Interest of a Systematic Assessment of the Treatment of LUTS in the Management of BPH (UROEVAL)

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

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia

• Study Type: Observational
• Enrollment (Actual): 625

Contacts and Locations

Study Locations

• France
  • Puteaux, France
    • LBR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Laboratoires Bouchara-Recordati
• Collaborators: ClinSearch

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: KMD 3213-FR-NIS-0019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO