MEN STUDY (ESTUDIO MEN) Quality of Life in Patients With BPH and Nocturia Before and After Tamsulosin Ocas® Treatment
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatic Hyperplasia
Phase: N/A
Status: Recruiting
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals
Overall contact:
Boehringer Ingelheim Study Coordinator, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com
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
Clinical Details
Official title: Quality of Life in Patients With BPH and Nocturia Before and After Tamsulosin Ocas® Treatment
Study design: Other, Prospective
Primary outcome: Improvement in terms of quality of life (QoL)
Secondary outcome: severity of the low tract urinary symptoms and the quality of life by means of IPSS questionnaire application.
Detailed description:
Study Design:
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Boehringer Ingelheim Study Coordinator, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com
Boehringer Ingelheim Investigational Site, Bogotá, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Cali, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Medellín, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Barranquilla, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Bucaramanga, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Cartagena, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Boyacá, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Ibagué, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Manizales, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Palmira, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Pereira, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Popayán, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Santa Marta, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Sincelejo, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Tulua, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Valledupar, Colombia; Recruiting
Boehringer Ingelheim Investigational Site, Villavicencio, Colombia; Recruiting
Additional Information
Starting date: March 2009
Last updated: September 24, 2009
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