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 |
| Protocol serial number | A300112 |
| Sponsor | Erasmus Medical Centre (Netherlands) |
| Funders | Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands), Erasmus University Rotterdam (The Netherlands) - Vereniging Trustfonds |
- 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
Contact information
Prof R. van Mastrigt
Scientific
Scientific
Head sector FURORE
Department of Urology
Room EE1630
Erasmus MC Rotterdam
PO Box 1738
Rotterdam
3000 DR
Netherlands
| Phone | +31 10 4088058 |
|---|---|
| r.vanmastrigt@erasmusmc.nl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Longitudinal study |
| Secondary study design | Cohort study |
| Scientific title | A longitudinal non-invasive study of changes in urinary bladder contractility secondary to benign prostatic hyperplasia. |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Benign Prostatic Hyperplasia (BPH) |
| Intervention | Non-invasive measurement of the urinary bladder pressure. |
| Intervention type | Other |
| Primary outcome measure(s) |
The study is observational, there is no endpoint. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 1020 |
| Total final enrolment | 1020 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2001 |
| Date of final enrolment | 01/10/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Head sector FURORE
Rotterdam
3000 DR
Netherlands
3000 DR
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/06/2021: Publication reference and total final enrolment added.
