A study to assess whether a combination of tadalafil with tamsulosin is better than tamsulosin alone in the treatment of male lower urinary tract symptoms

A randomised, double blinder study comparing tamsulosin and placebo versus tamsulosin and tadalafil in male lower urinary tract symptoms - TAMTADA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/09/006226

Enrollment

120

Registered

2015-09-30

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- Male lower urinary tract symptoms

Interventions

Intervention1: Tamsulosin 0.4 mg per oral once a day and Tadalafil 5mg per oral once a day: One arm of the study will receive Tamsulosin and placebo while the other arm of the study will receive Tamsu

Eligibility

Inclusion criteria

Inclusion criteria: 1) Men more than 45 years with LUTS 2) International Prostate Symptom Score (IPSS) between 8 to 19 (moderate symptoms) 3) IPSS quality of life score 4 or more (bothersome LUTS) 4) Qmax (peak flow rate) between 5 and 15 ml/second 5) Willing to consent and take medications for the study duration

Exclusion criteria

Exclusion criteria: 1) Carcinoma prostate 2) LUTS due to other causes such as stricture urethra 3) Absolute indications for surgery - hematuria, recurrent urinary tract infection, bladder calculus, renal dysfunction and acute urinary retention 4) IPSS >19 (severe symptoms) 5) Post void residual urine >300ml 6) Already on 5 alpha reductase inhibitors treatment 7) On nitrate drugs 8) Other comorbid illness/cardiac condition contraindicating use of phosphodiesterase inhibitors 9) Unwilling to consent or take medications for the study period

Design outcomes

Primary

Measure	Time frame
International Prostate Symptom Score (IPSS)Timepoint: International Prostate Symptom Score (IPSS) will be assessed at baseline (zero months) and at three months of follow up	—

Secondary

Measure	Time frame
1)IPSS Qol (Quality of life score) 2)International Index of Erectile Function (IIEF score) 3) Qmax (Peak flow rate) 4) Post voidal residual urine (PVRU)Timepoint: At recruitment and at three months of follow up	—

Countries

India

Contacts

Public ContactSanthosh Nagasubramanian

Department of Urology, Christian Medical College, Vellore

nitinkekre@hotmail.com0432-2282111

Outcome results

None listed

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