A longitudinal non-invasive study of changes in urinary bladder contractility secondary to benign prostatic hyperplasia.

ISRCTN ISRCTN46624580
DOI https://doi.org/10.1186/ISRCTN46624580
Secondary identifying numbers A300112
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
10/06/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof R. van Mastrigt
Scientific

Head sector FURORE
Department of Urology
Room EE1630
Erasmus MC Rotterdam
PO Box 1738
Rotterdam
3000 DR
Netherlands

Phone +31 10 4088058
Email r.vanmastrigt@erasmusmc.nl

Study information

Study designLongitudinal study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Scientific titleA longitudinal non-invasive study of changes in urinary bladder contractility secondary to benign prostatic hyperplasia.
Study objectivesWith 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(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedBenign Prostatic Hyperplasia (BPH)
InterventionNon-invasive measurement of the urinary bladder pressure.
Intervention typeOther
Primary outcome measureThe study is observational, there is no endpoint.
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/11/2001
Completion date01/10/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants1020
Total final enrolment1020
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2001
Date of final enrolment01/10/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Head sector FURORE
Rotterdam
3000 DR
Netherlands

Sponsor information

Erasmus Medical Centre (Netherlands)
University/education

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Website http://www.erasmusmc.nl/
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Charity

Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Dutch Kidney Foundation
Location
Netherlands
Erasmus University Rotterdam (The Netherlands) - Vereniging Trustfonds

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/01/2014 10/06/2021 Yes No

Editorial Notes

10/06/2021: Publication reference and total final enrolment added.