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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,342

participants targeted

Target at P75+ for all trials

Geographic Reach

1 country

18 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2009

Completed

1 month until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed

1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed

20 days until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed

Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

1 month

First QC Date

January 20, 2009

Last Update Submit

November 13, 2013

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

Reductions in the intensity of symptoms, evaluated using the IPSS scale.
up to 90 days
Improvement in quality of life, measured using the NQoL questionnaire.
up to 90 days

Eligibility Criteria

Age40 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

men \>=40 years old with BPH

You may qualify if:

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.

You may not qualify if:

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
Acute Urinary Retention (AUR)
Urinary tract infection
Renal failure

Contact the study team to confirm eligibility.