Evaluate efficacy and safety of combination of Silodosin and Tadalafil vs. Silodosin or Tadalafil alone in patients with enlarged prostate

Efficacy and safety of combination of Silodosin and Tadalafil vs. Silodosin or Tadalafil alone in patients with Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH): An open label randomized control trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026440

Enrollment

450

Registered

2020-07-08

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: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Interventions

Intervention1: Combination of Tablet Silodosin and Tablet Tadalafil: Combination of tab Silodosin 8mg and Tab Tadalafil 5mg once daily orally at bedtime for 12 weeks Control Intervention1: Tablet Silo

Eligibility

Inclusion criteria

Inclusion criteria: An International Prostatic Symptom Score (IPSS) of more than 7, Maximum Urinary Flow Rate (Qmax) less than 15 ml/second with minimum voided volume of more than 150 ml at screening, Willing and able to give written informed consent and comply with study procedures, Patients agreed not to use BPH medications during the research other than the study medications.

Exclusion criteria

Exclusion criteria: Known allergy or contraindications to Silodosin and Tadalafil and use of finasteride or dutasteride, History of syncope, and orthostatic hypotension, Bladder outlet obstruction due to cancer, calculi or stricture, Previous Transurethral Resection of the Prostate (TURP), Any neurological disorders affecting storage and voiding functions, Prostatitis, PSA greater than 4 ng/ml, An episode of acute urinary retention within 4 weeks of study initiation, Documented urinary tract infection, Poorly controlled diabetes mellitus, Poorly controlled hypertension.

Design outcomes

Primary

Measure	Time frame
To estimate improvement in IPSS score for lower urinary tract symptoms due to Benign Prostatic Hyperplasia.Timepoint: 4 weeks, 8 weeks, 12 weeks	—

Secondary

Measure	Time frame
To estimate improvement in IPSS QoL INDEX, improvement in Qmax, improvement in PVR, improvement in erectile function [EF] domain scores from IIEF 5 efficacy end points, and to determine safety assessment of Silodosin and Tadalafil including patientâ??s reporting of adverse event.Timepoint: 4 weeks, 8 weeks, 12 weeks	—

Countries

India

Contacts

Public ContactDr Rudra Prasad Ghorai

AIIMS RISHIKESH

kjmammen@gmail.com9814034185

Outcome results

None listed

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