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1.
Anna-Lena Wennberg Ulla Molander Magnus Fall Christer Edlund Ralph Peeker Ian Milsom 《European urology》2009
Background
Female urinary incontinence (UI), overactive bladder (OAB), and other lower urinary tract symptoms (LUTS) are highly prevalent conditions with a profound influence on well-being and quality of life. There are a few studies describing progression as well as remission, in the short term, of UI in the general population as well as in selected groups; at present, there are very few population-based studies describing the natural course of other LUTS in the same women, and there are no long-term longitudinal studies.Objective
To describe the prevalence of UI, OAB, and other LUTS in the same women studied prospectively over time and, thus, to assess possible progression or regression.Design, setting, and participants
A longitudinal population-based study was performed in one primary health care district in the city of Gothenburg, Sweden. The participants were a sample of women aged ≥20 yr who were randomly selected from the Swedish National Population Register, assessed in 1991 (n = 2911), and available for reassessment in 2007 (n = 1408).Methods
A self-administered postal questionnaire regarding UI, OAB, and other LUTS was returned by 77% of the contacted women in 1991. The same women who responded in 1991 and who were still alive and available in the Swedish National Population Register 16 yr later were reassessed using a similar self-administered postal questionnaire.Results and limitations
In 2007, 1081 of the available 1408 women responded to the questionnaire (77%). The overall prevalence of UI, OAB, nocturia, and daytime micturition frequency of eight or more times per day increased by 13%, 9%, 20% (p < 0.001), and 3% (p < 0.05), respectively, from 1991 to 2007. The incidence of UI and OAB were 21% and 20%, respectively, and the corresponding remission rates were 34% and 43%, respectively. Women with OAB symptoms were classified as OAB dry or OAB wet, depending on the presence or absence of concomitant UI. The prevalence of OAB dry did not differ between the two assessment occasions (11% and 10%, respectively), but the prevalence of OAB wet increased from 6% to 16% (p < 0.001).Conclusions
UI and other LUTS constitute dynamic conditions. In this study, there was a marked overall increase in the prevalence of UI, OAB, and nocturia in the same women from 1991 to 2007. Both incidence and remission of most symptoms were considerable. 相似文献2.
Antonia Centemero Lorenzo Rigatti Donatella Giraudo Massimo Lazzeri Giovanni Lughezzani Daniela Zugna Francesco Montorsi Patrizio Rigatti Giorgio Guazzoni 《European urology》2010
Background
Despite improvements in surgical techniques, urinary incontinence (UI) is not uncommon after radical prostatectomy (RP), and it may dramatically worsen quality of life (QoL).Objective
To determine the benefit of starting pelvic floor muscle exercise (PFME) 30 d before RP and of continuing PFME postoperatively for early recovery of continence.Design, setting, and participants
A randomised, prospective study was designed. Men with localised prostate cancer (PCa) who underwent an open radical retropubic prostatectomy (RRP) at our department of urology were included.Intervention
Patients were randomised to start PFME preoperatively and continue postoperatively (active group: A) or to start PFME postoperatively alone (control group: B).Measurements
The primary outcome measure was self-reported continence after surgery. Secondary outcome measures were assessed by degree of UI based on a 24-h pad test and QoL instruments (International Continence Society [ICS] male short form [SF]).Results and limitations
Of 143 men evaluated for the study, 118 were randomised either to start PFME preoperatively and continue postoperatively (group A; n = 59) or to start postoperative PFME (group B; n = 59). After 1 mo, 44.1% (26 of 59) of patients were continent in group A, while 20.3% (12 of 59) were continent in group B (p = 0.018). At 3 mo, 59.3% (35 of 59) and 37.3% (22 of 59) patients were continent in group A and group B, respectively (p = 0.028). The ICS male SF mean score showed better results in group A than in group B patients at both 1 mo (14.6 vs 18.3) and 3 mo (8.1 vs 12.2) after RP (p = 0.002). In age-adjusted logistic regression analyses, patients who performed preoperative PFME had a 0.41-fold lower risk of being incontinent 1 mo after RP and a 0.38-fold lower risk of being incontinent 3 mo after RP (p ≤ 0.001).Conclusions
Preoperative PFME may improve early continence and QoL outcomes after RP. Further studies are needed to corroborate our results. 相似文献3.
