Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparative Efficacy of DuodartTM Versus Watchful Waiting With Step-up Therapy to Tamsulosin in the Management of Treatment naïve Men With Symptomatic BPH
Brief Summary: Study FDC114615 is a two year, multi-centre, randomised, open-label trial to assess the efficacy of Dutasteride plus tamsulosin when compared to the standard practice of watchful waiting, with a defined escalation to tamsulosin in treatment naive men with symptomatic benign prostate hyperplasia (BPH).

Once consented, each subject will undergo screening procedures to ensure the prostate volume and post void residual are within eligible range. If all entry criteria are met, subjects will be randomised (1:1) to receive Dutasteride plus tamsulosin with lifestyle advice or watchful waiting, with lifestyle advice, with a defined escalation to tamsulosin. Escalation will be initiated when no improvement from baseline is scored using the International Prostate Symptom Score (version 2) (IPSS) questionnaire.

After randomisation, the subjects return to site at one month, then every 13 weeks until two years of treatment is complete or they are withdrawn. Key assessments, such as Adverse Events (AE's) and concomitant medication monitoring and completion of the quality of life questionnaires are performed at each visit and the data recorded.


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 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
D: 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

Answer: A