Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000548639
Ethics application status
Approved
Date submitted
14/09/2005
Date registered
29/09/2005
Date last updated
29/09/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Study into the effectiveness of nitrate patches in improving urine flow and decreasing voiding problems associated with prostate enlargement
Scientific title
THE EFFECT OF NITRATES ON PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA
Universal Trial Number (UTN)
Trial acronym
NO LUTS Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower urinary tract symptoms associated with benign prostatic hypertrophy 673 0
Condition category
Condition code
Other 747 747 0 0
Prostate

Intervention/exposure
Study type
Interventional
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 [1] 610 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 934 0
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 [1] 934 0
Secondary outcome [1] 1785 0
To see if there are significant improvements in peak urinary voiding flow rates as measured by uroflowmetry machine.
Timepoint [1] 1785 0

Eligibility
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
Sex
Males
Can healthy volunteers participate?
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
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?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 828 0
Charities/Societies/Foundations
Name [1] 828 0
Clifford Craig Medical Research Trust
Country [1] 828 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Clifford Craig Medical Research Trust
Address
Country
Australia
Secondary sponsor category [1] 696 0
Charities/Societies/Foundations
Name [1] 696 0
Clifford Craig Medical Research Trust
Address [1] 696 0
Country [1] 696 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2092 0
Launceston General Hospital
Ethics committee address [1] 2092 0
Ethics committee country [1] 2092 0
Australia
Date submitted for ethics approval [1] 2092 0
Approval date [1] 2092 0
Ethics approval number [1] 2092 0

Summary
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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35995 0
Address 35995 0
Country 35995 0
Phone 35995 0
Fax 35995 0
Email 35995 0
Contact person for public queries
Name 9799 0
Dr. Raymond S K Tong
Address 9799 0
Urology Registrar
Department of Surgery
Launceston General Hospital
Charles St
Launceston TAS 7250
Country 9799 0
Australia
Phone 9799 0
+61 3 63487111
Fax 9799 0
+61 3 63487594
Email 9799 0
[email protected]
Contact person for scientific queries
Name 727 0
Dr. Raymond S K Tong
Address 727 0
Urology Registrar
Department of Surgery
Launceston General Hospital
Charles St
Launceston TAS 7250
Country 727 0
Australia
Phone 727 0
+61 3 63487111
Fax 727 0
+61 3 63487594
Email 727 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.