Trial Outcomes & Findings for Real World Data on Management of Male LUTS (NCT NCT03075449)

Results Overview

The percentage of men who have been given at least one prescription medication for urinary symptoms. This included any medications prescribed by PCP for urinary symptoms according to medical records within 12 months prior to telephone survey as described below: 1. Medications already prescribed by PCP for urinary symptoms prior to the 1st visit/contact for urinary symptoms within 12 months prior to telephone survey. 2. Medications newly prescribed by PCP upon visit(s)/contact(s) for urinary symptoms within 12 months prior to telephone survey (i.e., medications prescribed for urinary symptoms on or after the 1st visit/contact). 95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.

Recruitment status

COMPLETED

Target enrollment

201 participants

Primary outcome timeframe

12 months

Results posted on

2020-03-26

Participant Flow

A cross-sectional participant survey study combined with 12 months of retrospective data collection from participant's PCP medical records.

Participant milestones

Participant milestones
Measure	Participant Data Reported by Telephone Survey + Medical Record Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms
Overall Study STARTED	170
Overall Study COMPLETED	170
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Real World Data on Management of Male LUTS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participant Data Reported by Telephone Survey + Medical Record n=170 Participants Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms
Age, Continuous	62.1 Years STANDARD_DEVIATION 10.40 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	170 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Full Analysis Set (FAS): The FAS consists of all enrolled men whose PCP has provided their medical record with at least one urinary symptom recorded between 15 days and 12 months prior to telephone survey interview.

The percentage of men who have been given at least one prescription medication for urinary symptoms. This included any medications prescribed by PCP for urinary symptoms according to medical records within 12 months prior to telephone survey as described below: 1. Medications already prescribed by PCP for urinary symptoms prior to the 1st visit/contact for urinary symptoms within 12 months prior to telephone survey. 2. Medications newly prescribed by PCP upon visit(s)/contact(s) for urinary symptoms within 12 months prior to telephone survey (i.e., medications prescribed for urinary symptoms on or after the 1st visit/contact). 95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.

Outcome measures

Outcome measures
Measure	Participant Data Reported by Telephone Survey + Medical Record n=84 Participants Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms
The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records	35.7 Percentage of participants Interval 25.6 to 46.9

SECONDARY outcome

Timeframe: 12 months

Population: FAS

The percentage of men who received a medical diagnosis for their urinary symptoms, as recorded in their medical records. 95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.

Outcome measures

Outcome measures
Measure	Participant Data Reported by Telephone Survey + Medical Record n=84 Participants Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms
The Percentage of Men Who Received a Medical Diagnosis for Their Urinary Symptoms, as Recorded in Their Medical Records.	79.8 Percentage of participants Interval 69.6 to 87.7

SECONDARY outcome

Timeframe: 12 months

Population: FAS

The percentage of men with a diagnostic testing procedure ordered or performed specifically for their urinary symptoms. 95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.

Outcome measures

Outcome measures
Measure	Participant Data Reported by Telephone Survey + Medical Record n=84 Participants Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms
The Percentage of Men With a Diagnostic Testing Procedure Ordered or Performed Specifically for Their Urinary Symptoms.	61.9 Percentage of participants Interval 50.7 to 72.3

SECONDARY outcome

Timeframe: 12 months

Population: FAS

The percentage of men diagnosed with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) (enlarged prostate). 95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.

Outcome measures

Outcome measures
Measure	Participant Data Reported by Telephone Survey + Medical Record n=84 Participants Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms
The Percentage of Men Diagnosed With LUTS/BPH (Enlarged Prostate).	42.9 Percentage of participants Interval 32.1 to 54.1

SECONDARY outcome

Timeframe: 12 months

Population: FAS

The percentage of men referred to a urologist for their urinary symptoms. 95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.

Outcome measures

Outcome measures
Measure	Participant Data Reported by Telephone Survey + Medical Record n=84 Participants Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms
The Percentage of Men Referred to a Urologist for Their Urinary Symptoms.	48.8 Percentage of participants Interval 37.7 to 60.0

SECONDARY outcome

Timeframe: 12 months

Population: FAS

The percentage of men given a prescription for an alpha-blocker for their urinary symptoms. 95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.

Outcome measures

Outcome measures
Measure	Participant Data Reported by Telephone Survey + Medical Record n=84 Participants Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms
The Percentage of Men Given a Prescription for an Alpha-blocker for Their Urinary Symptoms.	26.2 Percentage of participants Interval 17.2 to 36.9

SECONDARY outcome

Timeframe: 12 months

Population: FAS

The percentage of men given repeat prescriptions for their urinary symptoms. 95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.

Outcome measures

Outcome measures
Measure	Participant Data Reported by Telephone Survey + Medical Record n=84 Participants Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms
The Percentage of Men Given Repeat Prescriptions for Their Urinary Symptoms.	33.3 Percentage of participants Interval 23.4 to 44.5

SECONDARY outcome

Timeframe: 12 months

Population: FAS

The number of urinary-symptom related visits to their primary care provider (PCP) during the 12 month period prior to telephone survey interview.

Outcome measures

Outcome measures
Measure	Participant Data Reported by Telephone Survey + Medical Record n=84 Participants Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms
The Number of Urinary-symptom Related Visits to Their PCP During the 12 Month Period Prior to Telephone Survey Interview.	1.8 urinary symptom-related visits Standard Deviation 1.24

Adverse Events

Participant Data Reported by Telephone Survey + Medical Record

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER