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

NCT02244307 — Completed, 4561 participants, Boehringer Ingelheim
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT02244307
StatusCompleted
Study typeObservational
Enrollment4561 (Actual)
SponsorBoehringer Ingelheim (Industry)
ConditionsProstatic Hyperplasia
Interventionsalpha-adrenergic blocker (Drug)
Datesstart 2000-01-01, primary completion 2003-06-01, first posted 2014-09-19, last updated 2014-09-19

Related Papers Related Patents Related Grants Related Experts
All trials for Prostatic Hyperplasia All trials of alpha-adrenergic blocker

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Patients with BPH treated with alpha-andrenergic blockadeDrug: alpha-adrenergic blocker
  • alpha-adrenergic blocker (Drug)

+Outcome measures

Primary outcomes

  • Assessment of prognosis factors for having recourse to prostatic surgery [up to 2 years]

Secondary outcomes

  • 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]
  • Percentage of patients with ongoing BPH treatment [up to 2 years]

+Eligibility

Sex: Male

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