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NCT02244307 Clinical Trial

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

Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02244307
Other study ID # 527.28
Secondary ID
Status Completed
Phase N/A
First received September 18, 2014
Last updated September 18, 2014
Start date January 2000

Study information
Verified date September 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority France: Conseil National de l'Ordre des Médecins
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 4561
Est. completion date
Est. primary completion date June 2003
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• alpha-adrenergic blocker

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of prognosis factors for having recourse to prostatic surgery up to 2 years No
Secondary Time form alpha-adrenergic blockade treatment initiation to surgery up to 2 years No
Secondary Occurrence of concomitant BPH diseases up to 2 years No
Secondary Total International Prostate Symptom Score (IPSS) up to 2 years No
Secondary Percentage of patients with ongoing BPH treatment up to 2 years No
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