Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: Silodosin (S)Test: One Tablet Silodosin 8mgs once a day at bed time after meals with sips of water.
Control Intervention1: Tamsulosin (T): One Tablet or capsule Tamsulosin Hydrochloride
Sponsors
University College of Medical Sciences University of Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1.All patients aged 45-80 years giving informed consent to participate in the study. 2.Patients with LUTS/ IPSS >8 due to BPH without any absolute indication for surgery. 3.Patients with enlarged prostate gland less than or equal to 30gm on either clinical examination or ultrasound assessment. 4.Patients with previously diagnosed BPH not on any medical therapy (patients on alpha blockers will be given 2-week drug washout prior to enrollment).
Exclusion criteria
Exclusion criteria: 1.Patients with mental disorders or illness who cannot understand or comply with the study protocol. 2. BPH with complications like CRF, hydronephrosis, acute bacterial prostatitis, hematuria. 3.Patients with LUTS and or bladder outlet obstruction due to causes other than BPH. 4.Patients with known drug allergy/ contraindications to tamsulosin & or silodosin. 5.Patients taking nitrates for CYP3A4 inhibitors (ketoconazole, ritonavir) and CYP3A4 inducers (rifampicin). Patients with previous history of prostate surgery, diagnosed cancer prostate. 6. Patients on 5 alpha reductase inhibitor therapy. 7.Patients with severe cardiac, hepatic or renal insufficiency. 8.Patients with active untreated UTI, urolithiasis, PVR >200mls, patients in whom cystoscopy or biopsy has been done from urinary tract in the past 2 weeks urethral stricture disease, neurogenic bladder, prostate or urethral surgery, any previous history of continuous intermittent catheterization, h/o postural hypotension, patients with uncontrolled severe hypertension. H/O treatment with verapamil, androgens, anti androgens, diuretics, cholinergics, anticholinergics, phytotherapy in the past 3 months, h/o alcohol abuse,malignancy. 9.Patients with h/o any conditions exposing them to increased risk of adverse effects of silodosin including any serious life threatening cardiovascular, renal, neurological, hepatic. 10. Any other disease or condition and any other systemic illness or disorder which in the clinical judgement of the investigator is/are deemed risky.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of IPSS, QOL Index scores objectively by uroflow parameters (PFR) and post void residual volume (PVR) at end of 8 weeksTimepoint: Improvement of IPSS, QOL Index scores and objectively by uroflow parameters (PFR) at and post void residual volume (PVR) in 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To document the safety of Silodosin and Tamsulosin therapy by recording the frequency of treatment emergent adverse events(TEAE)in the chosen clinical and lab parameters, if any. 2. Compliance to administered therapy will be assessed by asking patient to ring empty strips consumed in last 60 days at all visits. Assessment of derangement in any of our laboratory reports and via history and clinical examinationTimepoint: All visits with the final end point up to eight weeks. | — |
Countries
India
Contacts
Public ContactDr Prashali Chauhan
University College of Medical Sciences University of Delhi GTBH
Outcome results
None listed