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Efficacy of a single drug versus a combination of drugs for treatment of Prostate enlargement

Efficacy and Effectiveness of Tamsulosin alone vs Tadalafil alone vs combination of Tamsulosin and Tadalafil in the treatment of Lower Urinary tract symptoms (LUTS) secondary to Benign Prostatic Hyperplasia (BPH): A Randomized double-blind trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031321
Enrollment
190
Registered
2021-02-16
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

Control Intervention1: Tablet Tamsulosin : 0.4 mg Once at night Duration of 3 months Control Intervention2: Tablet Tadalafil: 5mg Once at night Duration of 3 months Control Intervention3: Combination

Sponsors

Dr Shruti Pandit
Lead Sponsor
Dr Arun Chawla
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Men over the age of 45 years who are sexually active with significant LUTS secondary to BPH. IPSS score >8 Maximum urinary flow rate(Qmax) â?? 5-15 ng/ml Patients willing to give consent and comply with the study procedures.

Exclusion criteria

Exclusion criteria: Patients with contraindications to the drugs under study, including patients with known allergy to the medications, patients with cardiac disease on nitrates. Patients presenting with acute urinary retention. Patients with previous history of TURP, VIU. Previous history of use of medications for BPH Patients not willing to give consent to participate in the study. Patients with a post-void residue > 100ml.

Design outcomes

Primary

MeasureTime frame
To measure the efficacy of the three treatment groups in terms of improvement in the following scores: IPSS VPSS M-VPSS IIEF5 IPSS-QOL MSHQ-EjD SF Timepoint: 1 month 2 months 3 months—

Secondary

MeasureTime frame
To assess the difference in efficacy by assessing the response in each subset of the above-mentioned scores. Assessing the Neutrophil-lymphocyte ratio and platelet-lymphocyte ratio in predicting the response or failure of medical management. Timepoint: 3 months—

Countries

India

Contacts

Public ContactDr Shruti Pandit

Kasturba Medical Hospital, Manipal

urologyarun@yahoo.com9008002440

Outcome results

None listed

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