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The aim of this study was to compare the efficacy of different negative pressure wound therapy (NPWT) devices and NPWT with and without simultaneous irrigation in patients admitted to hospital with moderate and severe foot infections. Ninety patients were randomized in a 12-week prospective, randomized noninferiority trial to compare wound healing in patients with moderate and severe infected foot wounds treated with NPWT after surgery. Inclusion criteria included ABI > 0.5 or toe pressures >30 PVR/mmHg, >18 years of age and exclusion included active Charcot arthropathy, collagen vascular disease, HIV, and hypercoagulable state. We compared two different traditional devices, NPWT-K (KCI, VAC Ulta) and NPWT-C (Cardinal, PRO), and NPWT-I with saline irrigation (Cardinal, PRO). All patients had therapy delivered at 125 mmHg continuous pressure. In patients who received simultaneous saline irrigation (NPWT-I), the administration rate was 15 ml per hour. The primary outcome was the proportion of healed wounds in 12 weeks. Secondary outcomes included surgical wound closure, number of surgeries, length of stay, and time to wound healing. Continuous data was presented as mean ± standard deviation. Analysis of variance was used to compare continuous variables and chi-square to compare dichotomous variables with an alpha of 0.05. There were no differences in outcomes among NPWT-I, NPWT-C, and NPWT-K groups in proportion of healed wounds (63.3%, 50.0%, 46.7% p = 0.39), surgical wound closure (83.3%, 80.0%, 63.3%, p = 0.15), number of surgeries (2.0 ± 0.49, 2.4 ± 0.77, 2.4 ± 0.68, p = 0.06), length of stay (16.3 ± 15.7, 14.7 ± 7.4, 15.3 ± 10.5 days, p = 0.87), time to wound healing (46.2 ± 22.8, 40.9 ± 18.8, 45.9 ± 28.3 days, p = 0.78). We did not identify any significant differences in clinical outcomes or adverse events between patients treated with different NPWT devices or NPWT with and without irrigation.

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As the burden of diabetes continues to grow and treatment standards require careful tracking of wound progress, clinicians increasingly need to rely on technological improvements in wound measurement technologies to track the progress of their treatments. This study aims to determine the accuracy of a new three-dimensional wound measurement (3DWM) device against laser-assisted wound measurement (LAWM) devices and traditional methods of wound measurement. Using several wound models, we demonstrate that the 3DWM device measures wound area, depth and volume similarly to the other methods tested. This is especially apparent when changes in wound measurements were compared between the two devices. Differences between the two technologies were apparent when analysing wound measurement time and measurement repeatability. There was a significantly lower incidence of error in measurements between the 3DWM device and the LAWM device. Finally, the measurement time was significantly faster with the 3DWM device compared to the LAWM device. Together, these data demonstrate that the 3DWM device provides an accurate and reproducible method for measuring changes in wound healing similar to other available technologies. Further, the use of the 3DWM device provides a faster and more consistent measurement, which is critical for clinical application and use.

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BACKGROUND: Previous work has demonstrated the efficacy and safety of fesoterodine in older and younger subjects with overactive bladder (OAB) symptoms. The effect of long-term fesoterodine treatment in different age groups has not been assessed. OBJECTIVE: The aim was to determine the impact of age on the safety, tolerability and efficacy of long-term treatment with fesoterodine 8 mg in subjects with OAB syndrome. METHODS: This was a pooled analysis of two identically designed open-label extensions of 12-week, randomized, double-blind, placebo-controlled studies. The setting was urology and general practice offices. Subjects who participated in the 12-week, double-blind studies and opted to continue long-term, open-label treatment with fesoterodine were included. Subjects were initiated on fesoterodine 8 mg/day at open-label baseline. After 1 month, subjects could elect dose reduction to 4 mg/day and subsequent re-escalation to 8 mg; each was permitted once annually. Maximal duration of open-label treatment ranged from 24 to 36 months. Discontinuations, subject-reported treatment tolerance, and efficacy (3-day diaries) were assessed at open-label baseline and months 1, 4, 8, 12 and 24. RESULTS: A total of 890 subjects were treated (age <45 years, n = 140; 45-64 years, n = 444; 65-74 years, n = 208; ≥75 years, n = 98); 49% continued treatment for ≥ 24 months (age <45 years, 43%; 45-64 years, 54%; 65-74 years, 50%; ≥75 years, 37%). Seventy-seven percent of subjects remained on fesoterodine 8 mg throughout treatment; this rate was highest among subjects aged ≥75 years (age <45 years, 72%; 45-64 years, 77%; 65-74 years, 73%; ≥75 years, 87%). Approximately 80% of continuing subjects were receiving fesoterodine 8 mg at each visit after open-label baseline up to 36 months. No new or unexpected safety signals were observed in any age group. Most subjects reported 'good' or 'excellent' treatment tolerance throughout the study (age <45 years, ≥90%; 45-64 years, ≥93%; 65-74 years, ≥85%; ≥75 years, ≥86%). Dry mouth, the most commonly reported treatment-emergent adverse event, was lowest among subjects aged ≥75 years (age <45 years, 31%; 45-64 years, 30%; 65-74 years, 32%; ≥75 years, 26%). Rates of discontinuation due to dry mouth were low in all age groups. Significant improvements in all diary variables, including urgency urinary incontinence episodes per 24 hours, micturitions per 24 hours, urgency episodes per 24 hours, and mean voided volume per micturition, observed between double-blind baseline and open-label baseline were sustained or increased during open-label treatment in the overall population and all age groups. CONCLUSIONS: Long-term fesoterodine (administered primarily as 8 mg) was well tolerated and associated with sustained improvements in OAB symptoms, irrespective of age.

