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
Secondary identifying numbers N0040122630
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

Specialist Register in Urology
Bedford Hospital NHS Trust
South Wing
Kempston
Bedford
MK42 9DJ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA 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 objectivesTo 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) studiedUrological and Genital Diseases: Prostate biopsy
InterventionGlyceryl trinitrate ointment vs placebo
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/03/2003
Completion date01/09/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants100
Key inclusion criteriaAfter 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 criteriaNot provided at time of registration
Date of first enrolment01/03/2003
Date of final enrolment01/09/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Bedford Hospital NHS Trust
Bedford
MK42 9DJ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Bedford Hospital NHS Trust (UK)

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

Editorial Notes

31/03/2020: No publications found, all search options exhausted, study status unverified.