NCT02244307

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,561

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
11.3 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

3.4 years

First QC Date

September 18, 2014

Last Update Submit

September 18, 2014

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Assessment of prognosis factors for having recourse to prostatic surgery

    up to 2 years

Secondary Outcomes (4)

  • 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

Study Arms (1)

Patients with BPH treated with alpha-andrenergic blockade

Drug: alpha-adrenergic blocker

Interventions

alpha-adrenergic blockerDRUG
Patients with BPH treated with alpha-andrenergic blockade

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with BPH for whom alpha-blockade treatement is indicated recruited at general practitioners

You may qualify if:

  • 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

You may not qualify if:

  • Patient's follow-up not possible
  • Patients participating in another study
  • History of BPH surgery
  • Prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Adrenergic alpha-Antagonists

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Adrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2014

First Posted

September 19, 2014

Study Start

January 1, 2000

Primary Completion

June 1, 2003

Last Updated

September 19, 2014

Record last verified: 2014-09