Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Self-management for Men With Uncomplicated Lower Urinary Tract Symptoms. A Randomised Controlled Trial Against Standard Therapy
Brief Summary: 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.


Options:
A: Arm Label: Dutasteride plus tamsulosin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dutasteride plus tamsulosin | Arm Label: Watchful waiting with escalation to tamsulosin; Type: EXPERIMENTAL; Interventions: Drug: tamsulosin | Intervention Type: DRUG; Name: Dutasteride plus tamsulosin; Assigned to Arm(s): Dutasteride plus tamsulosin | Intervention Type: DRUG; Name: tamsulosin; Assigned to Arm(s): Watchful waiting with escalation to tamsulosin
B: Intervention Type: BEHAVIORAL; Name: Self-management; Assigned to Arm(s): N/A
C: Arm Label: Behavioral and Exercise Therapy (M-BET); Type: EXPERIMENTAL; Interventions: Behavioral: Behavioral, Drug: placebo | Arm Label: Drug Therapy w/ Behavioral Placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: tamsulosin (alpha-adrenergic antagonist medication), Behavioral: placebo | Arm Label: Combination Therapy; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Behavioral, Drug: tamsulosin (alpha-adrenergic antagonist medication) | Intervention Type: BEHAVIORAL; Name: Behavioral; Assigned to Arm(s): Behavioral and Exercise Therapy (M-BET), Combination Therapy | Intervention Type: DRUG; Name: tamsulosin (alpha-adrenergic antagonist medication); Assigned to Arm(s): Combination Therapy, Drug Therapy w/ Behavioral Placebo | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Behavioral and Exercise Therapy (M-BET) | Intervention Type: BEHAVIORAL; Name: placebo; Assigned to Arm(s): Drug Therapy w/ Behavioral Placebo
D: Arm Label: Behavioral Training; Type: EXPERIMENTAL; Interventions: Behavioral: Behavioral training | Arm Label: Drug Therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Oxybutynin chloride, extended-release | Intervention Type: BEHAVIORAL; Name: Behavioral training; Assigned to Arm(s): Behavioral Training | Intervention Type: DRUG; Name: Oxybutynin chloride, extended-release; Assigned to Arm(s): Drug Therapy

Answer: B