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

Boehringer Ingelheim0 sites4,561 target enrollmentJanuary 2000

ConditionsProstatic Hyperplasia

Interventionsalpha-adrenergic blocker

Drugsalpha-adrenergic blocker

Overview

Phase: Not Applicable
Intervention: alpha-adrenergic blocker
Conditions: Prostatic Hyperplasia
Sponsor: Boehringer Ingelheim
Enrollment: 4561
Primary Endpoint: Assessment of prognosis factors for having recourse to prostatic surgery
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2000

End Date

June 2003

Last Updated

11 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Patients with BPH treated with alpha-andrenergic blockade

Intervention: alpha-adrenergic blocker

Outcomes

Primary Outcomes

Assessment of prognosis factors for having recourse to prostatic surgery

Time Frame: up to 2 years

Secondary Outcomes

Percentage of patients with ongoing BPH treatment(up to 2 years)
Time form alpha-adrenergic blockade treatment initiation to surgery(up to 2 years)
Occurrence of concomitant BPH diseases(up to 2 years)
Total International Prostate Symptom Score (IPSS)(up to 2 years)