A study to find out the medication which offers maximum health benefits with minimum spending by the patient among the three commonly used medications in the treatment of benign prostatic hyperplasia, a disease in aging men which results in bothersome urinary problems.

An analysis of the Cost-effectiveness of alfuzosin, tamsulosin and silodosin in benign prostatic hyperplasia.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/10/004112

Enrollment

Registered

2013-10-29

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: null- Patients of benign prostatic hyperplasia between the age of 45 to 90 years who are otherwise maintaining a good general health.

Interventions

Intervention1: Silodosin: Oral, 8mg OD for 3 months. Control Intervention1: Alfuzosin: Oral, 10mg OD for 3 months Control Intervention2: Tamsulosin: Oral, 0.4mg OD for 3 months.

Eligibility

Inclusion criteria

Inclusion criteria: •Male subjects >= 45 years with BPH and associated lower urinary tract symptoms (LUTS). •International prostate symptom score (IPSS) >= 8 •Quality of life score (QLS) >= 3 •Maximum flow rate (Qmax) 4ml/s with a voided volume of >100 ml •Willingness to give written informed consent and to comply with the study procedure, and available for regular follow up.

Exclusion criteria

Exclusion criteria: •Patients already on 5 Î± reductase inhibitors •Severe hepatic or renal insufficiency •Patients concomitantly receiving strong CYP3A4 inhibitors •Urinary tract infections •Urethral stricture •Neurogenic bladder •PSA >= 5ng/ml •History of urethral or prostatic operation •Likely to need catheterization within next 3 months •Hypotension or severe untreated hypertension •History of oesophageal or intestinal obstruction •Patients receiving the drugs that may interfere with the response to study medications, within previous 6 months like verapamil, androgens, anti androgens, diuretics, cholinergics, anticholinergics, phytotherapy •History of alcohol or drug abuse •Currently suffering from serious disease or malignancy •Significant psychiatric problems •Patients at increased risk of QTc prolongation

Design outcomes

Primary

Measure	Time frame
Treatment success is defined as 30 percent or more improvement in International Prostate Symptom Score (IPSS) from baseline and its maintenance over the study periodTimepoint: Baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.	—

Secondary

Measure	Time frame
Not applicableTimepoint: Not applicable	—

Countries

India

Contacts

Public ContactDr H P Pundarikaksha

Kempegowda Institute Of Medical Sciences.

drpundarikahp@gmail.com9880052054

Outcome results

None listed

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