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NCT03179670 Clinical Trial

Interest of a Systematic Assessment of the Treatment of LUTS in the Management of BPH

Benign Prostatic Hyperplasia Clinical Trial

— UROEVAL  

Official title:
Interest of a Systematic Assessment of the Treatment of Lower Urinary Tract Symptoms (LUTS) in the Management of Benign Prostatic Hyperplasia (BPH) in Urology

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03179670
Other study ID # KMD 3213-FR-NIS-0019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2017
Est. completion date June 30, 2018

Study information
Verified date June 2019
Source Laboratoires Bouchara-Recordati
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 625
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender Male
Age group 60 Years and older
Eligibility Inclusion Criteria:

Patients aged 60 years or more suffering from LUTS/BPH AND medically treated for at least 6 months.

Exclusion Criteria:

- 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.

- Refusal to participate.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France LBR Puteaux

Sponsors (2)
Lead Sponsor Collaborator
Laboratoires Bouchara-Recordati ClinSearch

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients treated for LUTS associated with BPH displaying unsatisfactory outcome after at least 6 months of treatment and not requiring surgical treatment. 6 months
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