Study of topical glyceryl trinitrate and tolerance of transrectal ultrasound-guided prostate biopsy (TRUS biopsy).
| ISRCTN | ISRCTN49593371 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49593371 |
| Secondary identifying numbers | N0176127662 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 01/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Simon F Brewster
Scientific
Scientific
Department of Urology
Churchill Hospital
Churchill Drive
Headington
Oxford
OX3 7LJ
United Kingdom
| Phone | +44 (0)1865 225717 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | TRUS biopsy is the technique of choice for the diagnosis of carcinoma of the prostate (CaP), particularly for early stage tumours. The number of procedures is likely to escalate in the future. The procedure is performed in an outpatient setting without sedation, and without topical analgesia. However, many patients regard the uncomfortable nature of anal distension on the introduction of the rectal ultrasound probe as the most distressing feature of the procedure, and we hope that this can be alleviated with topical GTN (topical glyceryl trinitrate) paste. Patients will either complete the study by undergoing biopsy with GTN or control paste or withdraw and require inhaled nitrous oxide/general anaesthetic. We hope to recruit 100 patients. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Prostate |
| Intervention | Glyceryl trinitrate (GTN) or control paste |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | topical glyceryl trinitrate |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/2003 |
| Completion date | 01/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 100 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 01/05/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Urology
Oxford
OX3 7LJ
United Kingdom
OX3 7LJ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Oxford Radcliffe Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2005 | Yes | No |