Background
Botulinum toxin type A (BoNTA) has been reported to be effective for treatment of patients with neurogenic detrusor overactivity (NDO) refractory to anticholinergic agents. However, in most of the studies, the efficacy was associated with concomitant use of anticholinergics.Objective
To evaluate the efficacy and tolerability of BoNTA and compare two different doses in patients with NDO without concomitant anticholinergics.Design, setting, and participants
Between 2004 and 2006, adults with NDO refractory to anticholinergics or discontinued anticholinergics due to adverse events or contraindications from four different French clinical centres were included in a prospective, randomised, double-blind, comparative trial. Inclusion criteria were urinary incontinence (UI) resulting from NDO that could not be managed with anticholinergics. Patients with bladder cancer, lithiasis, or urinary infection were excluded.Intervention
Patients were randomised to receive an intradetrusor injection of 500 U or 750 U of BoNTA.Measurements
The initial evaluation (ie, clinical and urodynamic variables and quality of life [QoL]) was repeated at days 30, 90, 180, and 360. Primary outcome was complete continence rate at day 30. Secondary outcomes were cumulative incontinence rate, reappearance of leakages, pad usage, urodynamics, and QoL.Results and limitations
Seventy-seven patients received 500 U (n = 39) or 750 U (n = 38) of BoNTA and were included in the full analysis set for efficacy analysis. Complete continence at day 30 was observed in 22 patients (56.4%) and 28 patients (73.7%) receiving 500 U or 750 U of BoNTA, respectively (p = 0.056; one-sided χ2 test to compare to α = 0.025). The median delay in the reappearance of leakages was 168 d. Monotherapy of BoNTA significantly improved UI in patients with NDO. Although there was a trend towards a greater improvement with 750 U of BoNTA, no statistically significant differences in terms of clinical and urodynamic variables and QoL were found between the treatment groups. Tolerability was excellent and equivalent for both doses.Conclusions
Monotherapy of BoNTA at Dysport (Ipsen, Brisbane, CA, USA) doses of 500 U or 750 U seems to be effective and well tolerated in patients with NDO. 相似文献4.
Christopher Chapple Karl-Dietrich Sievert Scott MacDiarmid Vik Khullar Piotr Radziszewski Christopher Nardo Catherine Thompson Jihao Zhou Cornelia Haag-Molkenteller 《European urology》2013
Background
Overactive bladder (OAB) syndrome with urinary incontinence (UI) is prevalent in the population and impairs health-related quality of life (HRQOL).Objective
To assess the impact on efficacy, safety, and HRQOL of onabotulinumtoxinA (BOTOX®, Allergan, Inc.) treatment in patients with OAB with UI.Design, setting, and participants
This pivotal, multicentre, double-blind, randomised, placebo-controlled, phase 3 study enrolled patients with idiopathic OAB with ≥3 urgency UI episodes over 3 d and ≥8 micturitions per day who were inadequately managed by anticholinergics.Intervention
OnabotulinumtoxinA at a 100 U dose (n = 277) or placebo (n = 271), administered as 20 intradetrusor injections of 0.5 ml.Outcome measurements and statistical analysis
Co–primary end points were change from baseline in the number of UI episodes per day and proportion of patients reporting positive treatment response on the treatment benefit scale (TBS) at week 12. Additional end points included other OAB symptoms (episodes of urinary urgency incontinence, micturition, urgency, and nocturia) and HRQOL (Incontinence Quality of Life [I-QOL], King's Health Questionnaire [KHQ]). Safety assessments included adverse events (AEs), postvoid residual (PVR) urine volume, and initiation of clean intermittent catheterisation (CIC).Results and limitations
OnabotulinumtoxinA significantly decreased UI episodes per day at week 12 (−2.95 for onabotulinumtoxinA versus −1.03 for placebo; p < 0.001). Reductions from baseline in all other OAB symptoms were also significantly greater following onabotulinumtoxinA compared with placebo (p ≤ 0.01). Patients perceived a significant improvement in their condition, as measured by patients with a positive treatment response on the TBS (62.8% for onabotulinumtoxinA versus 26.8% for placebo; p < 0.001). Clinically meaningful improvements from baseline in all I-QOL and KHQ multi-item domains (p < 0.001 versus placebo) indicated positive impact on HRQOL. AEs were mainly localised to the urinary tract. Mean PVR was higher in the onabotulinumtoxinA group (46.9 ml versus 10.1 ml at week 2; p < 0.001); 6.9% of onabotulinumtoxinA patients versus 0.7% of placebo patients initiated CIC.Conclusions
OnabotulinumtoxinA 100 U was well tolerated and demonstrated significant and clinically relevant improvements in all OAB symptoms, patient-reported benefit, and HRQOL in patients inadequately managed by anticholinergics.Trial registration
ClinicalTrials.gov: NCT00910520. 相似文献5.
Apostolos Apostolidis Paraskevi-Sofia Kirana Gretchen Chiu Carol Link Marina Tsiouprou Dimitrios Hatzichristou 《European urology》2009
Background
Few comparisons have been made of health care seeking behaviour for lower urinary tract symptoms (LUTS) between men and women, as well as trends across age groups.Objective
To investigate the bother from LUTS and effect on health care seeking in both men and women of different age groups and in comparison between the two genders.Design, setting, and participants
A representative cross section of each of 13 clinics of a general academic hospital, with equal numbers of subjects recruited in each of six design cells that were defined by age (18–40, 41–60, 61–80 yr) and gender.Intervention
A 2-h in-person interview, conducted by a trained psychologist/interviewer in a clinic office.Measurements
Severity of LUTS was measured by the International Prostate Symptom Score (IPSS). Treatment seeking was measured by a single item. A bother question was modified to assess overall bother. Impact on quality of life (QoL) was measured by the IPSS QoL question.Results and limitations
The final study sample comprised 415 patients. More women than men reported the presence of LUTS (85.5% vs 75.2%; p = 0.01). LUTS were more bothersome in women (25.4% of women vs 17.6% of men with bother “some” or “a lot”; p = 0.02). Severity of LUTS increased with age in both genders (men: p < 0.001; women: p = 0.03). Bother from LUTS increased as severity of symptoms increased in both genders (p < 0.001) but was associated with age only in men (p < 0.001). QoL showed similar results as bother. Although men and women had equal prevalence of treatment seeking (27.9% vs 23.7%; p = 0.40), men, but not women, were more likely to seek treatment as age (p < 0.01) and severity of LUTS (p < 0.001) increased. In multivariate logistic regressions, only bother from LUTS was associated with treatment seeking in women, compared with bother, age, and the presence of voiding symptoms in men.Conclusions
In our hospital-based sample, differences in LUTS frequency, bother, and health care seeking profiles between men and women suggest a different perception and response to LUTS between the two genders. 相似文献6.
