Self-Management for Men With Uncomplicated Lower Urinary Tract Symptoms
Recruitment status was Active, not recruiting
|First Received Date ICMJE||December 22, 2005|
|Last Updated Date||July 9, 2009|
|Start Date ICMJE||January 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||treatment failure (use of drug therapy for symptom control, surgical intervention, symptom deterioration of 3 points or more measured with the I-PSS, acute urinary retention, or death)|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00270309 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Self-Management for Men With Uncomplicated Lower Urinary Tract Symptoms|
|Official Title ICMJE||Self-Management for Men With Uncomplicated Lower Urinary Tract Symptoms. A Randomised Controlled Trial Against Standard Therapy|
Objective To test the hypothesis that a nurse-led self-management programme is effective for men with uncomplicated lower urinary tract symptoms. This will be achieved by comparing symptom seveirty and the amount of drug therapy used to manage these symptoms in men who attend a self-management programme, compared to those who do not.
Study design This study will use the format of a randomised controlled trial. 200 new patients with uncomplicated LUTS will be randomised to either attend or not attend (standard therapy) a self-management programme. The programme provides education, reassurance, prostate cancer risk, advice on lifestyle modifications (e.g. fluids - type and amount), concurrent medication re-scheduling and behavioural changes (double-voiding, strategies for dribbling, and bladder re-training). These strategies are learnt through group discussion, problem solving and goal setting.
All men start the study with a period of watchful waiting (monitoring symptoms only) and are followed up for a total of 1 year. At each assessment (baseline, 3, 6, and 12 months) symptom severity and the use of drug therapy to control symptoms will be compared between the two groups. The only difference between them is that one group has attended a self-management programme and the other has not.
Potential application of results Self-management focuses on patient involvement in health care by involving them in the day-to-day control of their symptoms. If effective, self-management may provide a long-term method of managing LUTS without using drug therapy, thereby offering considerable health gain and financial savings.
The NHS Modernisation Agency wishes to develop the role of the nurse specialist to manage some patients independently of doctors. Nurse-led LUTS assessment clinics are now well established, perhaps nurses managing these patients with self-management interventions may become part of standard therapy.
3. STATISTICAL ANALYSIS
3.1. The two groups will be directly compared with respect to all outcome measurements over each man's 12 month study period.
3.2. Analysis will be on an intention to treat basis, i.e. - men will always be analysed in the group to which they were assigned.
3.3. Statistical analysis will be performed with STATA Version 7. An unpaired t-test will be used to analyse continuous variables e.g. I-PSS, and chi-squared or exact tests will be used for categorical data. Logarithmic transformation will be used to normalise continuous variables.
3.4. Sample size - A minimum of 84 men are required in each group to have a 90% chance of detecting a 3 point difference in mean I-PSS score (SD=6) at the 5% level of significance using the unpaired t-test. We have chosen a 3-point reduction in I-PSS as it corresponds to a detectable clinical difference in symptoms by patients.
4. DATA COLLECTION
4.1. Each man is part of the study programme for 12 months. After this time each man is discharged from the study programme. If they still require the services of the urology out-patients for further appointments, investigations or treatment, this will be arranged.
4.2. If self-management is seen to be effective then it will be offered to men in Group 2 who received only standard treatment.
4.3. The information is anonymised with each patient being given a unique identification number.
4.4. Data will be stored securely on The Royal College of Surgeons network in accordance with the Data Protection Act 1988. Access to this data will be limited to the data manager and the study coordinator
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Uncomplicated Lower Urinary Tract Symptoms|
|Intervention ICMJE||Behavioral: Self-management|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Completion Date||May 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||40 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00270309|
|Other Study ID Numbers ICMJE||64582|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||The Royal College of Surgeons of England|
|Collaborators ICMJE||University College, London|
|Information Provided By||The Royal College of Surgeons of England|
|Verification Date||December 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP