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1.
Gacci M Corona G Salvi M Vignozzi L McVary KT Kaplan SA Roehrborn CG Serni S Mirone V Carini M Maggi M 《European urology》2012,61(5):994-1003
Context
Several randomized controlled trials (RCTs) on phosphodiesterase type 5 inhibitors (PDE5-Is) have showed significant improvements in both lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) in men affected by one or both conditions, without a significant increase in adverse events. However, the results are inconsistent.Objective
Perform a systematic review and meta-analysis of available prospective and cross-sectional studies on the use of PDE5-Is alone or in combination with α1-adrenergic blockers in patients with LUTS/benign prostatic hyperplasia (BPH).Evidence acquisition
A systematic search was performed using the Medline, Embase, and Cochrane Library databases through September 2011 including the combination of the following terms: LUTS, BPH, PDE5-Is, sildenafil, tadalafil, vardenafil, udenafil, α-blockers, and α1-adrenergic blocker. The meta-analysis was conducted according to the guidelines for observational studies in epidemiology.Evidence synthesis
Of 107 retrieved articles, 12 were included in the present meta-analysis: 7 on PDE5-Is versus placebo, with 3214 men, and 5 on the combination of PDE5-Is with α1-adrenergic blockers versus α1-adrenergic blockers alone, with 216 men. Median follow-up of all RCTs was 12 wk.Combining the results of those trials, the use of PDE5-Is alone was associated with a significant improvement of the International Index of Erectile Function (IIEF) score (+5.5; p < 0.0001) and International Prostate Symptom Score (IPSS) (−2.8; p < 0.0001) but not the maximum flow rate (Qmax) (−0.00; p = not significant) at the end of the study as compared with placebo. The association of PDE5-Is and α1-adrenergic blockers improved the IIEF score (+3.6; p < 0.0001), IPSS score (−1.8; p = 0.05), and Qmax (+1.5; p < 0.0001) at the end of the study as compared with α-blockers alone.Conclusions
The meta-analysis of the available cross-sectional data suggests that PDE5-Is can significantly improve LUTS and erectile function in men with BPH. PDE5-Is seem to be a promising treatment option for patients with LUTS secondary to BPH with or without ED. 相似文献2.
Hartmut Porst Kevin T. McVary Francesco Montorsi Peter Sutherland Albert Elion-Mboussa Anne M. Wolka Lars Viktrup 《European urology》2009,56(4):727-736
Background
Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH; BPH-LUTS) may be associated with erectile dysfunction (ED).Objective
To evaluate the effects of once-daily tadalafil on erectile function in men with ED and BPH-LUTS.Design, setting, and participants
Post hoc analysis of a phase 2–3, multinational, randomized, double-blind, placebo-controlled, parallel-group study of men with ED and moderate-to-severe LUTS secondary to BPH who reported being sexually active. In contrast to typical ED trials, no sexual activity threshold was required to participate.Interventions
Screening and 4-wk washout period for patients taking BPH and/or ED treatments; 4-wk placebo run-in period; then once-daily placebo or tadalafil 2.5, 5, 10, or 20 mg for 12 wk.Measurements
International Index of Erectile Function–Erectile Function (IIEF-EF) domain score, International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), and postvoid residual volume (PVR). Analyses were performed in men who reported being sexually active with a female partner and who expected to remain so throughout the study. IIEF-EF data are presented for the BPH/ED population overall and for subgroups stratified by baseline age group, body mass index, BPH-LUTS severity, prostate-specific antigen, prior α-blocker use, and prior ED therapy.Results and limitations
Overall, 581 men were included (placebo, n = 115; tadalafil 2.5 mg, n = 113; tadalafil 5 mg, n = 117; tadalafil 10 mg, n = 120; tadalafil 20 mg, n = 116). IIEF-EF domain score improvements from baseline to end point with tadalafil were 5.4 (2.5 mg), 6.8 (5 mg), 7.9 (10 mg), and 8.2 (20 mg) versus 2.0 with placebo (least-squares means; all p values <0.001). IIEF-EF domain score improvements were observed with tadalafil for all subgroup analyses, with no significant differences between subgroup or subgroup-by-treatment interaction terms. IPSS improvements from baseline to end point were significantly greater for all tadalafil doses versus placebo (all p values <0.05). Changes in Qmax and PVR were small and not clinically meaningful.Conclusions
These data support the use of once-daily tadalafil in men with ED and BPH-LUTS.Trial registration
http://www.clinicaltrials.gov: NCT00384930. 相似文献3.
