ABSTRACT
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 80mg 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.
Subject(s)
Adrenergic Uptake Inhibitors/therapeutic use , Prostatectomy/adverse effects , Selective Serotonin Reuptake Inhibitors/therapeutic use , Thiophenes/therapeutic use , Urinary Incontinence/prevention & control , Adrenergic Uptake Inhibitors/adverse effects , Aged , Aged, 80 and over , Chi-Square Distribution , Double-Blind Method , Duloxetine Hydrochloride , Humans , Male , Middle Aged , Paris , Pilot Projects , Placebo Effect , Prospective Studies , Quality of Life , Selective Serotonin Reuptake Inhibitors/adverse effects , Surveys and Questionnaires , Thiophenes/adverse effects , Time Factors , Treatment Outcome , Urinary Incontinence/etiologyABSTRACT
The new legislation concerning biomedical research entered into force on 28 August 2006. This legislation, which goes further than the recommendations of European Directive 2001/20/EC, introduces several modifications reinforcing the role of the Comité de Protection des Personnes (Ethics Committee) and the various administrations. The protection of subjects is reinforced by increased control of participants and investigators. Publication of lists of authorized research is designed to strengthen European research. The authors propose a summary of the new legislation to facilitate preparation of protocols.
Subject(s)
Biomedical Research/legislation & jurisprudence , Biomedical Research/methods , FranceABSTRACT
UNLABELLED: Although macroscopic haematuria during the month following transurethral resection of the prostate, due to sloughing of necrotic tissue, is a phenomenon well known to urologists since introduction of endoscopic resection, its pathophysiological and epidemiological characteristics are poorly defined. The objective of this retrospective study was to define the incidence of serious macroscopic haematuria after transurethral resection of the prostate (TURP) and to identify the risk factors for macroscopic haematuria. PATIENTS AND METHODS: The hospital database was used to identify patients treated by TURP between 1997 and 2004 and rehospitalized during the 31 days following the procedure. Files of patients presenting with haematuria and bladder clots were selected and analysed. RESULTS: Ten of a series of 624 patients undergoing TURP were hospitalised for bladder clots and their case files were analysed: median age: 72 years, median duration of TURP: 45 min and median weight of resection: 12 g. The operators' experience and the duration of post-TURP catheterization were not informative. In 2 cases, prostate cancer was diagnosed after analysis of resection chips. Two patients were treated by anticoagulants. Patients were essentially rehospitalized during the 2nd week (median: 11th day). A bladder catheter for was inserted for lavage in each case. No patient required reoperation or removal of clots under general anaesthesia. Two patients were transfused. CONCLUSION: We did not identify any risk factor for sloughing leading to macroscopic haematuria during the month following TURP. Macroscopic haematuria justifying rehospitalization is a rare event. However, in view of this low incidence, optimal analysis could only be performed in the context of a national prospective register.
