MEN STUDY (ESTUDIO MEN) Quality of Life in Patients With BPH and Nocturia Before and After Tamsulosin Ocas® Treatment

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00885027
First received: January 20, 2009
Last updated: November 13, 2013
Last verified: November 2013
  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: Time Perspective: 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:

Primary Outcome Measures:
  • Reductions in the intensity of symptoms, evaluated using the IPSS scale. [ Time Frame: up to 90 days ] [ Designated as safety issue: No ]
  • Improvement in quality of life, measured using the NQoL questionnaire. [ Time Frame: up to 90 days ] [ Designated as safety issue: No ]

Enrollment: 1342
Study Start Date: March 2009
Primary Completion Date: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00885027     History of Changes
Other Study ID Numbers: 527.80
Study First Received: January 20, 2009
Last Updated: November 13, 2013
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

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

ClinicalTrials.gov processed this record on October 01, 2014