Observational Study in Patients Suffering From Benign Pro... | NCT02244307

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

NCT02244307

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 19, 2014Estimated

Enrollment

4,561Actual

Phase

Not provided

Conditions

Prostatic Hyperplasia

Interventions

alpha-adrenergic blocker

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2000

Primary Completion Date

Jun 2003Actual

Completion Date

Not provided

First Submitted Date

Sep 18, 2014

First Submission Date that Met QC Criteria

Sep 18, 2014

First Posted Date

Sep 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2014

Last Update Posted Date

Sep 19, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,561Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with BPH treated with alpha-andrenergic blockade			Drug: alpha-adrenergic blocker

Interventions

Name	Type	Description	Arm Group Labels	Other Names
alpha-adrenergic blocker	Drug		Patients with BPH treated with alpha-andrenergic blockade

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of prognosis factors for having recourse to prostatic surgery		up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000317	Adrenergic alpha-Antagonists

Ancestor Terms

ID	Term
D018674	Adrenergic Antagonists
D018663	Adrenergic Agents
D018377	Neurotransmitter Agents
D045504	Molecular Mechanisms of Pharmacological Action

Browse Leaves

Not provided

Browse Branches

Not provided