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

• Sponsor: Wellspect HealthCare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00710749
• Collaborator: (none)
• Enrollment: 60
• Locations: 4
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 15
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

Crossover comparison of different flow meters with a digital home flow meter as a reference. Main hypothesis: Reapeated home flow measurements with a disposable device will provide a better understanding of the patients urinary flow than a single measurement performed in the clinic.

Condition or Disease	Intervention/Treatment	Phase
Bladder Outlet Obstruction; Lower Urinary Tract Symptoms	Device: Disposable device; Device: Digital device; Device: Clinic flow measurement	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: An Open Prospective Multicenter Study Comparing the Urine Flow Measurements of Standard Clinic Flow Measurements vs Comercially Available Portable Digital Flow Meters and a Disposable Flow Meter in a Crossover and Randomized Order on Male BPH Subjects
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Disposable device first, then Digital device	Device: Disposable device; Disposable urine flow meter; Device: Digital device; Digital urine flowmeter; Device: Clinic flow measurement; Clinic gold standard flow measurement
Experimental: Digital device first, then Disposable device	Device: Disposable device; Disposable urine flow meter; Device: Digital device; Digital urine flowmeter; Device: Clinic flow measurement; Clinic gold standard flow measurement

Outcome Measures

Primary Outcome Measures

1. Mean Urine Flow Rate [At every voiding event during approximately one week.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 85 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Provision of informed consent

• Males aged 45-85 years

• 60% of the voiding volume is above 100 ml per voiding verified by a urinary diary

• Able to read write and understand given instructions

Exclusion Criteria:

• Patients practicing CIC

• Ongoing symptomatic UTI

• Known Neurological Disease that is affecting the bladder function

• Known past or present alcohol or drug abuse

• Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)

• Previous enrolment or randomisation of treatment in the present study.

• Suspected poor compliance based on less than 80 % compliance to voiding diary

• Severe non-compliance to protocol as judged by the investigator and/or Astra Tech

• On alpha-blocker or 5-alpha reductase inhibitor treatment, treatment started less than 2 months prior to enrolment

• Clinic flow below 100 ml

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	David Geffen school of Medicine at UCLA, Department of Urology	Los Angeles	California	United States	90095-1738
2	UMC ST Radboud Nijmegen, Department of Urology	Nijmegen		Netherlands	6500 HB
3	Klinika Urology, Akademi Medycznej	Warsaw		Poland	02005
4	Clinical Research Unit, Morriston Hospital, Swansea NHS Trust	Swansea		United Kingdom	SA6 6NL

Sponsors and Collaborators

• Wellspect HealthCare

Investigators

• Study Chair: Magnus Jacobsson, Prof., Dentsply Sirona Implants

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wellspect HealthCare
• ClinicalTrials.gov Identifier: NCT00710749
• Other Study ID Numbers: YA-FLO-0001
• First Posted: Jul 4, 2008
• Last Update Posted: Nov 11, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by Wellspect HealthCare: Lower urinary tract symptoms leading to lower flow rates
• Additional relevant MeSH terms: Urinary Bladder Neck Obstruction; Lower Urinary Tract Symptoms

Study Results

Participant Flow

Arm/Group Title	Disposable Device First, Then Digital Device	Digital Device First, Then Disposable Device
Arm/Group Description	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.	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.
Period Title: Clinic Baseline Recording
STARTED	30	30
COMPLETED	30	30
NOT COMPLETED	0	0
Period Title: Clinic Baseline Recording
STARTED	30	30
COMPLETED	29	30
NOT COMPLETED	1	0
Period Title: Clinic Baseline Recording
STARTED	29	30
COMPLETED	29	30
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	Includes groups randomized to use the Disposable device first and the Digital device first.
Overall Participants	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (9.8)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	60 100%
Region of Enrollment (participants) [Number]
United States	2 3.3%
Poland	16 26.7%
Netherlands	13 21.7%
United Kingdom	29 48.3%

Outcome Measures

1. Primary Outcome

Title	Mean Urine Flow Rate
Description	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.
Time Frame	At every voiding event during approximately one week.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Disposable Device	Clinic	Digital Device
Arm/Group Description	Voidings recorded with the disposable device in either first intervention period or second intervention period.	Voidings recorded with the clinic gold standard.	Voidings recorded with the digital device in either first intervention period or second intervention period.
Measure Participants	57	59	52
Mean (Standard Deviation) [ml/s]	12 (4)	13 (7)	16 (8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Disposable Device, Clinic
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	Wilcoxon signed rank test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Clinic, Digital Device
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Wilcoxon signed rank test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Disposable Device, Digital Device
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon signed rank test
	Comments

Adverse Events

Arm/Group Title	Disposable Device		Clinic		Digital Device
Arm/Group Description	Voidings recorded with the disposable device in either first intervention period or second intervention period.		Voidings recorded with the clinic gold standard.		Voidings recorded with the digital device in either first intervention period or second intervention period.
All Cause Mortality
	Disposable Device		Clinic		Digital Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Disposable Device		Clinic		Digital Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Disposable Device		Clinic		Digital Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)		0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.