Status:
COMPLETED
MEN STUDY (ESTUDIO MEN) Quality of Life in Patients With BPH and Nocturia Before and After Tamsulosin Ocas® Treatment
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Prostatic Hyperplasia
Eligibility:
MALE
40+ years
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...
Detailed Description
Study Design:
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1342 Patients enrolled
Trial Details
Trial ID
NCT00885027
Start Date
March 1 2009
Last Update
November 14 2013
Active Locations (18)
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1
Boehringer Ingelheim Investigational Site
Barranquilla, Colombia
2
Boehringer Ingelheim Investigational Site
Bogotá, Colombia
3
Boehringer Ingelheim Investigational Site
Boyacá, Colombia
4
Boehringer Ingelheim Investigational Site
Bucaramanga, Colombia