Evaluate efficacy and safety of combination of Silodosin and Tadalafil vs. Silodosin or Tadalafil alone in patients with enlarged prostate
- Conditions
- Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
- Registration Number
- CTRI/2020/07/026440
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate improvement in IPSS score for lower urinary tract symptoms due to Benign Prostatic Hyperplasia.Timepoint: 4 weeks, 8 weeks, 12 weeks
- Secondary Outcome Measures
Name Time Method 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