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

NCT ID: NCT00710749

Last Updated: 2021-11-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Outlet Obstruction Lower Urinary Tract Symptoms

Keywords

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Lower urinary tract symptoms leading to lower flow rates

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Disposable device first, then Digital device

Group Type EXPERIMENTAL

Disposable device

Intervention Type DEVICE

Disposable urine flow meter

Digital device

Intervention Type DEVICE

Digital urine flowmeter

Clinic flow measurement

Intervention Type DEVICE

Clinic gold standard flow measurement

Digital device first, then Disposable device

Group Type EXPERIMENTAL

Disposable device

Intervention Type DEVICE

Disposable urine flow meter

Digital device

Intervention Type DEVICE

Digital urine flowmeter

Clinic flow measurement

Intervention Type DEVICE

Clinic gold standard flow measurement

Interventions

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Disposable device

Disposable urine flow meter

Intervention Type DEVICE

Digital device

Digital urine flowmeter

Intervention Type DEVICE

Clinic flow measurement

Clinic gold standard flow measurement

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Wellspect HealthCare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Magnus Jacobsson, Prof.

Role: STUDY_CHAIR

Dentsply Sirona Implants and Consumables

Locations

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David Geffen school of Medicine at UCLA, Department of Urology

Los Angeles, California, United States

Site Status

UMC ST Radboud Nijmegen, Department of Urology

Nijmegen, , Netherlands

Site Status

Klinika Urology, Akademi Medycznej

Warsaw, , Poland

Site Status

Clinical Research Unit, Morriston Hospital, Swansea NHS Trust

Swansea, , United Kingdom

Site Status

Countries

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United States Netherlands Poland United Kingdom

Other Identifiers

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YA-FLO-0001

Identifier Type: -

Identifier Source: org_study_id