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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02244307
Recruitment Status : Completed
First Posted : September 19, 2014
Last Update Posted : September 19, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment
Prostatic Hyperplasia Drug: alpha-adrenergic blocker

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Study Type : Observational
Actual Enrollment : 4561 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evolution of Patients Suffering From Benign Prostatic Hyperplasia (BPH) Treated With Alpha-adrenergic Blockade (JOSEPHINE)
Study Start Date : January 2000
Actual Primary Completion Date : June 2003

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients with BPH treated with alpha-andrenergic blockade Drug: alpha-adrenergic blocker

Primary Outcome Measures :
  1. Assessment of prognosis factors for having recourse to prostatic surgery [ Time Frame: up to 2 years ]

Secondary Outcome Measures :
  1. Time form alpha-adrenergic blockade treatment initiation to surgery [ Time Frame: up to 2 years ]
  2. Occurrence of concomitant BPH diseases [ Time Frame: up to 2 years ]
  3. Total International Prostate Symptom Score (IPSS) [ Time Frame: up to 2 years ]
  4. Percentage of patients with ongoing BPH treatment [ Time Frame: up to 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with BPH for whom alpha-blockade treatement is indicated recruited at general practitioners

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

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02244307     History of Changes
Other Study ID Numbers: 527.28
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs