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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03179670
Recruitment Status : Not yet recruiting
First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Information provided by (Responsible Party):
Laboratoires Bouchara-Recordati

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.

Condition or disease
Benign Prostatic Hyperplasia

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
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
Anticipated Study Start Date : June 15, 2017
Estimated Primary Completion Date : October 30, 2017
Estimated Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  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. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03179670

Contact: catherine koch +33 1 45 19 11 03

Sponsors and Collaborators
Laboratoires Bouchara-Recordati

Responsible Party: Laboratoires Bouchara-Recordati Identifier: NCT03179670     History of Changes
Other Study ID Numbers: KMD 3213-FR-NIS-0019
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms