Study into the effectiveness of nitrate patches in improving urine flow and decreasing voiding problems associated with prostate enlargement

Phase 1

• Conditions: ower urinary tract symptoms associated with benign prostatic hypertrophy; Lower urinary tract symptoms associated with benign prostatic hypertrophy; Other - Prostate

• Registration Number: ACTRN12605000548639
• Lead Sponsor: Clifford Craig Medical Research Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 75

Inclusion Criteria

Pilot study of 75 patients with obstructive lower urinary tract symptoms associated with prostatomegaly (enlargement of the prostate) Patient selection criteria: Clinically significant lower urinary tract symptoms associated with prostatomegaly as accessed by a member of the urology medical team: - Slowness in initiating urine flow (hesistancy) - Poor urine stream - Straining to void - Dribbling urine especially at the end of the stream - Strong urges to urinate (urgency) - Frequent passage of small amounts of urine (frequency) - Frequent waking up at night to urinate (nocturia) - Incomplete bladder emptyingEvidence of enlargement of prostate at rectal examination (involves inserting a finger in the bottom to feel the prostate).

Exclusion Criteria

1. Previous prostatic surgery 2. Evidence of or suspicion of prostate cancer to rectal examination. 3. On alpha blockers during the last month (medication which also act on smooth muscle around the prostate to improve urine flow). 4. On 5 alpha reductase inhibitors (medication which is use to decrease the size of prostate over time). 5. Neurological conditions associated with unstable bladder (bladder spasms) and bladder hypocontraction (bladder which does not contract to empty urine). 6. Low blood pressure 7. Hypertrophic obstructive cardiomyopathy (uncommon heart condition which may be worsen with nitrates). 8. Already on nitrates medication 9. Taking phosphodiesterase inhibitors, Monoamine oxidase inhibitors, Tricyclic antidepressants (medications that interact with nitrates) 10. Cerebral haemorrhage 11. Allergic reaction to nitrates 12. Patients not cognitively able to understand study and questions involved.

Study & Design

• Study Type: Interventional
• Study Design: Not specified