Comparison of Silodosin & tamsulosin in management of prostate enlargement

Not Applicable

• Conditions: Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

• Registration Number: CTRI/2019/11/021996
• Lead Sponsor: niversity College of Medical Sciences University of Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br/ ><br> <br/ ><br>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.