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MEN STUDY (ESTUDIO MEN) Quality of Life in Patients With BPH and Nocturia Before and After Tamsulosin Ocas® Treatment
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, July 2009
First Received: January 20, 2009   Last Updated: July 27, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00885027
  Purpose

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

Condition
Prostatic Hyperplasia

Study Type: Observational
Study Design: Prospective
Official Title: Quality of Life in Patients With BPH and Nocturia Before and After Tamsulosin Ocas® Treatment

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Improvement in terms of quality of life (QoL) [ Time Frame: 9 months ]

Secondary Outcome Measures:
  • severity of the low tract urinary symptoms and the quality of life by means of IPSS questionnaire application. [ Time Frame: 9 months ]

Estimated Enrollment: 784
Study Start Date: March 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Study Design:

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

men >=40 years old with BPH

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885027

Contacts
Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Colombia
Boehringer Ingelheim Investigational Site Recruiting
Bogotá, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Cali, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Medellín, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Barranquilla, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Bucaramanga, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Cartagena, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Boyacá, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Ibagué, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Villavicencio, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Palmira, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Pereira, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Popayán, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Santa Marta, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Sincelejo, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Tulua, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Valledupar, Colombia
Boehringer Ingelheim Investigational Site Recruiting
Manizales, Colombia
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 527.80
Study First Received: January 20, 2009
Last Updated: July 27, 2009
ClinicalTrials.gov Identifier: NCT00885027     History of Changes
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Study placed in the following topic categories:
Hyperplasia
Nocturia
Prostatic Diseases
Prostatic Hyperplasia
Tamsulosin
Quality of Life
Genital Diseases, Male

Additional relevant MeSH terms:
Hyperplasia
Pathologic Processes
Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

ClinicalTrials.gov processed this record on August 24, 2009