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OBJECTIVES: • To evaluate the effects of long-term fesoterodine treatment on health-related quality of life (HRQL) and treatment satisfaction in subjects with overactive bladder (OAB) symptoms. • To determine the impact of gender and age on these effects. PATIENTS AND METHODS: • This is a post hoc analysis of data pooled from identically designed open-label extensions of two randomized, double-blind, 12-week fesoterodine studies. • Initial treatment was once-daily fesoterodine 8 mg; subjects had the opportunity to receive open-label fesoterodine for ≥24 months. • After 1 month, subjects could elect dose reduction to 4 mg and subsequent re-escalation to 8 mg; dose reduction and re-escalation were each allowed once annually. • Changes in scores on the King's Health Questionnaire (KHQ), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and a Likert scale evaluating severity of bladder-related problems were assessed at open-label baseline and months 12 and 24; treatment satisfaction was assessed at open-label baseline and at months 4, 12 and 24. RESULTS: • A total of 864 enrolled subjects were included (men, n= 182; women, n= 682; aged <45 years, n= 134; 45-64 years, n= 432; 65-74 years, n= 204; ≥75 years, n= 94); most subjects (77%) who continued treatment maintained the 8-mg dose. • Among subjects in the overall population, there were significant improvements in all KHQ domains, ICIQ-SF scores, and bladder-related problems at open-label baseline vs double-blind baseline (P < 0.05); additional significant improvements were observed at months 12 and 24 vs open-label baseline in all outcomes (P < 0.05) except for the KHQ General Health Perception domain. • When data were stratified by gender or age, significant improvements at open-label baseline vs double-blind baseline were further significantly enhanced or sustained at months 12 and 24 for most KHQ domains, and for ICIQ-SF scores and bladder-related problems for all groups. Women had significantly greater improvements than men in the KHQ Emotion (P= 0.0173) and Severity/Coping (P= 0.0112) domains and ICIQ-SF scores (P= 0.0276) during open-label treatment. Subjects aged <45 years had significantly greater improvement in the Personal Relationships domain compared with those aged 45-64 years (P= 0.0357) and in the Sleep/Energy domain compared with all other groups (all P < 0.02). • Treatment satisfaction was high (≥92%) throughout open-label treatment regardless of gender or age. CONCLUSIONS: • Long-term fesoterodine treatment was associated with sustained improvement in measures of health-related quality of life and bladder-related problems and with high treatment satisfaction in subjects with overactive bladder symptoms. • Effects of gender and age were minimal.