Alessandro Palmieri Ciro ImbimboNicola Longo Ferdinando FuscoPaolo Verze Francesco MangiapiaMassimiliano Creta Vincenzo Mirone 《European urology》2009
Background
Extracorporeal shock wave therapy (ESWT) is a conservative therapy for patients with Peyronie's disease (PD).Objective
To investigate the effects of ESWT in patients with PD.Design, setting, and participants
One hundred patients with a history of PD not >12 mo who had not had previous PD-related treatments were enrolled in a prospective, randomized, double-blind, placebo-controlled study. Patients were randomly allocated to either ESWT (n = 50) or placebo (n = 50). Erectile function (EF), pain during erection, plaque size, penile curvature, and quality of life (QoL) were assessed at baseline, at 12 wk, and at 24 wk follow-up.Intervention
Four weekly treatment sessions were administered. Each ESWT session consisted of 2000 focused shock waves. For the placebo group, a nonfunctioning transducer was employed.Measurements
EF was evaluated with the shortened version of the International Index of Erectile Function (IIEF-5), pain was evaluated with a visual analog scale (VAS; 0–10), plaque size was measured in cm2, and penile curvature was measured in degrees.Results and limitations
After 12 wk, mean VAS score, mean IIEF-5 score, and mean QoL score ameliorated significantly in patients receiving ESWT. Mean plaque size and mean curvature degree were unchanged in the ESWT group, while a slight increase was reported in the placebo group (p-value not significant vs baseline). After 24 wk, mean IIEF-5 score and mean QoL score were stable in the ESWT group, while mean VAS score was significantly lower when compared with baseline in both groups. Interestingly, after 24 wk, mean plaque size and mean curvature degree were significantly higher in the placebo group when compared with both baseline and ESWT values. The main limitations were that the QoL questionnaire was not validated, ED was not etiologically characterized, and inclusion criteria were restricted.Conclusions
In patients with PD, ESWT leads to pain resolution and ameliorates both EF and QoL. 相似文献7.
Background
A significant proportion of patients develop urinary incontinence early after radical prostatectomy. Posterior reconstruction of supporting tissues has been found to reduce incontinence in open and conventional laparoscopic prostatectomy series.Objective
To investigate whether our version of a posterior musculofascial reconstruction will reduce early incontinence and have a beneficial effect on patients’ quality of life (QoL).Design, setting, and participants
One hundred seven consecutive patients undergoing primary robot-assisted radical laparoscopic prostatectomy (RALP) performed by a single surgeon at one tertiary referral oncology institution were alternately assigned (not randomised) to intervention (n = 53) or control groups (n = 54).Surgical procedure
RALP with median fibrous raphe reconstruction (MFRR) followed by formation of the urethrovesical anastomosis (intervention group) versus standard anastomosis without posterior reconstruction (control group).Measurements
Measurements included incontinence at baseline and 3-mo intervals; QoL as measured by a simple questionnaire, the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life–Core 30 (QLQ-C30), and Prostate Cancer Module (PR25) questionnaires preoperatively and at 6 mo postprocedure; tumour characteristics; operative time; fascial preservation score; duration of catheterisation; and anastomotic leakage on cystogram.Results and limitations
For intervention and control groups respectively, mean catheter duration was 11.74 d and 12.74 d (p = 0.451); leakage on cystogram was present in six and eight cases (p = 0.28); and incontinence (any involuntary urine loss) at 3 mo was 75% and 69% (p = 0.391) and at 6 mo was 51% and 43% (p = 0.686). Urinary retention occurred only in one case (control group). The percentage of cases returning to baseline in all QoL domains (except insomnia) was similar at 6 mo between the two groups. Short follow-up, lack of blinding, and probable small differences in our method of MFRR performed compared with other studies were identified as significant limitations.Conclusions
No significant difference in any of the analysed outcome measures was observed. Posterior reconstruction of the musculofascial complex does not appear to improve early urinary incontinence after RALP. 相似文献8.
Lara Bellardita Tiziana Rancati Maria Francesca Alvisi Daniela Villani Tiziana Magnani Cristina Marenghi Nicola Nicolai Giuseppe Procopio Sergio Villa Roberto Salvioni Riccardo Valdagni 《European urology》2013
Background
Active surveillance (AS) is emerging as an alternative approach to limit the risk of overtreatment and impairment of quality of life (QoL) in patients with low-risk localised prostate cancer. Although most patients report high levels of QoL, some men may be distressed by the idea of living with untreated cancer.Objective
To identify factors associated with poor QoL during AS.Design, setting, and participants
Between September 2007 and March 2012, 103 patients participated in the Prostate Cancer Research International Active Surveillance (PRIAS) QoL study. Mental health (Symptom Checklist-90), demographic, clinical, and decisional data were assessed at entrance in AS. Health-related QoL (HRQoL) Functional Assessment of Cancer Therapy-Prostate version and Mini-Mental Adjustment to Cancer outcomes were assessed after 10 mo of AS.Outcome measurements and statistical analysis
Multivariate logistic regression models were used to identify predictors of low (<25th percentile) HRQoL, adjustment to cancer, and a global QoL index at 10 mo after enrolment.Results and limitations
The mean age of the study patients was 67 yr (standard deviation: ±7 yr). Lack of partner (odds ratio [OR]: 0.08; p = 0.009) and impaired mental health (OR: 1.2, p = 0.1) were associated with low HRQoL (p = 0.006; area under the curve [AUC]: 0.72). The maladaptive adjustment to cancer (p = 0.047; AUC: 0.60) could be predicted by recent diagnosis (OR: 3.3; p = 0.072). Poor global QoL (overall p = 0.02; AUC: 0.85) was predicted by impaired mental health (OR: 1.16; p = 0.070) and time from diagnosis to enrolment in AS <5 mo (OR: 5.52; p = 0.009). Influence of different physicians on the choice of AS (OR: 0.17; p = 0.044), presence of a partner (OR: 0.22; p = 0.065), and diagnostic biopsy with >18 core specimens (OR: 0.89; p = 0.029) were predictors of better QoL. Limitations of this study were the small sample size and the lack of a control group.Conclusions
Factors predicting poor QoL were lack of a partner, impaired mental health, recent diagnosis, influence of clinicians and lower number of core samples taken at diagnostic biopsy. Educational support from physicians and emotional/social support should be promoted in some cases to prevent poor QoL. 相似文献9.
Russell Szmulewitz Supriya MohileEdwin Posadas Rangesh KunnavakkamTheodore Karrison Elizabeth ManchenWalter M. Stadler 《European urology》2009
Background
Even in castration-resistant prostate cancer (CRPC), the androgen pathway remains biologically relevant. In preclinical models, androgen therapy for CRPC leads to growth arrest, apoptosis, and tumor shrinkage.Objective
This study sought to determine the toxicity and feasibility of a testosterone therapy in early CRPC.Design, setting, and participants
Prostate cancer patients with progressive disease following androgen ablation, antiandrogen therapy, and withdrawal and no to minimal metastatic disease who were followed at the University of Chicago were randomized to treatment with three doses of transdermal testosterone.Intervention
Patients were treated with transdermal testosterone at 2.5, 5.0, or 7.5 mg/day.Measurements
Toxicity, prostate-specific antigen (PSA), imaging, quality of life (QoL), and strength were monitored. Treatment was discontinued for significant toxicity, clinical progression, or a 3-fold increase in PSA.Results and limitations
Fifteen men with a median age of 73 yr (range: 62–92) and a median PSA of 11.1 ng/ml (range: 5.2–63.6) were treated. Testosterone increased from castrate to median concentrations of 305 ng/dl, 308 ng/dl, and 297 ng/dl for dosages of 2.5 mg/day (n = 4), 5.0 mg/day (n = 5), and 7.5 mg/day (n = 5), respectively. One patient was taken off of the study at 53 wk due to grade 4 cardiac toxicity. There were no other grade 3 or 4 toxicities related to the study medication, and the grade 2 toxicities were minimal. Only one patient experienced symptomatic progression, and three (20%) patients demonstrated a decrease in PSA (largest was 43%). Median time to progression was 9 wk (range: 2–96), with no detectable difference in the three dose cohorts. There was no significant improvement in QoL, and there was a borderline statistically significant improvement in hand-grip strength with treatment. The study was limited by sample size, single arm, and variability of baseline patient characteristics.Conclusions
Testosterone is a feasible and reasonably well-tolerated therapy for men with early CRPC. A larger, randomized trial is under way to further characterize efficacy and impact on QoL measures. 相似文献10.
Inge Geraerts Hendrik Van Poppel Nele Devoogdt Steven Joniau Ben Van Cleynenbreugel An De Groef Marijke Van Kampen 《European urology》2013
Background
The efficacy of preoperative pelvic floor muscle training (PFMT) for urinary incontinence (UI) after open radical prostatectomy (ORP) and robot-assisted laparoscopic radical prostatectomy (RARP) is still unclear.Objective
To determine whether patients with additional preoperative PFMT regain urinary continence earlier than patients with only postoperative PFMT after ORP and RARP.Design, setting, and participants
A randomized controlled trial enrolled 180 men who planned to undergo ORP/RARP.Intervention
The experimental group (E, n = 91) started PFMT 3 wk before surgery and continued after surgery. The control group (C, n = 89) started PFMT after catheter removal.Outcome measurements and statistical analysis
The primary end point was time to continence. Patients measured urine loss daily (24-h pad test) until total continence (three consecutive days of 0 g of urine loss) was achieved. Secondary end points were 1-h pad test, visual analog scale (VAS), International Prostate Symptom Score (IPSS), and quality of life (King's Health Questionnaire [KHQ]). Kaplan-Meier analysis and Cox regression with correction for two strata (age and type of surgery) compared time and continence. The Fisher exact test was applied for the 1-h pad test and VAS; the Mann-Whitney U test was applied for IPSS and KHQ.Results and limitations
Patients with additional preoperative PFMT had no shorter duration of postoperative UI compared with patients with only postoperative PFMT (p = 0.878). Median time to continence was 30 and 31 d, and median amount of first-day incontinence was 108 g and 124 g for groups E and C, respectively. Cox regression did not indicate a significant difference between groups E and C (p = 0.773; hazard ratio: 1.047 [0.768–1.425]). The 1-h pad test, VAS, and IPSS were comparable between both groups. However, “incontinence impact” (KHQ) was in favor of group E at 3 mo and 6 mo after surgery.Conclusions
Three preoperative sessions of PFMT did not improve postoperative duration of incontinence.Trial registration
Netherlands Trial Register No. NTR 1953. 相似文献11.
Dean A. Tripp J. Curtis Nickel Jennifer Wong Michel Pontari Robert Moldwin Robert Mayer Lesley K. Carr Ragi Doggweiler Claire C. Yang Nagendra Mishra Jorgen Nordling 《European urology》2012
Background
Many bladder pain syndrome/interstitial cystitis (BPS/IC) patients report multiple pain locations outside the pelvis. No research has examined pain using a whole-body diagram, pain-associated adjustment factors, or the impact of pain in multiple body areas on patients’ quality of life (QoL).Objective
Compare and contrast pain in BPS/IC patients and controls using a whole-body diagram (visible body areas). Examine the association between patient adjustment factors and greater number of body pain areas (pain phenotypes).Design, setting, and participants
Validated questionnaires were collected from diagnosed, tertiary-care, outpatient, female BPS/IC patients (n = 193) and age-matched controls (n = 115). Scales included a body pain area diagram, demographics/history, pain severity, BPS/IC symptoms, pain, depression, catastrophizing, and QoL.Outcome measurements and statistical analysis
Cross-tabulation and analysis of variance models addressed the patient and control differences.Results and limitations
Patients reported more pain than controls in all reported body areas. Four pain phenotypes were created based on increasing counts of body locations (BPS/IC only, BPS/IC + plus 1–3 additional locations, BPS/IC plus 4–9, BPS/IC ≥10). Patients reported more body pain locations, pain, urinary symptoms, depression, catastrophizing, and diminished QoL than controls. The increased-pain phenotype was associated with poorer psychosocial adjustment and diminished physical QoL, but catastrophizing and low scores for mental QoL remained stable across all patient groups. This study was cross-sectional, relying on correlation-based analyses, thus causality cannot be established.Conclusions
Patients reported numerous systemic pain symptoms outside the areas associated with the bladder/pelvic region, and increased numbers of body pain sites were associated with poorer patient outcomes (ie, pain severity, depression). This study illustrates the significant negative impact of pain on patient adjustment in BPS/IC. These findings suggest that clinicians carefully consider pain location distributions and the potential impact of body pain phenotypes during patient evaluation and treatment planning. 相似文献12.
Tomasz Rechberger Konrad FutymaKatarzyna Jankiewicz Aneta AdamiakPaweł Skorupski 《European urology》2009
Background
Few series comparing the clinical efficacy of retropubic slings versus transobturator slings for the treatment of female stress urinary incontinence (SUI) are available.Objective
To compare clinical efficacy of retropubic tape operations and transobturator suburethral tape operations for the surgical treatment of female SUI.Design, setting, and participants
From January 2003 to December 2005, 611 patients underwent clinical and urodynamic evaluation before surgical treatment for SUI. Patients with advanced urogenital prolapse (pelvic organ prolapse-quantification scale [POP-Q] scale grade >1) were excluded, and 537 patients were included in this study. After 18 mo, 398 women were available for follow-up efficacy evaluation at a tertiary academic center.Intervention
All patients underwent either a retropubic sling procedure or a transobturator sling procedure. Patients were randomly allocated into two study groups at a ratio of 1:1.Measurements
After 18 mo all enrolled patients were clinically checked for clinical efficacy of both procedures.Results and limitations
Demographic and urodynamic parameters of patients were similar in both groups. No bladder injury occurred in the transobturator sling group (IVS-04), whereas 13 intraoperational bladder perforations (6.5%) occurred in the retropubic sling group (IVS-02) (p < 0.001). The tape erosion rate was <2.5% in both groups (p = 0.7). After 18 mo, 398 patients (201 in the IVS-02 group and 197 in the IVS-04 group) were evaluated in terms of clinical efficacy of the procedures. We found out that there was no statistically significant difference in clinical efficacy between these two procedures (χ2 = 1.88, p = 0.39). In the IVS-02 group, 75.1% of patients (n = 151) remained dry (cured), 16.9% of patients (n = 34) reported significant improvement, and 8.0% of patients (n = 16) were considered as failures. In the IVS-04 group, 74.1% of patients (n = 146) remained dry, 14.2% of patients (n = 28) reported significant improvement, and 11.7% (n = 23) were considered as failures.Conclusions
Based on an 18-mo follow-up, the efficacies of both techniques are comparable; however, the retropubic route appears to be more efficient in the intrinsic sphincter deficiency (ISD) group. 相似文献13.
