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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 000726
ACTR Number: ACTRN12605000548639
Trial Status: Registered
Date Submitted: 14/09/2005
Date Registered: 29/09/2005

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Public title: Study into the effectiveness of nitrate patches in improving urine flow and decreasing voiding problems associated with prostate enlargement
ANZCTR registration title: THE EFFECT OF NITRATES ON PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA
Secondary ID: 
UTN:
Trial acronym: NO LUTS Trial

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Health condition(s) or problem(s) studied:
Lower urinary tract symptoms associated with benign prostatic hypertrophy 
Condition category: Condition code:
Other Prostate 

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Description of intervention(s) / exposure: 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.
Intervention code:Treatment: drugs 
Comparator / control treatment: Placebo
Control group: Placebo

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Primary outcome:The primary end point of this study is to see if nitrates in the form of a glyceryl trinitrate (GTN) patch will improve lower urinary tract symptoms associated with benign prostatic hyperplasia (enlarge prostate). Lower urinary tract symptoms are associated with bladder urine flow obstruction. These symptoms include: slowness to initiate urine flow, poor stream, straining to urinate, dribbling of urine and the feeling of incomplete bladder emptying. 
Timepoint: 
Secondary outcome:To see if there are significant improvements in peak urinary voiding flow rates as measured by uroflowmetry machine. 
Timepoint: 

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Key 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).
Minimum Age: 18 Years
Maximum Age: Not stated
Gender: Males
Healthy volunteers? No
Key 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.

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Type of intervention for each patient is coded and master list is kept by pharmacy department until trial is over and evaluation begins
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): Computer generated randomisation so that each patient will have a one in three chance of being allocated to one of the trial arms
Masking / blinding: Blinded (masking used)
Who is/are masked/blinded:
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Safety/efficacy

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Phase Phase 1
Anticipated or actual date of first participant enrolement: 1/10/2005
Target sample size: 75
Recruitment status: Not yet recruiting

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Funding source:Charities/Societies/Foundations 
Name:Clifford Craig Medical Research Trust 
Address: 
Country:Australia 
Primary sponsor: Charities/Societies/Foundations
Name: Clifford Craig Medical Research Trust
Address:
Country: Australia
Secondary sponsor:Charities/Societies/Foundations 
Name:Clifford Craig Medical Research Trust 
Address: 
Country:Australia 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:Launceston General Hospital 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Countries of recruitment:Australia 
Brief 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.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Dr. Raymond S K Tong
Address: Urology Registrar Department of Surgery Launceston General Hospital Charles St Launceston TAS 7250
Country: Australia
Tel: +61 3 63487111
Fax: +61 3 63487594
Email: raysktong@yahoo.com.au

Contact person for scientific queries
Name: Dr. Raymond S K Tong
Address: Urology Registrar Department of Surgery Launceston General Hospital Charles St Launceston TAS 7250
Country: Australia
Tel: +61 3 63487111
Fax: +61 3 63487594
Email: raysktong@yahoo.com.au

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