Florian M.E. Wagenlehner Henning Schneider Martin Ludwig Jrg Schnitker Elmar Brhler Wolfgang Weidner 《European urology》2009,56(3):544-551
Background
National Institutes of Health (NIH) category III prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a prevalent condition for which no standardised treatment exists.Objectives
To assess the safety and efficacy of a standardised pollen extract in men with inflammatory CP/CPPS.Design, setting, and participants
We conducted a multicentre, prospective, randomised, double-blind, placebo-controlled phase 3 study comparing the pollen extract (Cernilton) to placebo in men with CP/CPPS (NIH IIIA) attending urologic centres.Intervention
Participants were randomised to receive oral capsules of the pollen extract (two capsules q8 h) or placebo for 12 wk.Measurements
The primary endpoint of the study was symptomatic improvement in the pain domain of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Participants were evaluated using the NIH-CPSI individual domains and total score, the number of leukocytes in post–prostatic massage urine (VB3), the International Prostate Symptom Score (IPSS), and the sexuality domain of a life satisfaction questionnaire at baseline and after 6 and 12 wk.Results and limitations
In the intention-to-treat analysis, 139 men were randomly allocated to the pollen extract (n = 70) or placebo (n = 69). The individual domains pain (p = 0.0086) and quality of life (QoL; p = 0.0250) as well as the total NIH-CPSI score (p = 0.0126) were significantly improved after 12 wk of treatment with pollen extract compared to placebo. Response, defined as a decrease of the NIH-CPSI total score by at least 25% or at least 6 points, was seen in the pollen extract versus placebo group in 70.6% and 50.0% (p = 0.0141), respectively. Adverse events were minor in all patients studied.Conclusions
Compared to placebo, the pollen extract significantly improved total symptoms, pain, and QoL in patients with inflammatory CP/CPPS without severe side-effects. 相似文献4.
Thomas Hermanns Peter Sauermann Kaspar Rufibach Thomas Frauenfelder Tullio Sulser Rto T. Strebel 《European urology》2009,56(3):407-412
Background
Numerous randomised trials have confirmed the efficacy of medical expulsive therapy with tamsulosin in patients with distal ureteral stones; however, to date, no randomised, double-blind, placebo-controlled trials have been performed.Objective
The objective of this trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a randomised, double-blind, placebo-controlled setting.Design, setting, and participants
Patients presenting with single distal ureteral stones ≤7 mm were included in this trial.Intervention
Patients were randomised in a double-blind fashion to receive either tamsulosin or placebo for 21 d. The medication was discontinued after either stone expulsion or intervention. Abdominal computed tomography was performed to assess the initial and final stone status.Measurements and limitations
The primary end point was the stone expulsion rate. Secondary end points were time to stone passage, the amount of analgesic required, the maximum daily pain score, safety of the therapy, and the intervention rate.Results
Ten of 100 randomised patients were excluded from the analysis. No statistically significant differences in patient characteristics and stone size (median: 4.1 mm [tamsulosin arm] vs 3.8 mm [placebo arm], p = 0.3) were found between the two treatment arms. The stone expulsion rate was not significantly different between the tamsulosin arm (86.7%) and the placebo arm (88.9%; p = 1.0). Median time to stone passage was 7 d in the tamsulosin arm and 10 d in the placebo arm (log-rank test, p = 0.36). Patients in the tamsulosin arm required significantly fewer analgesics than patients in the placebo arm (median: 3 vs 7, p = 0.011). A caveat is that the exact time of stone passage was missing for 29 patients.Conclusions
Tamsulosin treatment does not improve the stone expulsion rate in patients with distal ureteral stones ≤7 mm. Nevertheless, patients may benefit from a supportive analgesic effect.Clinicaltrials.gov
NCT00831701. 相似文献5.
Cornu JN Merlet B Ciofu C Mouly S Peyrat L Sèbe P Yiou R Vallancien G Debrix I Laribi K Cussenot O Haab F 《European urology》2011,59(1):148-154
Background
Duloxetine is effective in the management of stress urinary incontinence (SUI) in women but has been poorly evaluated in the treatment of SUI following radical prostatectomy (RP).Objective
To establish the superiority of duloxetine over placebo in SUI after RP.Design, setting, and participants
We conducted a prospective, randomised, placebo-controlled, double-blind, monocentric superiority trial. After a placebo run-in period of 2 wk, patients with SUI after RP were randomised to receive either 80 mg of duloxetine daily or matching placebo for 3 mo.Measurements
The primary outcome measure was the relative variation in incontinence episodes frequency (IEF) at the end of study compared to baseline. Secondary outcomes included quality of life (QoL) measures (Incontinence Impact Questionnaire Short Form [IIQ-SF], Urogenital Distress Inventory Short Form [UDI-SF], Incontinence Quality of Life [I-QoL]), symptom scores (Urinary Symptom Profile [USP] questionnaire, International Consultation on Incontinence/World Health Organisation Short Form questionnaire [ICIQ-SF], the Beck Depression Inventory [BDI-II] questionnaire), 1-h pad test, and assessment of adverse events.Results and limitations
Thirty-one patients were randomised to either the treatment (n = 16) or control group (n = 15). Reduction in IEF was significant with duloxetine compared to placebo (mean ± standard deviation [SD] variation: −52.2% ± 38.6 [range: −100 to +46] vs +19.0% ± 43.5 [range: −53 to +104]; mean difference: 71.2%; 95% confidence interval [CI] for the difference: 41.0–101.4; p < 0.0001). IIQ-SF total score, UDI-SF total score, SUI subscore of the USP questionnaire, and question 3 of the ICIQ-SF questionnaire showed improvement in the duloxetine group (p = 0.006, p = 0.02, p = 0.0004, and p = 0.003, respectively). Both treatments were well tolerated throughout the study period.Conclusions
Duloxetine is effective in the treatment of incontinence symptoms and improves QoL in patients with SUI after RP. 相似文献6.
Huang AC Kowalczyk KJ Hevelone ND Lipsitz SR Yu HY Plaster BA Amarasekara CA Ulmer WD Lei Y Williams SB Hu JC 《European urology》2011,59(4):595-603
Background
Large prostate size, median lobes, and prior benign prostatic hyperplasia (BPH) surgery may pose technical challenges during robot-assisted laparoscopic prostatectomy (RALP).Objective
To describe technical modifications to overcome BPH sequelae and associated outcomes.Design, settings, and participants
A retrospective study of prospective data on 951 RALP procedures performed from September 2005 to November 2010 was conducted. Outcomes were analyzed by prostate weight, prior BPH surgical intervention (n = 59), and median lobes >1 cm (n = 42).Surgical procedure
RALP.Measurements
Estimated blood loss (EBL), blood transfusions, operative time, positive surgical margin (PSM), and urinary and sexual function were measured.Results and limitations
In unadjusted analysis, men with larger prostates and median lobes experienced higher EBL (213.5 vs 176.5 ml; p < 0.001 and 236.4 vs 193.3 ml; p = 0.002), and larger prostates were associated with more transfusions (4 vs 1; p = 0.037). Operative times were longer for men with larger prostates (164.2 vs 149.1 min; p = 0.002), median lobes (185.8 vs 155.0 min; p = 0.004), and prior BPH surgical interventions (170.2 vs 155.4 min; p = 0.004). Men with prior BPH interventions experienced more prostate base PSM (5.1% vs 1.2%; p = 0.018) but similar overall PSM. In adjusted analyses, the presence of median lobes increased both EBL (p = 0.006) and operative times (p < 0.001), while prior BPH interventions also prolonged operative times (p = 0.014). However, prostate size did not affect EBL, PSM, or recovery of urinary or sexual function.Conclusions
Although BPH characteristics prolonged RALP procedure times and increased EBL, prostate size did not affect PSM or urinary and sexual function. 相似文献7.
Sunay D Sunay M Aydoğmuş Y Bağbancı S Arslan H Karabulut A Emir L 《European urology》2011,59(5):765-771
Background
Acupuncture therapy has been used by many researchers in both male and female sexual dysfunction studies.Objective
To determine whether acupuncture is effective as a premature ejaculation (PE) treatment compared with paroxetine and placebo.Design, setting, and participants
The study was conducted with methodologic rigor based on Consolidated Standards of Reporting Trials (CONSORT) criteria. Ninety patients referred to the urology clinic at a tertiary training and research hospital with PE were included in this randomized controlled trial and randomly assigned into paroxetine, acupuncture, and placebo groups. Heterosexual, sexually active men aged between 28 and 50 yr were included. Men with other sexual disorders, including erectile dysfunction; with chronic psychiatric or systemic diseases; with alcohol or substance abuse; or who used any medications were excluded.Intervention
The medicated group received paroxetine 20 mg/d; the acupuncture or sham-acupuncture (placebo) groups were treated twice a week for 4 wk.Measurements
Intravaginal ejaculation latency times (IELTs) and the Premature Ejaculation Diagnostic Tool (PEDT) were used to assess PE. IELTs were calculated by using a partner-held stopwatch. Data were analyzed statistically.Results and limitations
Median PEDT scores of paroxetine, acupuncture, and placebo groups were 17.0, 16.0, and 15.5 before treatment, and 10.5, 11.0, and 16.0 after treatment, respectively (p = 0.001, p = 0.001, and p = 0.314, respectively). Subscores after treatment were significantly lower than subscores before treatment in the paroxetine and acupuncture groups but remained the same in the placebo group. Significant differences were found between mean-rank IELTs of the paroxetine and placebo groups (p = 0.001) and the acupuncture and placebo groups (p = 0.001) after treatment. Increases of IELTs with paroxetine, acupuncture, and placebo acupuncture were 82.7, 65.7, and 33.1 s, respectively. Extent of ejaculation delay induced by paroxetine was significantly higher than that of acupuncture (p = 0.001). The most important limitation of the study was the lack of follow-up.Conclusions
Although less effective than daily paroxetine, acupuncture had a significant stronger ejaculation-delaying effect than placebo. 相似文献8.
