Observational Study in Patients Suffering From Benign Prostatic Hyperplasia Treated With Alpha-adrenergic Blockade

The primary objective of this observational study was the assessment of prognosis factors for having recourse to prostatic surgery in patients with BPH who were administered class-1 alpha blockers. The secondary objectives were the assessment of the time from alpha-adrenergic blockade treatment initiation to surgery and the evolution of patients during the study.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Any patient with BPH for whom alpha-blocker treatment is indicated
Patients who are already on class-1 alpha-blockers can only participate in the study if all information required is known and/or available

Exclusion criteria

Patient's follow-up not possible
Patients participating in another study
History of BPH surgery
Prostate cancer

Treatment and study plan

Alpha-adrenergic blocker

Drug

Primary outcomes

Assessment of prognosis factors for having recourse to prostatic surgery

Time frame: up to 2 years

Secondary outcomes

Time form alpha-adrenergic blockade treatment initiation to surgery

Time frame: up to 2 years
Occurrence of concomitant BPH diseases

Time frame: up to 2 years
Total International Prostate Symptom Score (IPSS)

Time frame: up to 2 years
Percentage of patients with ongoing BPH treatment

Time frame: up to 2 years

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Evolution of Patients Suffering From Benign Prostatic Hyperplasia (BPH) Treated With Alpha-adrenergic Blockade (JOSEPHINE)

Important dates

Study start: 2000
Primary completion: 2003
First posted: Sep 19, 2014
Registry last updated: Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed