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

Prostatic Hyperplasia Clinical Trial

Official title:

Quality of Life in Patients With BPH and Nocturia Before and After Tamsulosin Ocas® Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885027
• Other study ID #: 527.80
• Status: Completed
• Phase: N/A
• First received: January 20, 2009
• Last updated: November 13, 2013
• Start date: March 2009

Study information

• Verified date: November 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Observational

Clinical Trial 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

Description:

Study Design:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1342
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reductions in the intensity of symptoms, evaluated using the IPSS scale.		up to 90 days	No
Primary	Improvement in quality of life, measured using the NQoL questionnaire.		up to 90 days	No