A controlled trial into the benefit of topical perianal glyceryl trinitrate (GTN) as a sphincter relaxant, pre-insertion of ultrasound probe for trans rectal ultrasound (TRUS) guided biopsy of the prostate. - GTN pre-TRUS biopsy
- Conditions
- Prostate Cancer Diagnosis – Pain relief during biopsy
- Registration Number
- EUCTR2004-002882-19-GB
- Lead Sponsor
- Mid Cheshire Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 300
Inclusion Criteria
Patients already listed for transrectal ultrasound guided biopsy of prostate to exclude or confirm prostate cancer histologically.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Cardiac disease. Hypotension. Already on nitrate therapy, sildenafil, tadalafil or vardenafil. Recent history of anaemia. Severe liver or kidney impairment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the benefit of perianal topical GTN ointment as an internal anal sphincter relaxant and hence analgesic, pre-insertion of a rectal ultrasound probe for transrectal ultrasound guided biopsy of prostate.;Secondary Objective: ;Primary end point(s): End of biopsy: Patient to be assessed by pain questionnaire
- Secondary Outcome Measures
Name Time Method