Self-management for Men With Uncomplicated Lower Urinary Tract Symptoms
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|ClinicalTrials.gov Identifier: NCT00270309|
Recruitment Status : Completed
First Posted : December 26, 2005
Last Update Posted : May 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Uncomplicated Lower Urinary Tract Symptoms||Behavioral: Self-management||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Self-management for Men With Uncomplicated Lower Urinary Tract Symptoms. A Randomised Controlled Trial Against Standard Therapy|
|Study Start Date :||January 2004|
|Primary Completion Date :||April 2004|
|Study Completion Date :||October 2006|
- 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)
- quality of life / bother assessment (BPH Impact Index)
- Short Form-36
- Illness Perception Questionnaire - IPQ
- health-seeking behaviour (unscheduled clinic, A&E or GP visits)
- 3 day frequency / volume chart
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270309
|Principal Investigator:||Christian Brown||Clinical Effectiveness Unit, The Royal College of Surgeons of England|
|Study Chair:||Mark Emberton||Clinical Effectiveness Unit, The Royal College of Surgeons of England|
|Study Director:||Jan HP Van der Meulen, PhD||Clinical Effectiveness Unit, The Royal College of Surgeons of England|