially diagnosed with BOO; 428 (40%) of these died. Of the 170 men who initially opted for a conservative approach and attended for repeat assessment, 141 (83%) remained untreated, with a mean follow-up of 13.9 years. The only significant urodynamic changes were a reduction in detrusor contractility and an increased prevalence of detrusor overactivity. Most patients reported no change in their symptoms but a significant minority experienced a gradual deterioration. Of the 29 men in whom the conservative approach failed, 22 proceeded to surgery for LUTS, and seven for acute urinary retention. CONCLUSIONS: Patients with untreated BOO do not significantly deteriorate urodynamically in the long term, with only a minority deteriorating symptomatically. These findings justify a conservative approach to men with LUTS associated with BOO.

Aged↗

The natural history of lower urinary tract dysfunction in men: minimum 10-year urodynamic follow-up of untreated detrusor underactivity.

OBJECTIVES: To assess the long-term symptomatic and urodynamic outcomes of men with untreated detrusor underactivity (DUA) as there has been little long-term follow-up information on men with DUA, a cause of lower urinary tract symptoms (LUTS) in a significant minority of men. PATIENTS AND METHODS: Neurologically intact men aged > 18 years who were investigated in our department between 1972 and 1986, diagnosed with DUA, and who initially opted for no specific treatment were invited for a repeat symptomatic and urodynamic evaluation. Identical methods of assessment were used, allowing results to be compared directly. RESULTS: In all, 224 men were initially diagnosed with DUA; 87 (39%) of these died. Of the 69 men who initially opted for a conservative approach and attended for repeat assessment, 58 (84%) remained untreated, with a mean follow-up of 13.6 years. There were no significant changes in symptoms over the follow-up. The only significant urodynamic finding was an increase in the proportion of patients with detrusor overactivity, but with no apparent worsening of chronic retention. Of the 11 men in who failed the conservative approach, eight proceeded to surgery for LUTS, and three for acute urinary retention. CONCLUSIONS: These results provide important information on the natural history of DUA. In men with DUA presenting with LUTS there are few symptomatic and urodynamic changes with time.

Adult↗

ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence.

AIMS: To develop and evaluate the International Consultation on Incontinence Questionnaire (ICIQ), a new questionnaire to assess urinary incontinence and its impact on quality of life (QoL). METHODS: A developmental version of the questionnaire was produced following systematic literature review and views of an expert committee and patients. Several studies were undertaken to evaluate the psychometric properties of the questionnaire, including content, construct and convergent validity, reliability and sensitivity to change. RESULTS: The ICIQ was easily completed, with low levels of missing data (mean 1.6%). It was able to discriminate among different groups of individuals, indicating good construct validity. Convergent validity was acceptable, with most items demonstrating 'moderate' to 'strong' agreement with other questionnaires. Reliability was good, with 'moderate' to 'very good' stability in test-retest analysis and a Cronbach's alpha of 0.95. Items identified statistically significant reductions in symptoms from baseline following surgical and conservative treatment. Item reduction techniques were used to determine the final version and scoring scheme, which also demonstrated good psychometric properties. CONCLUSIONS: The final ICIQ comprises three scored items and an unscored self-diagnostic item. It allows the assessment of the prevalence, frequency, and perceived cause of urinary incontinence, and its impact on everyday life. The ICIQ is a brief and robust questionnaire that will be of use in outcomes and epidemiological research as well as routine clinical practice.

Adult↗

A scored form of the Bristol Female Lower Urinary Tract Symptoms questionnaire: data from a randomized controlled trial of surgery for women with stress incontinence.

OBJECTIVE: Lower urinary tract symptoms are common among older women. The Bristol Female Lower Urinary Tract Symptoms (BFLUTS) questionnaire was designed to assess a wide range of symptoms, including incontinence, and impact on sexual function and quality of life. This paper describes development and validation of a scored form BFLUTS questionnaire. STUDY DESIGN: Baseline and 6-month follow-up data from a randomized trial compared tension-free vaginal tape with colposuspension for 344 women with urodynamically proven stress incontinence. Problematic and responsive items were identified and subjected to factor analysis to develop a scoring system. RESULTS: Three domains were identified to assess symptoms: incontinence (5 items); voiding (3 items); and filling (4 items); with additional subscales for sexual function (2 items) and quality of life (5 items). All scales have simple additive scores. CONCLUSION: A scored form of the BFLUTS questionnaire is now available and should be useful in research and clinical practice in urology and gynecology.

Factor Analysis, Statistical↗

Development and validation of a quality-of-life measure for men with nocturia.

OBJECTIVES: To develop and assess the psychometric properties of a short self-report nocturia-specific Quality-of-Life (QOL) questionnaire. METHODS: The Nocturia Quality-of-Life questionnaire (N-QOL) was developed using focus group interviews with men experiencing nocturia. To refine it further and psychometrically validate the questionnaire, 107 men with nocturia (from four urology clinics in the United Kingdom) completed the pilot N-QOL, along with measures of health status and sleep quality. To assess reproducibility, men from one clinic completed the pilot N-QOL again at 1 week. RESULTS: After standard item reduction analyses, 18 items were dropped from the pilot questionnaire. The psychometric properties of the remaining 13-item instrument were tested in accordance with standard criteria. Factor analysis identified two subscales, sleep/energy and bother/concern, loading at 0.5 and greater. The N-QOL overall score and subscales proved to be internally consistent (alpha = 0.84 to 0.90) and reproducible (intraclass correlation coefficient = 0.74 to 0.82). N-QOL scores correlated with sleep quality (P <0.01) as measured by the Pittsburgh Sleep Quality Index and energy/vitality and social functioning (P <0.01) as measured by the SF-36 Health Survey, demonstrating good convergent validity. The N-QOL also demonstrated statistically significant differences between the scores of those experiencing one, two, and three or more episodes of nocturia on an average night, indicating excellent discriminant validity. CONCLUSIONS: These analyses provide support for the psychometric validity of the N-QOL for use in a male population with nocturia.

Adult↗