Condition category
Urological and Genital Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
09/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.erasmusmc.nl/urologie/furore

Contact information

Type

Scientific

Primary contact

Prof R. van Mastrigt

ORCID ID

Contact details

Head sector FURORE
Department of Urology
Room EE1630
Erasmus MC Rotterdam
PO Box 1738
Rotterdam
3000 DR
Netherlands
+31 10 4088058
r.vanmastrigt@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A300112

Study information

Scientific title

Acronym

Study hypothesis

With increasing age the prostate enlarges. In response to the increasing resistance to urinary flow, the urinary bladder changes (compensation). At a later stage the bladder may decompensate which eventually makes emptying the bladder impossible (urinary retention).

During the compensation phase, pressures in the bladder may become excessive, leading to reflux of urine and kidney damage. Compensation and decompensation of the urinary bladder muscle are important issues in the decision to operate. These changes in function of the bladder muscle can be assessed by calculating its contractility from urodynamic measurements of pressure and flow-rate during voiding. Presently, such pressure measurements are invasive.

For this reason these measurements are not done as often as desirable and have also rarely been done in an epidemiological study. Therefore no reference data on the development of the contractility of the bladder muscle in response to prostatic enlargement is available and it is unknown if and when a certain degree of obstruction of the outflow tract will cause irreversible damage to the bladder wall muscle.

The sector Furore (Physics, function and reconstruction of the urinary tract) of the department Urology of the EMCR has developed a method to measure the urinary bladder pressure non-invasively. This method now makes it possible to acquire the necessary reference data in a non-invasive epidemiological study.

Aim:
To investigate the consequences of prostate hyperplasia on the bladder in the course of time.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Longitudinal study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Benign Prostatic Hyperplasia (BPH)

Intervention

Non-invasive measurement of the urinary bladder pressure.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The study is observational, there is no endpoint.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/11/2001

Overall trial end date

01/10/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men aged 38 - 77 years
2. Mentally and physically able to complete a voiding diary and to visit the outpatient clinic
3. Written informed consent to participate in the trial

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

1020

Participant exclusion criteria

1. Unable to urinate in a standing position
2. Previous lower urinary tract surgery
3. Congenital disease of the lower urinary tract
4. Use of medication or other interventions for lower urinary tract symptoms
5. Other diseases that could alter urinary function (e.g., Parkinsons, Cerebrovascular Accident [CVA], Diabetes Mellitus [DM], kidney failure, bladder/prostate cancer, current urinary tract infection)
6. Heart failure
7. Voiding pattern at first visit incompatible with measurement technique, e.g., flow rate too low (less than 6 ml/s), interrupted voiding, straining
8. Mentally or physically unable to complete a voiding diary and to visit the outpatient clinic
9. Use anticoagulants

Recruitment start date

01/11/2001

Recruitment end date

01/10/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Head sector FURORE
Rotterdam
3000 DR
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

http://www.erasmusmc.nl/

Funders

Funder type

Charity

Funder name

Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands)

Alternative name(s)

Dutch Kidney Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Funder name

Erasmus University Rotterdam (The Netherlands) - Vereniging Trustfonds

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes