Interest of a Systematic Assessment of the Treatment of LUTS in the Management of BPH (UROEVAL)
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The high level of unsatisfactory outcome observed in patients treated for LUTS associated with BPH with respect to the different existing therapeutic options strongly emphasizes the need for treatment optimisation in daily practice by a careful LUTS monitoring and treatment adjustment when needed. The poorer outcome observed in patients for whom treatment has been initiated recently suggests that the duration of the disease itself may influence the patient satisfaction.To achieve this goal, we propose to systematically assess LUTS associated with BPH in patients treated for at least 6 months and to assess whether an alpha-blocker therapy initiation/modification may improve the outcome in case of persisting symptoms. We also investigate the influence of the symptom duration on the frequency of unsatisfactory outcome.
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Layout table for eligibility information
Ages Eligible for Study:
60 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The frequency of patients with IPSS score <8 after three months of treatment with alpha-blockers is about 40%. The sample size required to detect a proportion of 40% with a precision of 0.04 is 550 patients. Based on a literature review of Lacoin et al, the frequency of treated patients with LUTS associated with BPH with an IPSS ≥ 8 is approximately 60%. Thus, 917 patients will be needed to obtain a sample of 550 patients with treatment of alpha-blockers (550/0.6 = 917).
Considering 10% of patients lost for follow-up or refusing treatment change, the total number required is estimated at about 1,000 patients.
Patients aged 60 years or more suffering from LUTS/BPH AND medically treated for at least 6 months.
Patients with prostate cancer
Patients requiring surgical treatment
The absence of Lower Urinary Tract Symptoms
Treatment initiation for less than 6 months
Cognitive disorders or other pathologies leading to the inability to give its consent to the collection of data.