A prospective, randomised, double-blind placebo-controlled trial of effects of glyceryl trinitrate ointment on the pain experiences during transdermal ultrasound guided biopsy of the prostate
| ISRCTN | ISRCTN66668243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66668243 |
| Protocol serial number | N0040122630 |
| Sponsor | Department of Health (UK) |
| Funder | Bedford Hospital NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 31/03/2020
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr R Calvert
Scientific
Scientific
Specialist Register in Urology
Bedford Hospital NHS Trust
South Wing
Kempston
Bedford
MK42 9DJ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A prospective, randomised, double-blind placebo-controlled trial of effects of glyceryl trinitrate ointment on the pain experiences during transdermal ultrasound guided biopsy of the prostate |
| Study objectives | To test the hypothesis: Topical 0.2% GTN ointment reduced the discomfort or pain experiences during transrectal ultrasound guided biopsy of the prostate. Results will be submitted for presentation to a national/international urology meeting. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Prostate biopsy |
| Intervention | Glyceryl trinitrate ointment vs placebo |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | After logistical considerations, we propose to aim for 50 patients in each group so that we might detect a difference in pain score 1/10 with a power of 90% and the aforementioned assumptions. It should be possible to complete this study in less than 6 months. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 01/09/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Bedford Hospital NHS Trust
Bedford
MK42 9DJ
United Kingdom
MK42 9DJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
31/03/2020: No publications found, all search options exhausted, study status unverified.
