NCT00710749

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Shorter than P25 for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

June 23, 2011

Completed
Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

July 3, 2008

Results QC Date

March 18, 2011

Last Update Submit

November 10, 2021

Conditions

Bladder Outlet ObstructionLower Urinary Tract Symptoms

Keywords

Lower urinary tract symptoms leading to lower flow rates

Outcome Measures

Primary Outcomes (1)

  • Mean Urine Flow Rate

    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.

    At every voiding event during approximately one week.

Study Arms (2)

Disposable device first, then Digital device

EXPERIMENTAL
Device: Disposable deviceDevice: Digital deviceDevice: Clinic flow measurement

Digital device first, then Disposable device

EXPERIMENTAL
Device: Disposable deviceDevice: Digital deviceDevice: Clinic flow measurement

Interventions

Disposable deviceDEVICE

Disposable urine flow meter

Digital device first, then Disposable deviceDisposable device first, then Digital device
Digital deviceDEVICE

Digital urine flowmeter

Digital device first, then Disposable deviceDisposable device first, then Digital device
Clinic flow measurementDEVICE

Clinic gold standard flow measurement

Digital device first, then Disposable deviceDisposable device first, then Digital device

Eligibility Criteria

Age45 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

David Geffen school of Medicine at UCLA, Department of Urology

Los Angeles, California, 90095-1738, United States

Location

UMC ST Radboud Nijmegen, Department of Urology

Nijmegen, 6500 HB, Netherlands

Location

Klinika Urology, Akademi Medycznej

Warsaw, 02005, Poland

Location

Clinical Research Unit, Morriston Hospital, Swansea NHS Trust

Swansea, SA6 6NL, United Kingdom

Location

MeSH Terms

Conditions

Urinary Bladder Neck ObstructionLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Head of Clinical Research Area Health Care
Organization
Astra Tech AB
+46317763000

Study Officials

  • Magnus Jacobsson, Prof.

    Dentsply Sirona Implants and Consumables

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2008

First Posted

July 4, 2008

Study Start

July 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 11, 2021

Results First Posted

June 23, 2011

Record last verified: 2021-11

Locations

NL(1)PL(1)GB(1)US(1)