Background
Little is known about dietary correlates of lower urinary tract symptoms (LUTS).Objective
To examine associations between dietary intakes of total energy, carbohydrates, protein, fats, cholesterol, and sodium and LUTS in men.Design, setting, and participants
Cross-sectional study of 1545 men aged 30–79 yr in the Boston Area Community Health survey (2002–2005), a random population-based sample. Dietary data were assessed by validated self-administered food frequency questionnaire. LUTS and covariate data were collected during in-person interviews. Primary analyses used multivariate logistic regression.Measurements
Outcomes were moderate to severe LUTS, storage symptoms, and voiding symptoms as measured by the American Urological Association Symptom Index.Results and limitations
Greater total energy intake was associated with higher LUTS symptom score (ptrend < 0.01) and increased likelihood of storage symptoms. No associations were observed with total, saturated, or monounsaturated fat intake or carbohydrates. Men who consumed more protein were less likely to report LUTS, particularly voiding symptoms (quintile 5 vs quintile 1 OR = 0.35; 95% CI, 0.17–0.74; p = 0.006). Sodium intake had positive linear associations with LUTS (ptrend = 0.01) and storage symptom score (ptrend = 0.004); this finding should be confirmed by studies using biomarkers of sodium exposure. Storage symptoms increased slightly with greater polyunsaturated fat intake (ptrend = 0.006). Data on specific polyunsaturated fats were unavailable.Conclusions
This community-based study of men found that total energy and sodium intake were positively associated with LUTS, whereas greater protein intake was inversely associated with LUTS. 相似文献9.
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10.
Philip Van Kerrebroeck François Haab Javier C. Angulo Viktor Vik Ferenc Katona Alberto Garcia-Hernandez Monique Klaver Klaudia Traudtner Matthias Oelke 《European urology》2013
Background
Storage symptoms are often undertreated in men with lower urinary tract symptoms (LUTS).Objective
To evaluate the combination of an antimuscarinic (solifenacin) with an α-blocker (tamsulosin) versus tamsulosin alone in the treatment of men with LUTS.Design, setting, and participants
A double-blind, 12-wk, phase 2 study in 937 men with LUTS (≥3 mo, total International Prostate Symptom Score [IPSS] ≥13, and maximum urinary flow rate 4.0–15.0 ml/s).Intervention
Eight treatment groups: tamsulosin oral controlled absorption system (OCAS) 0.4 mg; solifenacin 3, 6, or 9 mg; solifenacin 3, 6 or 9 mg plus tamsulosin OCAS 0.4 mg; or placebo.Outcome measurements and statistical analysis
The primary efficacy end point was change from baseline in total IPSS. Secondary end points included micturition diary and quality-of-life (QoL) parameters. Post hoc subgroup analyses were performed by severity of baseline storage symptoms, with statistical comparisons presented only for tamsulosin OCAS alone versus combination therapy, due to the small sample size of the solifenacin monotherapy and placebo subgroups.Results and limitations
Combination therapy was associated with significant improvements in micturition frequency and voided volume versus tamsulosin OCAS alone in the total study population; improvements in total IPSS were not significant. Statistically significant improvements in urgency episodes, micturition frequency, total urgency score, voided volume, IPSS storage subscore, IPSS-QoL index, and Patient Perception of Bladder Condition were observed in a subpopulation of men with two or more urgency episodes per 24 h (Patient Perception of Intensity of Urgency Scale grade 3 or 4) and eight or more micturitions per 24 h at baseline (storage symptoms subgroup) with combination therapy versus tamsulosin OCAS alone (p ≤ 0.05 for the dose–response slope, all variables). Combination therapy was well tolerated, and adverse events were consistent with the safety profiles of both compounds.Conclusions
Solifenacin plus tamsulosin OCAS did not significantly improve IPSS in the total study population but offered significant efficacy and QoL benefits over tamsulosin OCAS monotherapy in men with both voiding and storage symptoms at baseline. Combination therapy was well tolerated.ClinicalTrials.gov identifier
NCT00510406 相似文献11.
Context
Laparoendoscopic single-site (LESS) surgery has increasingly been used to perform radical, partial, simple, or donor nephrectomy to reduce the morbidity and scarring associated with surgical intervention. Studies comparing LESS nephrectomy (LESS-N) and conventional laparoscopic nephrectomy (CL-N) have reported conflicting results.Objective
To assess the current evidence regarding the efficiency, safety, and potential advantages of LESS-N compared with CL-N.Evidence acquisition
We comprehensively searched PubMed, Embase, and the Cochrane Library and performed a systematic review and cumulative meta-analysis of all randomized controlled trials (RCTs) and retrospective comparative studies assessing the two techniques.Evidence synthesis
Two RCTs and 25 retrospective studies including a total of 1094 cases were identified. Although LESS-N was associated with a longer operative time (weighted mean difference [WMD]: 9.87 min; 95% confidence interval [CI], 3.37–16.38; p = 0.003) and a higher conversion rate (6% compared with 0.3%; odds ratio: 4.83; 95% CI, 1.87–12.45; p = 0.001), patients in this group might benefit from less postoperative pain (WMD: −0.48; 95% CI, −0.95 to −0.02; p = 0.04), lower analgesic requirement (WMD: −4.78 mg; 95% CI, −8.59 to −0.97; p = 0.01), shorter hospital stay (WMD: −0.32 d; 95% CI, −0.55 to −0.09; p = 0.007), shorter recovery time (WMD: −5.08 d; 95% CI, −8.49 to −1.68; p = 0.003), and better cosmetic outcome (WMD: 1.07; 95% CI, 0.67–1.48; p < 0.00001). Perioperative complications, estimated blood loss, warm ischemia time, and postoperative serum creatinine levels of graft recipients did not differ significantly between techniques.Conclusions
LESS-N offers a safe and efficient alternative to CL-N with less pain, shorter recovery time, and better cosmetic outcome. Given the inherent limitations of the included studies, future well-designed RCTs are awaited to confirm and update the findings of this analysis. 相似文献12.
Damiano R Quarto G Bava I Ucciero G De Domenico R Palumbo MI Autorino R 《European urology》2011,59(4):645-651
Background
Urinary tract infection (UTI) is a prevalent condition in women during their lifetime with a high rate of recurrence within 3–6 mo.Objectives
Our aim was to investigate the efficacy and tolerability of the intravesical administration of combined hyaluronic acid (HA) and chondroitin sulphate (CS) in female patients with a history of recurrent UTI.Design, setting, and participants
We conducted a prospective, randomised, double-blind, placebo-controlled study comparing the intravesical instillation of HA-CS with placebo in women with recurrent UTI.Intervention
Participants were randomised to receive 50 ml of sterile sodium HA 1.6% and CS 2.0% solution (IALURIL®) weekly for 4 wk and then monthly for 5 mo.Measurements
The primary end point of the study was defined as the mean number of UTI per patient per year. Participants were evaluated addressing UTI status/urinary symptoms and with a general health-related quality-of-life (QoL) questionnaire at baseline and after 3, 6, 9, and 12 mo.Results and limitations
In the intention-to-treat analysis, 57 women were randomly allocated to HA-CS (n = 28) or placebo (n = 29). The UTI rate per patient per year at the end of the study (12 mo) (mean ± SD: −86.6% ± 47.6 vs −9.6% ± 24.6; mean difference: 77%; 95% confidence interval, 72.3–80.8; p = 0.0002) and the mean time to UTI recurrence (52.7 ± 33.4 vs 185.2 ± 78.7 d; p < 0.001) were significantly reduced after treatment with HA-CS compared with placebo. Overall urinary symptoms and QoL measured by questionnaires significantly improved compared with placebo (Pelvic Pain and Urgency/Frequency questionnaire symptom score: 14.53 ± 4.32 vs 9.88 ± 6.77; p = 0.004; SF-36 QoL score: 78.6 ± 6.44 vs 53.1 ± 4.72; p < 0.001). No serious adverse event was reported.Conclusions
Compared with placebo, HA-CS intravesical instillations significantly reduced UTI rate without severe side effects while improving symptoms and QoL over a 12-mo period in patients with recurrent UTI.Trial registration
ISRCTN 76354426. 相似文献13.
Marcos P. Freire Aaron C. Weinberg Yin Lei Jane R. Soukup Stuart R. Lipsitz Sandip M. Prasad Fernando Korkes Tiffany Lin Jim C. Hu 《European urology》2009,56(6):972-980
Background
Robotic-assisted laparoscopic radical prostatectomy (RALP) has been rapidly adopted despite a daunting learning curve with bladder neck dissection as a challenging step for newcomers.Objective
To describe an anatomic, reproducible technique of bladder neck preservation (BNP) and associated perioperative and long-term outcomes.Design, settings, and participants
From September 2005 to May 2009, data from 619 consecutive RALP were prospectively collected and compared on the basis of bladder neck dissection technique with 348 BNP and 271 standard technique (ST).Surgical procedure
RALP with BNP.Measurements
Tumor characteristics, perioperative complications, and post-operative urinary control were evaluated at 4, 12 and 24 months using (1) the Expanded Prostate Cancer Index (EPIC) urinary function scale scored from 0–100; and (2) continence defined as zero pads per day.Results and limitations
Mean age for BNP versus ST was 57.1 ± 6.6 yr versus 58.9 ± 6.7 yr (p = 0.033), while complication rates did not vary significantly by technique. Estimated blood loss was 183.7 ± 95.8 ml versus 224.6 ± 108 ml (p = 0.938) in men who underwent BNP versus ST. The overall positive margin rate was 12.8%, which did not differ at the prostate base for BNP versus ST (1.4% vs. 2.2%, p = 0.547). Mean urinary function scores for BNP versus ST at 4, 12, and 24 mo were 64.6 versus 57.2 (p = 0.037), 80.6 versus 79.0 (p = 0.495), and 94.1 versus 86.8 (p < 0.001). Similarly, BNP versus ST continence rates at 4, 12, and 24 mo were 65.6% versus 26.5% (p < 0.001), 86.4% versus 81.4% (p = 0.303), and 100% versus 96.1% (p = 0.308).Conclusions
BNP versus ST is associated with quicker recovery of urinary function and similar cancer control. 相似文献14.