Elizabeth Mann-Salinas Elizabeth Hayes Johnnie Robbins Jean Sabido Laura Feider David Allen Linda Yoder 《Burns : journal of the International Society for Burn Injuries》2014
Aim
To provide a systematic review of the literature regarding development of an evidence-based Precepting Program for nurses transitioning to burn specialty practice.Background
Burned patients are admitted to specialty Burn Centers where highly complex nursing care is provided. Successful orientation and integration into such a specialized work environment is a fundamental component of a nurse's ability to provide safe and holistic patient care.Design
A systematic review of the literature was performed for the period 1995–2011 using electronic databases within PUBMED and Ovid search engines.Data sources
Databases included Medline, CINHAL, ProQuest for Dissertations and Thesis, and Cochran Collaboration using key search terms: preceptor, preceptee, preceptorship, precept*, nurs*, critical care, personality types, competency-based education, and learning styles.Review methods
Nurses graded the level and quality of evidence of the included articles using a modified 7-level rating system and the Johns Hopkins Nursing Quality of Evidence Appraisal during journal-club meetings.Results
A total of 43 articles related to competency (n = 8), knowledge acquisition and personality characteristics (n = 8), learning style (n = 5), preceptor development (n = 7), and Precepting Programs (n = 14).Conclusions
A significant clinical gap existed between the scientific evidence and actual precepting practice of experienced nurses at the Burn Center. Based on this extensive review of the literature, it was determined that a sufficient evidence base existed for development of an evidence-based Precepting Program. 相似文献14.
Liam Bourke Stephen Gilbert Richard Hooper Liz A. Steed Miland Joshi Jim W.F. Catto John M. Saxton Derek J. Rosario 《European urology》2014
Background
Prostate cancer is a key driver of cancer-related global disability-adjusted life-years. Androgen-deprivation therapy (ADT) for advanced disease is linked to fatigue, reduced physical function, and quality of life (QoL).Objective
To evaluate the effect of a lifestyle intervention on disease-specific QoL, diastolic blood pressure, and cancer-related fatigue in sedentary men receiving long-term ADT for advanced prostate cancer.Design, setting, and participants
A total of 100 hundred sedentary men with locally advanced or metastatic prostate cancer on long-term ADT were randomised to an intervention or usual care group.Intervention
A 12-wk lifestyle intervention consisting of aerobic and resistance exercise with parallel dietary advice.Outcome measurements and statistical analysis
Disease-specific QoL was measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Functional Assessment of Cancer Therapy-Fatigue (FACT-F) questionnaires at 12 wk postintervention and at 6 mo following withdrawal of support. Analysis of covariance and mixed regression were conducted.Results and limitations
Clinically relevant improvements in FACT-P were seen at 12 wk in the intervention group compared with controls (mean difference: 8.9 points; 95% confidence interval [CI], 3.7–14.2; adjusted p = 0.001). No difference was apparent at 6 mo (mean difference: 3.3 points; 95% CI, −2.6 to 9.3; adjusted p = 0.27). No difference in diastolic blood pressure was seen at either follow-up (all p > 0.05). Clinically relevant improvements in FACT-F were seen at 12 wk (mean difference: 5.3 points; 95% CI, 2.7–7.9; adjusted p < 0.001) and maintained following withdrawal of supervision (mean difference: 3.9 points; 95% CI, 1.1–6.8; adjusted p = 0.007). Improvements in exercise tolerance and behaviour were maintained at 6 mo (adjusted p < 0.001 and 0.038).Conclusions
A lifestyle intervention resulted in a clinically meaningful improvement in disease-specific QoL that was not maintained postintervention. No effect on blood pressure occurred. Durability of response was seen in fatigue and exercise behaviour. Further evaluation of support structures is essential.Trial registration
ISRCTN88605738. 相似文献15.
