FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002882-19-GB
Enrollment
300
Registered
2005-02-17
Start date
2004-12-10
Completion date
Unknown
Last updated
2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer Diagnosis – Pain relief during biopsy

Interventions

Trade Name: Rectogesic Product Name: Glyceryl trinitrate ointment 0.4% Pharmaceutical Form: Ointment

Sponsors

Mid Cheshire Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

Exclusion criteria: Cardiac disease. Hypotension. Already on nitrate therapy, sildenafil, tadalafil or vardenafil. Recent history of anaemia. Severe liver or kidney impairment.

Design outcomes

Primary

MeasureTime frame
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—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026