Francesco Montorsi Gerald Brock Jens-Uwe Stolzenburg John Mulhall Ignacio Moncada Hitendra R.H. Patel Daniel Chevallier Kazimierz Krajka Carsten Henneges Ruth Dickson Hartwig Büttner 《European urology》2014
Background
The potential rehabilitative and protective effect of phosphodiesterase type 5 inhibitors (PDE5-Is) on penile function after nerve-sparing radical prostatectomy (NSRP) remains unclear.Objective
The primary objective was to compare the efficacy of tadalafil 5 mg once daily and tadalafil 20 mg on demand versus placebo taken over 9 mo in improving unassisted erectile function (EF) following NSRP, as measured by the proportion of patients achieving an International Index of Erectile Function-Erectile Function domain (IIEF-EF) score ≥22 after 6-wk drug-free washout (DFW). Secondary measures included IIEF-EF, Sexual Encounter Profile question 3 (SEP-3), and penile length.Design, setting, and participants
Randomised, double-blind, double-dummy, placebo-controlled trial in men ≤68 yr of age with adenocarcinoma of the prostate (Gleason ≤7) and normal preoperative EF who underwent NSRP at 50 centres from nine European countries and Canada.Interventions
1:1:1 randomisation to 9 mo of treatment with tadalafil 5 mg once daily, tadalafil 20 mg on demand, or placebo followed by a 6-wk DFW and 3-mo open-label tadalafil once daily (all patients).Outcome measurements and statistical analysis
Logistic regression, mixed-effects model for repeated measures, and analysis of covariance, adjusting for treatment, age, and country, were applied to IIEF-EF scores ≥22, SEP-3, and penile length.Results and limitations
Four hundred twenty-three patients were randomised to tadalafil once daily (n = 139), on demand (n = 143), and placebo (n = 141). The mean age was 57.9 yr of age (standard deviation: 5.58 yr); 20.9%, 16.9%, and 19.1% of patients in the tadalafil once daily, on demand, and placebo groups, respectively, achieved IIEF EF scores ≥22 after DFW; odds ratios for tadalafil once daily and on demand versus placebo were 1.1 (95% confidence interval [CI], 0.6–2.1; p = 0.675) and 0.9 (95% CI, 0.5–1.7; p = 0.704). At the end of double-blind treatment (EDT), least squares (LS) mean IIEF-EF score improvement significantly exceeded the minimally clinically important difference (MCID: ΔIIEF-EF ≥4) in both tadalafil groups; for SEP-3 (MCID ≥ 23%), this was the case for tadalafil once daily only. Treatment effects versus placebo were significant for tadalafil once daily only (IIEF-EF: p = 0.016; SEP-3: p = 0.019). In all groups, IIEF-EF and SEP-3 decreased during DFW but continued to improve during open-label treatment. At month 9 (EDT), penile length loss was significantly reduced versus placebo in the tadalafil once daily group only (LS mean difference 4.1 mm; 95% CI, 0.4–7.8; p = 0.032).Conclusions
Tadalafil once daily was most effective on drug-assisted EF in men with erectile dysfunction following NSRP, and data suggest a potential role for tadalafil once daily provided early after surgery in contributing to the recovery of EF after prostatectomy and possibly protecting from penile structural changes. Unassisted EF was not improved after cessation of active therapy for 9 mo.Trial registration
ClinicalTrials.gov identifier NCT01026818. 相似文献15.