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OBJECTIVE: To evaluate long-term safety, tolerability, and efficacy of fesoterodine for men and women with overactive bladder (OAB) symptoms. RESEARCH DESIGN AND METHODS: This was a post hoc analysis of data pooled from two open-label extensions (NCT00220402, NCT00220376) of double-blind studies. All subjects began open-label treatment with fesoterodine 8 mg once daily, with voluntary dose reduction to 4 mg and re-escalation to 8 mg each permitted once annually. Maximum allowable duration of open-label treatment ranged from 24 to 36 months. MAIN OUTCOME MEASURES: Safety and discontinuations were assessed throughout treatment; subject-reported treatment tolerability and 3-day bladder diaries were evaluated at open-label baseline and months 1, 4, 8, 12, and 24. RESULTS: A total of 185 men and 705 women enrolled; 83 men (45%) and 356 women (50%) continued open-label treatment for ≥ 24 months. Most men (84%) and women (75%) remained on fesoterodine 8 mg throughout open-label treatment. No new or unexpected safety signals were observed. Dry mouth was the most common treatment-emergent adverse event (men, 24%; women, 32%), rates of discontinuation due to dry mouth were low (men, 1%; women, 2%). Most men and women (≥ 91%) reported at least 'good' tolerance. For men and women, statistically significant improvements in urgency urinary incontinence episodes, micturitions, urgency episodes, and mean voided volume per micturition achieved between double-blind baseline and open-label baseline were sustained or further improved through month 24; significant improvements in most OAB symptoms were observed between double-blind baseline and month 24 when subjects were stratified by double-blind treatment (placebo, tolterodine extended release 4 mg, fesoterodine 4 mg, fesoterodine 8 mg). Limitations include the lack of a placebo control and that subjects completing double-blind treatment may have been more likely to tolerate or respond to long-term fesoterodine treatment. CONCLUSIONS: Long-term fesoterodine treatment was well tolerated and associated with sustained improvements in OAB symptoms in men and women.

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OBJECTIVE: To estimate the prevalence and overlap of overactive bladder (OAB), chronic constipation (CC) and faecal incontinence (FI) among a general population sample of adults in the USA. PATIENTS AND METHODS: A cross-sectional internet-based survey of randomly selected panel members who were ≥ 40 years of age was conducted. Participants reported how often they experienced symptoms of OAB, CC and FI using Likert scales and modified Rome III criteria. Analyses were conducted to examine the overall prevalence of OAB, CC and FI in men and women separately and to characterize the extent of overlap between these conditions in participants with OAB vs those without OAB, and those participants with continent vs incontinent OAB. RESULTS: The response rate for the survey was 62.2% and the final sample (N= 2000) included 927 men and 1073 women. The overall prevalence of OAB [defined as a response of ≥ 'sometimes' to urinary urgency (i.e. 'sometimes' or more often) or 'yes' to urinary urgency incontinence (UUI)] was 26.1% in men and 41.2% in women. The overall prevalence of CC was significantly lower in men than in women (15.3 vs 26.3%), but both men and women with OAB were significantly more likely to report CC (22.3 and 35.9% vs 5.7 and 6.7%, respectively, P < 0.0001). The overall prevalence of FI reported 'rarely' or more was 16.7% of men and 21.9% of women. Men and women with OAB were significantly more likely to report FI than those without OAB. FI was also more common in participants with incontinent OAB than in those with continent OAB. Logistic regressions controlling for demographic factors and comorbid conditions suggest that OAB status is a very strong predictor of CC, FI and overlapping CC and FI (odds ratios, range 3.55-7.96). CONCLUSIONS: Chronic constipation, FI and overlapping CC and faecal incontinence occur more frequently in patients with OAB and should be considered when evaluating and treating patients with OAB. These findings suggest a shared pathophysiology among these conditions. Additional study is needed to determine if successful treatment of one or more of these conditions is accompanied by commensurate improvement in symptoms referable to the other organ system.

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OBJECTIVE: To assess the effects of tolterodine extended release (ER) plus behavioral intervention on urgency and other patient-reported outcomes in subjects with overactive bladder (OAB) who were previously dissatisfied with antimuscarinic treatment. METHODS: In this 16-week, multicenter, open-label study, eligible adults (aged > or = 18 y) reported dissatisfaction with their most recent antimuscarinic OAB medication; > or = 8 micturitions and > or = 2 urgency episodes per 24 hours and > or = 1 UUI episode in 5 day bladder diaries; and OAB symptoms for > or = 3 months. Subjects received tolterodine ER plus a behavioral educational handout with verbal reinforcement of behavioral intervention content for 8 weeks. Those satisfied with treatment at week 8 continued with this therapy; those dissatisfied received tolterodine ER plus individualized behavioral intervention (pelvic floor muscle training, tailored behavioral techniques) for 8 weeks. Endpoints were changes from baseline in daytime and nocturnal micturition-related urgency episodes and frequency-urgency sum (a measure of urgency severity and frequency) reported in 5 day bladder diaries at weeks 4, 8, 12, and 16; Patient Perception of Bladder Condition (PPBC), Overactive Bladder Questionnaire (OAB-q), and Urgency Perception Scale (UPS) scores at weeks 8 and 16. RESULTS: Daytime and nocturnal urgency episodes and frequency-urgency sum were significantly reduced at all time points (all p < 0.0001). Significant improvements were also observed in PPBC, OAB-q Symptom Bother and Health-Related Quality of Life, and UPS scores at weeks 8 and 16 (all p < 0.0001). CONCLUSIONS: Patients with OAB who are dissatisfied with antimuscarinic therapy may experience improved treatment outcomes by adding a self-administered behavioral intervention to their drug regimen.

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PURPOSE: To assess contributors to treatment satisfaction with a focused, self-administered behavioral intervention combined with tolterodine extended release (ER) in subjects from an open-label study who had reported dissatisfaction with antimuscarinic treatment for overactive bladder (OAB) before that study. METHODS: Cognitive debriefing interviews were conducted with a convenience sample of 15 participants 7 to 10 months after completing the open-label trial. Reasons that contributed to participants' satisfaction with tolterodine ER treatment combined with behavioral intervention were assessed in the context of their dissatisfaction with prior antimuscarinic treatment. Also assessed were participants' treatment expectations and experiences with specific aspects of study participation and the self-administered behavioral intervention. RESULTS: Among the 15 participants (median age, 57 years; 13 women, 2 men), 12 attributed dissatisfaction with prior antimuscarinics to lack of efficacy. Only 7 participants had positive expectations of tolterodine ER treatment, 5 did not expect it to work, and 3 did not know what to expect. Reasons given for satisfaction with combined treatment were improved OAB symptoms (n = 13), attention of clinic staff (n = 8), review of educational materials on OAB symptoms and treatment (n = 14), and keeping a bladder diary (n = 13). One-third of participants (n = 5) continued to take tolterodine ER for 7 to 10 months after completing the open-label study. CONCLUSION: In addition to antimuscarinic therapy, treatment satisfaction and OAB symptoms may be improved in many patients by using a focused educational pamphlet with verbal reinforcement that increases awareness of OAB causes, treatments, and strategies for improving bladder control, including behavioral interventions and keeping bladder diaries.

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PURPOSE: We assessed the effect of tolterodine extended release plus behavioral intervention on treatment satisfaction and bladder diary variables in patients with overactive bladder who had been previously treated and were dissatisfied with tolterodine or other antimuscarinics. MATERIALS AND METHODS: This 16-week, multicenter, open label study included eligible patients 18 years old or older who reported overactive bladder symptoms 3 months or greater in duration, 8 or greater micturitions and 2 or greater urgency related micturitions per 24 hours, and 1 or greater urgency urinary incontinence episodes in a 5-day bladder diary at baseline as well as dissatisfaction with prior antimuscarinic medication. Patients received tolterodine extended release plus self-administered behavioral intervention, consisting of an educational pamphlet with verbal reinforcement, for 8 weeks. Satisfied patients continued with this therapy and dissatisfied patients received tolterodine extended release plus individualized behavioral intervention, consisting of in-depth interaction with a clinician to refine behavioral techniques, for 8 weeks thereafter. Patients rated treatment satisfaction at weeks 8 and 16, and completed a 5-day bladder diary at weeks 4, 8, 12 and 16, respectively. RESULTS: At weeks 8 and 16, 346 and 357 patients or 91% of the total cohort reported being at least a little satisfied with tolterodine extended release plus behavioral intervention, including 201 (53%) and 252 (64%), respectively, who were very satisfied. Of the 33 patients who were dissatisfied at week 8, 25 (76%) reported treatment satisfaction at week 16 after individualized behavioral intervention. Compared with baseline all bladder diary variables were significantly improved by week 4 (p <0.0001). Patients who were dissatisfied with prior tolterodine or other antimuscarinic treatment reported similar results. CONCLUSIONS: Tolterodine extended release plus behavioral intervention resulted in high treatment satisfaction and improved bladder diary variables in patients who had previously been treated and were dissatisfied with tolterodine or other antimuscarinics.

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OBJECTIVE: To review the efficacy and safety of fesoterodine, a new antimuscarinic for treating overactive bladder (OAB) symptoms. METHODS: Review of efficacy and safety data from the pivotal phase 3 trials of fesoterodine for the treatment of OAB. Although there were a number of additional end points, they were not included in the US prescribing information for fesoterodine and thus are not included in this article. RESULTS: OAB is a chronic condition affecting both men and women. The principal symptom is urgency, with or without urgency incontinence, with some patients experiencing increased daytime frequency and nocturia. In two 12-week, randomized, double-blind, phase 3 trials, fesoterodine 4 and 8 mg administered once daily were significantly better than placebo in alleviating OAB symptoms, as determined by changes in bladder diary variables. Both doses of fesoterodine were well tolerated. CONCLUSIONS: Fesoterodine is an efficacious, well-tolerated treatment for OAB.

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