Clinical trial NCT00885027: MEN STUDY (ESTUDIO MEN) Quality of Life in Patients With BPH and Nocturia Before and After Tamsulosin Ocas® Treatment
Official title: Quality of Life in Patients With BPH and Nocturia Before and After Tamsulosin Ocas® Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-04-21
Enrollment: 1342
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: men \>=40 years old with BPH

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:

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

Primary outcomes:
measure: Reductions in the intensity of symptoms, evaluated using the IPSS scale.
timeFrame: up to 90 days
measure: Improvement in quality of life, measured using the NQoL questionnaire.
timeFrame: up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Bogotá
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Boyacá
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Bucaramanga
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Cali
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Cartagena
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Cúcuta
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Ibagué
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Manizales
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Medellín
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Palmira
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Pereira
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Popayán
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Santa Marta
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Sincelejo
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Tulua
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Valledupar
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Villavicencio
country: Colombia
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: