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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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1342 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Brief Summary

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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

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Study Design:

Conditions

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Prostatic Hyperplasia

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Barranquilla, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Bogotá, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Boyacá, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Bucaramanga, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Cali, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Cartagena, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Cúcuta, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Ibagué, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Manizales, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Medellín, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Palmira, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Pereira, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Popayán, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Santa Marta, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Sincelejo, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Tuluá, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Valledupar, , Colombia

Site Status

Boehringer Ingelheim Investigational Site

Villavicencio, , Colombia

Site Status

Countries

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Colombia

Other Identifiers

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527.80

Identifier Type: -

Identifier Source: org_study_id