Laurence Klotz Kurt Miller E. David Crawford Neal Shore Bertrand Tombal Cathrina Karup Anders Malmberg Bo-Eric Persson 《European urology》2014
Background
Studies comparing the gonadotropin-releasing hormone antagonist, degarelix, with luteinising hormone-releasing hormone (LHRH) agonists indicate differences in outcomes.Objective
To assess differences in efficacy and safety outcomes in a pooled analysis of trials comparing degarelix with LHRH agonists.Design, setting, and participants
Data were pooled from five prospective, phase 3 or 3b randomised trials (n = 1925) of degarelix and leuprolide or goserelin in men requiring androgen deprivation therapy for the treatment of prostate cancer. Patients received either 3 mo (n = 467) or 12 mo (n = 1458) of treatment.Intervention
Men were randomised to receive degarelix (n = 1266), leuprolide (n = 201), or goserelin (n = 458).Outcome measurements and statistical analysis
Unadjusted Kaplan-Meier analyses were supported by the Cox proportional hazards model, adjusted for disease-related baseline factors, to estimate hazard ratios (HRs) of efficacy and safety outcomes. The Fisher exact test compared crude incidences of adverse events.Results and limitations
Prostate-specific antigen (PSA) progression-free survival (PFS) was improved in the degarelix group (HR: 0.71; p = 0.017). For patients with baseline PSA levels >20 ng/ml, the HR for PSA PFS was 0.74 (p = 0.052). Overall survival (OS) was higher in the degarelix group (HR: 0.47; p = 0.023). OS was particularly improved with degarelix in patients with baseline testosterone levels >2 ng/ml (HR: 0.36; p = 0.006). In terms of disease-related adverse events, there were, overall, fewer joint-related signs and symptoms, musculoskeletal events, and urinary tract events in the degarelix group.Conclusions
These data indicate clinical benefits with degarelix, including a significant improvement in PSA PFS and OS, as well as reduced incidence of joint, musculoskeletal, and urinary tract adverse events, compared with LHRH agonists. 相似文献16.
Background
β-Adrenoceptor agonists are effective in animal models of bladder dysfunction, and the human bladder primarily expresses the β3 receptor subtype.Objective
To evaluate the efficacy and tolerability of the highly selective and potent β3-adrenoceptor agonist solabegron in a clinical proof-of-concept study in incontinent women with overactive bladder (OAB).Design, setting, and participants
This was a randomized, double-blind trial in adult women with OAB (one or more 24-h incontinence episodes and eight or more average 24-h micturitions).Interventions
Solabegron 50 mg (n = 88), solabegron 125 mg (n = 85), or placebo (n = 85)—all twice daily—were administered.Outcome measurements and statistical analysis
The primary efficacy end point was percentage change from baseline to week 8 in the number of incontinence episodes over 24 h. Secondary end points included actual change and percentage change from baseline to week 4 and week 8 in micturitions per 24 h, urgency episodes per 24 h, and volume voided per micturition. Adverse events (AEs) were assessed, as well.Results and limitations
Solabegron 125 mg produced a statistically significant difference in percent change from baseline to week 8 in incontinence episodes over 24 h when compared with placebo (p = 0.025). Solabegron 125 mg treatment also showed statistically significant reductions from baseline to weeks 4 and 8 in micturitions over 24 h and a statistically significant increase from baseline to week 8 in urine volume voided. Solabegron was well tolerated, with a similar incidence of AEs in each treatment group. There were no significant treatment differences for mean changes from baseline to week 8 in systolic blood pressure (BP), diastolic BP, mean arterial pressure (MAP), or heart rate during the 24-h ambulatory measurement.Conclusions
Solabegron significantly reduced the symptoms of OAB in women with moderate to severe OAB. Solabegron was safe, well tolerated, and did not demonstrate significant differences in AEs as compared to placebo. β3-Adrenoceptor agonists may represent a new therapeutic approach for treating OAB symptoms. 相似文献17.
Michael Marberger Emmanuel Chartier-Kastler Blair Egerdie Kyu-Sung Lee Joachim Grosse Denise Bugarin Jihao Zhou Anand Patel Cornelia Haag-Molkenteller 《European urology》2013
Background
Botulinum toxin treatment has been investigated as a minimally invasive alternative to oral medications in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (LUTS/BPH).Objective
To explore the efficacy of onabotulinumtoxinA 100 U, 200 U, and 300 U versus placebo in men with LUTS/BPH in a phase 2 dose-ranging study.Design, setting, and participants
A multicenter double-blind randomized, placebo-controlled 72-wk study enrolled men ≥50 yr of age with LUTS/BPH, International Prostate Symptom Score (IPSS) ≥12, total prostate volume (TPV) 30–100 ml, and maximum flow rate (Qmax) 5–15 ml/s.Intervention
Single transperineal (n = 63) or transrectal (n = 311) administration of placebo (n = 94) or onabotulinumtoxinA 100 U (n = 95), 200 U (n = 94), or 300 U (n = 97) into the prostate transition zone.Outcome measurements and statistical analysis
The primary efficacy end point was a change from baseline in IPSS at week 12. Secondary end points were Qmax, TPV, and transition zone volume (TZV). Analysis of covariance and the Cochran-Mantel-Haenszel method assessed the efficacy and proportion of IPSS responders. Adverse events (AEs) were assessed.Results and limitations
Significant improvements from baseline in IPSS, Qmax, TPV, and TZV were observed for all groups, including placebo, at week 12 (p < 0.001), with no significant differences between onabotulinumtoxinA and placebo. However, in an exploratory post hoc analysis, a significant reduction in IPSS versus placebo was observed with onabotulinumtoxinA 200 U in prior α-blocker users (n = 180) at week 12. AEs were comparable across all groups.Conclusions
Reductions in LUTS/BPH symptoms were seen in all groups, including placebo, with no significant between-group differences owing to a large placebo effect from the injectable therapy. The findings from the post hoc analysis in men previously treated with α-blockers will be further explored in an appropriately designed study.Trial registration
http://www.Clinical Trials.gov; NCT00284518. 相似文献18.
