Trial Outcomes & Findings for The Value of Multiple Urine Flow Rate Measurements in Male Benign Prostatic Hyperplasia (BPH) Subjects (NCT NCT00710749)

NCT ID: NCT00710749

Last Updated: 2021-11-11

Results Overview

Measurements with a disposable device and the current clinic gold standard measurement were compared to test the hypothesis that three repeated measurements with the disposable device was as accurate as one clinic flow measurement. A digital device was used as a reference of the most exact way to evaluate each patient's individual flow.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: At every voiding event during approximately one week.
• Results posted on: 2021-11-11

Participant Flow

Participant milestones

Measure	Disposable Device First, Then Digital Device 12 voidings recorded with the disposable device in the first intervention period, followed by 12 voidings recorded with the digital device in the second intervention period.	Digital Device First, Then Disposable Device 12 voidings recorded with the digital device in the first intervention period, followed by 12 voidings recorded with the disposable device in the second intervention period.
Clinic Baseline Recording STARTED	30	30
Clinic Baseline Recording COMPLETED	30	30
Clinic Baseline Recording NOT COMPLETED	0	0
First Intervention STARTED	30	30
First Intervention COMPLETED	29	30
First Intervention NOT COMPLETED	1	0
Second Intervention STARTED	29	30
Second Intervention COMPLETED	29	30
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Disposable Device First, Then Digital Device 12 voidings recorded with the disposable device in the first intervention period, followed by 12 voidings recorded with the digital device in the second intervention period.	Digital Device First, Then Disposable Device 12 voidings recorded with the digital device in the first intervention period, followed by 12 voidings recorded with the disposable device in the second intervention period.
First Intervention Withdrawal by Subject	1	0

Baseline Characteristics

The Value of Multiple Urine Flow Rate Measurements in Male Benign Prostatic Hyperplasia (BPH) Subjects

Baseline characteristics by cohort

Measure	Entire Study Population n=60 Participants Includes groups randomized to use the Disposable device first and the Digital device first.
Age, Continuous	66 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants
Region of Enrollment Poland	16 participants n=5 Participants
Region of Enrollment Netherlands	13 participants n=5 Participants
Region of Enrollment United Kingdom	29 participants n=5 Participants

PRIMARY outcome

Timeframe: At every voiding event during approximately one week.

Population: Intention to treat analysis. Number of participants analyzed differs between groups since data was missing mainly due to technical problems.

Measurements with a disposable device and the current clinic gold standard measurement were compared to test the hypothesis that three repeated measurements with the disposable device was as accurate as one clinic flow measurement. A digital device was used as a reference of the most exact way to evaluate each patient's individual flow.

Outcome measures

Measure	Disposable Device n=57 Participants Voidings recorded with the disposable device in either first intervention period or second intervention period.	Clinic n=59 Participants Voidings recorded with the clinic gold standard.	Digital Device n=52 Participants Voidings recorded with the digital device in either first intervention period or second intervention period.
Mean Urine Flow Rate	12 ml/s Standard Deviation 4	13 ml/s Standard Deviation 7	16 ml/s Standard Deviation 8

Adverse Events

Disposable Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clinic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Digital Device

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

Head of Clinical Research Area Health Care

Astra Tech AB

Phone: +46317763000

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60