Real World Data on Management of Male LUTS

NCT ID: NCT03075449

Last Updated: 2020-03-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-19

Study Completion Date

2016-12-21

Brief Summary

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This study will describe the current medical care given to men who discuss their lower urinary tract symptoms with a HCP. It will document the primary reasons for the visit, the baseline characteristics of these men, the treatment received, and the practice patterns of specifically a primary care physician managing these patients.

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Males, aged ≥18 years old.
* Having had discussion of urinary symptoms with their PCP between 15 days and 12 months prior to the date of the phone interview.
* Able to read, speak and understand English.
* Willing to provide informed consent for study participation, authorize the release of their previous 12-month medical records from their PCP for review and de-identified data entry by Mapi into an electronic study database.

Exclusion Criteria

* Reported during screening that they had had their first-ever discussion of urinary symptoms with PCP within the 14 days prior to the date of the phone interview.
* Participation in a clinical research study that evaluated urinary symptoms in the past 12 months.
* Self-reported history of colorectal, bladder or prostate cancer.
* Self-reported neurologic disorders that affect bladder function, e.g., neurogenic bladder disorders due to spinal cord injury/disease, multiple sclerosis, Parkinsons disease.
* Self-reported history of radiation therapy to the lower abdominal and/or pelvic region.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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527.87.10001 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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527.87

Identifier Type: -

Identifier Source: org_study_id

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