Cruz F Herschorn S Aliotta P Brin M Thompson C Lam W Daniell G Heesakkers J Haag-Molkenteller C 《European urology》2011,60(4):742-750
Background
Neurogenic detrusor overactivity (NDO) frequently results in urinary incontinence (UI) which impairs quality of life (QOL) and puts the upper urinary tract at risk.Objective
To assess the effects of onabotulinumtoxinA (BOTOX®, Allergan, Inc.) on UI, urodynamic variables, and QOL in incontinent patients with NDO.Design, setting, and participants
This multicentre, randomised, double-blind, placebo-controlled study enrolled patients with multiple sclerosis (MS; n = 154) or spinal cord injury (SCI; n = 121) with UI due to NDO (≥14 UI episodes per week).Intervention
Patients received 30 intradetrusor injections of onabotulinumtoxinA 200 U (n = 92), 300 U (n = 91), or placebo (n = 92), avoiding the trigone.Measurements
Primary end point was change from baseline in UI episodes per week (week 6). Secondary end points included urodynamics (maximum cystometric capacity [MCC], maximum detrusor pressure during first involuntary detrusor contraction [PdetmaxIDC]), and Incontinence Quality of Life (I-QOL) total score. Adverse events (AEs) were assessed.Results and limitations
At baseline, mean UI episodes per week (33.5) were similar across groups. At week 6, onabotulinumtoxinA 200 U and 300 U significantly reduced UI episodes per week (−21.8 and −19.4, respectively) compared with placebo (−13.2; p < 0.01); onabotulinumtoxinA benefit was observed by the first posttreatment study visit at week 2. Improvements in MCC, PdetmaxIDC, and I-QOL at week 6 were significantly greater with both onabotulinumtoxinA doses than with placebo (p < 0.001). Benefits were observed in both the MS and SCI populations. The median time to patient request for retreatment was the same for both onabotulinumtoxinA doses (42.1 wk) and greater than placebo (13.1 wk; p < 0.001). Most frequent AEs were localised urologic events (urinary tract infections and urinary retention, which were dose related in patients not using clean intermittent catheterisation [CIC] at baseline). Significant increases in postvoid residual were observed in patients not using CIC prior to treatment, and 12%, 30%, and 42% of patients in the placebo, 200-U, and 300-U groups, respectively, initiated CIC posttreatment.Conclusions
OnabotulinumtoxinA significantly reduced UI and improved urodynamics and QOL in MS and SCI patients with NDO. Both doses were well tolerated with no clinically relevant differences in efficacy or duration of effect between the two doses (http://www.clinicaltrials.gov; NCT00461292). 相似文献19.
Rana R. McKay Xun Lin Julia J. Perkins Daniel Y.C. Heng Ronit Simantov Toni K. Choueiri 《European urology》2014
Background
Bone metastases (BMs) are frequently present in patients with metastatic renal cell carcinoma (mRCC) and cause significant morbidity.Objective
The purpose of this analysis was to assess the impact of BMs and bisphosphonate therapy (BT) on outcomes in mRCC.Design, setting, and participants
We conducted a pooled analysis of patients with mRCC treated from 2003 to 2011 in phase 2 and 3 trials.Outcome measurements and statistical analysis
Statistical analyses were performed using Cox regression and the Kaplan-Meier method.Results and limitations
We identified 2749 patients treated with sunitinib (n = 1059), sorafenib (n = 355), axitinib (n = 359), temsirolimus (n = 208), temsirolimus plus interferon-α (IFN-α) (n = 208), or IFN-α (n = 560), with 28% (n = 781) having BMs. A total of 285 patients (10.4%) received BT. The presence of BMs in patients was associated with shorter overall survival (OS) when compared with patients without BMs (13.2 vs 20.2 mo, respectively; p < 0.0001) and shorter progression-free survival (PFS) (5.1 vs 6.7 mo, respectively; p < 0.0008). When stratified by risk groups, the presence of BMs was associated with shorter OS in all risk groups. The use of BT in patients with BMs was not associated with improved OS compared with patients who did not receive BT (13.3 vs 13.1 mo, respectively; p = 0.3801) or improved PFS (5.1 vs 4.9 mo, respectively; p = 0.1785). Bisphosphonate users with BMs did not have a decreased rate of skeletal-related events (SREs) compared with nonusers (8.6% vs 5.8%, respectively; p = 0.191). In addition, BT was associated with increased rates of hypocalcemia, renal insufficiency, and osteonecrosis of the jaw (p < 0.0001). Data were analyzed retrospectively.Conclusions
We confirm that the presence of BMs is associated with shorter survival in mRCC. BT did not affect survival or SRE prevention and was associated with increased toxicity.Patient summary
In this analysis, we demonstrate that bone metastases are associated with shorter survival in patients with metastatic renal cell carcinoma. In addition, we call into question the utility of bisphosphonate therapy in this population. 相似文献20.
Jorge A. Ramirez Andrew G. McIntosh Robert Strehlow Valerie A. Lawrence Dipen J. Parekh Robert S. Svatek 《European urology》2013