Plain English Summary
Not provided at time of registration
Trial website
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
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