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COMPARISION OF EFFICACY OF SILODOSIN VERSUS TADALAFIL IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ( LIKE FREQUENCY, URGENCY, URGE INCONTINENCE, NOCTURIA, POOR STREAM OF URINE, STRAINING TO VOID,ETC ) ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA ( A NON MALIGNANT ENLARGEMENT OF PROSTATE GLAND )

COMPARISION OF SILODOSIN VERSUS TADALAFIL IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA - STIPSS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/05/019342
Enrollment
136
Registered
2019-05-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N398- Other specified disorders of urinary system

Interventions

Control Intervention1: Silodosin: Patients receiving silodosin 8 mg per day orally at night for 4 weeks as decided by the Urologist Control Intervention2: Tadalafil: Patients receiving tadalafil 5 mg

Sponsors

Dr Mapranathukaran Devassy Robin
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Men aged more than 45 years with diagnosis of BPH with LUTS based on history, clinical examination with digital rectal examination and ultrasound Kidney , Ureter and Bladder(KUB) with post void residual volume 2 Baseline (week 0) conditions satisfying the following a Total international prostate symptom score(IPSS) more than or equal to 13 b IPSS quality of life (QoL) Index score more than or equal to 3 c Post void residual urine volume less than 100ml d Maximum urine flow rate less than 15ml/sec

Exclusion criteria

Exclusion criteria: 1 Suspected or diagnosed prostate cancer 2 Acute urinary tract infections 3 Neurogenic Bladder 4 Use of silodosin or tadalafil within 12 weeks prior to treatment 5 Use of anti-androgen or 5-α reductase inhibitor within 24 weeks prior to enrolment 6 Severe cardiovascular , hepatic and/or renal disorders 7 Cataract surgery planned during study period 8 Acute bacterial prostatitis 9 Postural hypotension 10 Previous prostate surgeries 11 Prior history of myocardial infarction or cerebrovascular accidents

Design outcomes

Primary

MeasureTime frame
To compare the efficacy between silodosin and tadalafil in patients with LUTS associated with BPHTimepoint: 4 weeks—

Secondary

MeasureTime frame
To compare the adverse effect profile between silodosin and tadalafilTimepoint: 4 weeks—

Countries

India

Contacts

Public ContactMapranathukaran Devassy Robin

Father Muller Medical College

drvijayalaxmimk@gmail.com9845237418

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026