MEN STUDY (ESTUDIO MEN) Quality of Life in Patients With BPH and Nocturia Before and After Tamsulosin Ocas® Treatment

NCT ID: NCT00885027

Last Updated: 2013-11-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1342 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-31

Brief Summary

This is an exploratory study, to evaluate the improvement in terms of quality of life that can be reached by a group of outpatients with BPH ( Benign Prostatic Hyperplasia ) and nocturia when they are under treatment with Secotex Ocas.

This study will explore, the progress in terms of quality of life that can be reached by a group of outpatients with BPH ( Benign Prostatic Hyperplasia) and nocturia treated with Secotex OCAS®.

This is a not controlled study, " before and after type", which will consist of an assessment, of the quality of life for outpatients with BPH symptoms including nocturia, through the use of the Spanish version of the Nocturia Quality-of-life (NQoL) questionnaire, at three different moments:

1. Before to start Secotex OCAS® treatment.

2. Thirty (30) days after first visit and starting Secotex OCAS® treatment

3. Ninethy (90) days after first visit and starting Secotex Ocas® treatment

Detailed Description

Study Design:

Conditions

Prostatic Hyperplasia

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Men 40 years old with benign prostatic hyperplasia (BPH) which, according their doctor, requires medical treatment to improve quality of life. Patients may be new in the treatment or can be treated with other medicines but not having responded adequately to treatment (Not should be taking Tamsulosin OCAS).

PSA < 4.0 ng/ml or 4 ¿ 10ng/ml with prior negative Transrectal biopsy. IPSS > 12 points. Two or more episodes of nocturia per night (score equal or exceed 2 in question 7 of IPSS).

IPSS QoL (Question 8) > 3 points (score equal or superior to 3 in question 8 of Quality of Life (QoL) of IPSS).

Acceptance written of their participation in the study by the informed consent. The decision of treatment should be based on the best clinical practice accepted standard and according to the information for prescription for Secotex OCAS® 0.4 mg.

Exclusion Criteria

Patients with clear indication to receive surgical treatment Hospitalized patients Patients with physical or mental disabilities that prevent, even with the help of doctor, completing the instruments of assessment of the survey Patients with a history of malignant disease Patients with known hypersensitivity to tamsulosin or to another component of the product Patients with a history of orthostatic hypotension or severe liver failure Positive digital rectal test for possible neoplasia or biochemical evidence of high PSA with figures > 4.0 ng/ml Patients with diastolic blood pressure less than 60 mmHg or tachycardia greater to 120 beats per minute

Other reasons for the exclusion:

• Acute Urinary Retention (AUR)
• Urinary tract infection
• Renal failure

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Boehringer Ingelheim Investigational Site

Barranquilla, , Colombia

Boehringer Ingelheim Investigational Site

Bogotá, , Colombia

Boehringer Ingelheim Investigational Site

Boyacá, , Colombia

Boehringer Ingelheim Investigational Site

Bucaramanga, , Colombia

Boehringer Ingelheim Investigational Site

Cali, , Colombia

Boehringer Ingelheim Investigational Site

Cartagena, , Colombia

Boehringer Ingelheim Investigational Site

Cúcuta, , Colombia

Boehringer Ingelheim Investigational Site

Ibagué, , Colombia

Boehringer Ingelheim Investigational Site

Manizales, , Colombia

Boehringer Ingelheim Investigational Site

Medellín, , Colombia

Boehringer Ingelheim Investigational Site

Palmira, , Colombia

Boehringer Ingelheim Investigational Site

Pereira, , Colombia

Boehringer Ingelheim Investigational Site

Popayán, , Colombia

Boehringer Ingelheim Investigational Site

Santa Marta, , Colombia

Boehringer Ingelheim Investigational Site

Sincelejo, , Colombia

Boehringer Ingelheim Investigational Site

Tuluá, , Colombia

Boehringer Ingelheim Investigational Site

Valledupar, , Colombia

Boehringer Ingelheim Investigational Site

Villavicencio, , Colombia

Countries

Colombia

Other Identifiers

527.80

Identifier Type: -

Identifier Source: org_study_id