Sun M Thuret R Abdollah F Lughezzani G Schmitges J Tian Z Shariat SF Montorsi F Patard JJ Perrotte P Karakiewicz PI 《European urology》2011,59(1):135-141
Background
The rising incidence of renal cell carcinoma (RCC) has been largely attributed to the increasing use of imaging procedures.Objective
Our aim was to examine stage-specific incidence, mortality, and survival trends of RCC in North America.Design, setting, and participants
We computed age-adjusted incidence, survival, and mortality rates using the Surveillance Epidemiology and End Results database. Between 1988 and 2006, 43 807 patients with histologically confirmed RCC were included.Measurements
We calculated incidence, mortality, and 5-yr survival rates by year. Reported findings were stratified according to disease stage.Results and limitations
Age-adjusted incidence rate of RCC rose from 7.6 per 100 000 person-years in 1988 to 11.7 in 2006 (estimated annual percentage change [EAPC]: +2.39%; p < 0.001). Stage-specific age-adjusted incidence rates increased for localized stage: 3.8 in 1988 to 8.2 in 2006 (EAPC: +4.29%; p < 0.001) and decreased during the same period for distant stage: 2.1 to 1.6 (EAPC: −0.57%; p = 0.01). Stage-specific survival rates improved over time for localized stage but remained stable for regional and distant stages. Mortality rates varied significantly over the study period among localized stage, 1.3 in 1988 to 2.4 in 2006 (EAPC: +3.16%; p < 0.001), and distant stage, 1.8 in 1988 to 1.6 in 2006 (EAPC: −0.53%; p = 0.045). Better detailed staging information represents a main limitation of the study.Conclusions
The incidence rates of localized RCC increased rapidly, whereas those of distant RCC declined. Mortality rates significantly increased for localized stage and decreased for distant stage. Innovation in diagnosis and management of RCC remains necessary. 相似文献16.
Hanna N Sun M Trinh QD Hansen J Bianchi M Montorsi F Shariat SF Graefen M Perrotte P Karakiewicz PI 《European urology》2012,61(4):715-721
Background
Nephroureterectomy (NU) represents the primary management for patients with nonmetastatic upper tract urothelial carcinoma (UTUC). Either an open NU (ONU) or a laparoscopic NU (LNU) may be considered. Despite the presence of several reports comparing perioperative and cancer-control outcomes between the two approaches, no reports relied on a population-based cohort.Objectives
Examine intraoperative and postoperative morbidity of ONU and LNU in a population-based cohort.Design, setting, and participants
We relied on the US Nationwide Inpatient Sample (NIS) to identify patients with nonmetastatic UTUC treated with ONU or LNU between 1998 and 2009. Overall, 7401 (90.8%) and 754 (9.2%) patients underwent ONU and LNU, respectively. To adjust for potential baseline differences between the two groups, propensity-score-based matching was performed. This resulted in 3016 (80%) ONU patients matched to 754 (20%) LNU patients.Intervention
All patients underwent NU.Measurements
The rates of intra- and postoperative complications, blood transfusions, prolonged length of stay (pLOS), and in-hospital mortality were assessed for both procedures. Multivariable logistic regression analyses were performed within the cohort after propensity-score matching.Results and limitations
For ONU versus LNU respectively, the following rates were recorded: blood transfusions, 15% versus 10% (p < 0.001); intraoperative complications, 4.7% versus 2.1% (p = 0.002); postoperative complications, 17% versus 15% (p = 0.24); pLOS (≥5 d), 47% versus 28% (p < 0.001); in-hospital mortality, 1.3% versus 0.7% (p = 0.12). In multivariable logistic regression analyses, LNU patients were less likely to receive a blood transfusion (odds ratio [OR]: 0.6; p < 0.001), to experience any intraoperative complications (OR: 0.4; p = 0.002), and to have a pLOS (OR: 0.4; p < 0.001). Overall, postoperative complications were equivalent. However, LNU patients had fewer respiratory complications (OR: 0.4; p = 0.007). This study is limited by its retrospective nature.Conclusions
After adjustment for potential selection biases, LNU is associated with fewer adverse intra- and perioperative outcomes than ONU. 相似文献17.
Background
Long-term comparative outcomes for radiofrequency ablation (RFA) versus partial nephrectomy (PN) for the primary treatment of clinical T1a renal cell carcinoma (RCC) have not previously been reported.Objective
Report comparative 5-yr oncologic outcomes for RFA versus PN in patients with clinical T1a RCC.Design, setting, and participants
Observational single-institution cohort study, involving consecutive patients with a solitary histologically confirmed T1a RCC treated by RFA or PN and followed for a minimum of 5 yr. Those presenting with synchronous multiple, metachronous, bilateral, and/or metastatic disease, a history of hereditary RCC syndromes, a family history of RCC, and with post-treatment follow-up <5 yr were excluded from analysis.Measurements
The Kaplan-Meier method was used to determine 5-yr overall survival (OS), cancer-specific survival (CSS), local recurrence-free survival (local RFS), overall disease-free survival (DFS), and metastasis-free survival (MFS) for RFA versus PN. Survival curves were compared using the log-rank test. A p value ≤0.05 was considered statistically significant.Results and limitations
A total of 37 patients in each group met the selection criteria. The RFA cohort was significantly older and had more advanced comorbidities, but other patient characteristics were similar. For RFA versus PN, median follow-up was 6.5 yr (interquartile range [IQR]: 5.8–7.1) versus 6.1 yr (IQR: 5.4–7.3) (p = 0.68), respectively. The 5-yr OS was 97.2% versus 100% (p = 0.31), CSS was 97.2% versus 100% (p = 0.31), DFS was 89.2% versus 89.2% (p = 0.78), local RFS was 91.7% versus 94.6% (p = 0.96), and MFS was 97.2% versus 91.8% (p = 0.35), respectively. Study limitations are retrospective data analysis, loss to follow-up, limited statistical power, and limited generalizability of our data.Conclusions
In appropriately selected patients, RFA is an effective minimally invasive therapy for the treatment of cT1a RCC, yielding comparable long-term oncologic outcomes to nephron-sparing surgery. 相似文献18.
Background
A 23% relative risk reduction (RRR) in prostate cancer (PCa) was shown in men receiving dutasteride in the 4-yr Reduction by Dutasteride of Prostate Cancer Events study, in whom biopsies were protocol dependent.Objective
Our aim was to explore PCa risk reduction in men with benign prostatic hyperplasia (BPH) from the Combination of Avodart and Tamsulosin (CombAT) study, in which biopsies were undertaken for cause.Design, setting, and participants
CombAT was a 4-yr randomized double-blind parallel group study in 4844 men ≥50 yr of age with clinically diagnosed moderate to severe BPH, International Prostate Symptom Score ≥12, prostate volume ≥30 ml, and serum prostate-specific antigen (PSA) 1.5–10 ng/ml. Men underwent annual PSA measurement and digital rectal examination (DRE), and prostate biopsies were performed for cause.Intervention
All patients took tamsulosin 0.4 mg/d, dutasteride 0.5 mg/d, or a combination of both.Measurements
The primary end point was incidence of PCa. Secondary end points included postbaseline prostate biopsy rates and Gleason score of cancers.Results and limitations
Dutasteride (alone or in combination with tamsulosin) was associated with a 40% RRR of PCa diagnosis compared with tamsulosin monotherapy (95% confidence interval, 16–57%; p = 0.002) and a 40% reduction in the likelihood of biopsy. There were similar reductions in low- and high-grade Gleason score cancers. The biopsy rate in the groups receiving dutasteride trended toward a higher diagnostic yield (combination: 29%, dutasteride: 28%, tamsulosin: 24%). One limitation was the lack of a standardized approach to PCa diagnosis and grading.Conclusions
Dutasteride, alone or in combination with tamsulosin, significantly reduced the relative risk of PCa diagnosis in men with BPH undergoing annual DRE and PSA screening. Consistent with the increased usefulness of PSA for PCa detection, men receiving dutasteride had a numerically lower biopsy rate and higher yield of PCa on biopsy.Trial registration
Clinicaltrials.gov identifier: NCT00090103 (http://www.clinicaltrials.gov/ct2/show/NCT00090103). 相似文献19.
Manecksha RP Cullen IM Ahmad S McNeill G Flynn R McDermott TE Grainger R Thornhill JA 《European urology》2012,61(5):928-935
Background
Botulinum toxin A is effective for treatment of idiopathic detrusor overactivity (IDO). The trigone is generally spared because of the theoretical risk of vesicoureteric reflux (VUR), although studies assessing injection sites are lacking.Objective
Evaluate efficacy and safety of trigone-including versus trigone-sparing intradetrusor injections of abobotulinumtoxinA in patients with IDO.Design, setting, and participants
Twenty-two patients from one centre were randomised to trigone-including or trigone-sparing injections.Intervention
Injection of 500 U abobotulinumtoxinA diluted to 20 ml into 20 trigone-including or trigone-sparing sites.Measurements
The primary outcome measure was total overactive bladder symptom score (OABSS) at 6 wk. The OABSS questionnaire was completed at 0, 6, 12, and 26 wk. Baseline and postinjection urodynamic studies and micturating cystourethrograms were performed. Baseline values and subsequent time points were compared by t test. A mixed-effect model was used for repeated measures in time.Results and limitations
For symptom scores at baseline compared with scores at 6 wk postinjection, the mean total OABSS improved from 22.4 to 8.7 (p < 0.001) in the trigone-including group compared with 22.7 to 13.4 (p < 0.03) in the trigone-sparing group. The difference in mean change from baseline was 4.4 points in favour of the trigone-including group (p = 0.03). The total OABSS at 12 and 26 wk and the urgency subscale scores at 6, 12, and 26 wk showed significant improvement in favour of the trigone-including group. Mean postvoid residual volumes and clean intermittent self-catheterisation rates between the two groups were similar. No patients developed VUR. Performing injections under general anaesthetic was a limitation, as tolerability under local anaesthetic was not assessed. A further limitation is the lack of a trigone-only arm.Conclusions
Trigone-including injections are superior to trigone-sparing injections for the treatment of refractory IDO and did not cause VUR in this study. 相似文献20.