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

NCT03179670 | Completed

• 1 other identifier: KMD 3213-FR-NIS-0019
• Study Type: observational
• Target: 625
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RECORDATI GROUP: lead
• ClinSearch: collaborator

Study Sites (1)

LBR

Puteaux, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 7, 2017
• Study Start: June 15, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)