Not Yet RecruitingPhase 1ACTRN12605000548639

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

THE EFFECT OF NITRATES ON PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA


Sponsor

Clifford Craig Medical Research Trust

Enrollment

75 participants

Start Date

Oct 1, 2005

Study Type

Interventional

Conditions

Summary

You are invited to participate in a study to assess the effectiveness of nitrate patches in decreasing voiding problems and improving urine flow in men who have prostate enlargement. By being involved in this study you will play a very important role in the development of alternative medical treatments for this very common male problem. It will allow better and cheaper ways to relieve the symptoms without the need for surgery. The prostate is a chestnut size gland that lies under the bladder. The tube that urine flows through (the urethra) passes through the prostate. Not uncommonly, the urethra is blocked in older males due to prostate enlargement. This results in troubling voiding symptoms known as lower urinary tract symptoms. These include: - Slowness initiating urine flow. - Poor urine stream. - Straining to urinate. - Dribbling urine especially at the end of voiding. - Feeling the bladder is not completely empty after voiding. - Getting frequent and sudden urges to urinate but only passing small amounts. - Waking up many times at night to pass urine. The enlarged prostate has a muscular component, which contributes to the blockage of urine flow especially when this muscle is tense.


Eligibility

Sex: MalesMin Age: 18 Yearss

Inclusion Criteria1

  • 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 Criteria1

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Prospective randomised placebo controlled double blinded trial involving three arms: Placebo group, 25mg GTN patch group and 50mg GTN patch group. Patches are to be applied to an area of clean hair

Prospective randomised placebo controlled double blinded trial involving three arms: Placebo group, 25mg GTN patch group and 50mg GTN patch group. Patches are to be applied to an area of clean hairless skin from 0800 to 2200 daily during the six week trial.


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12605000548639