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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02244307
Enrollment
4561
Registered
2014-09-19
Start date
2000-01-31
Completion date
Unknown
Last updated
2014-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia

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.

Interventions

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Assessment of prognosis factors for having recourse to prostatic surgeryup to 2 years

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026