Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male patients aged more than 50 years. 2. Clinically and radiologically confirmed BPH. 3. Patients who have shown improvement in LUTS after 4 weeks of daily tamsulosin therapy. 4. Patients willing to participate and giving written informed consent
Exclusion criteria
Exclusion criteria: 1. History or evidence of carcinoma prostate. 2. Prior prostate or urethral surgery. 3. Urethral stricture, neurogenic bladder, or active urinary tract infection. 4. Patients on concomitant medications such as 5 alpha reductase inhibitors, anticholinergics, or phosphodiesterase-5 inhibitors. 5. Severe systemic illness (example-hepatic, renal, or cardiac failure). 6. Known hypersensitivity to tamsulosin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax) from baseline after randomizationTimepoint: 1, 3, and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in post-void residual urine volume (PVR)Timepoint: 1, 3, and 6 months.;Incidence of adverse effects (dizziness, postural hypotension, fatigue, ejaculatory dysfunction) during follow-up.Timepoint: 1, 3, and 6 months.;Patient satisfaction/compliance during follow-up.Timepoint: 1, 3, and 6 months.;Recurrence or worsening of LUTS assessed by IPSS score.Timepoint: 1, 3, and 6 months. | — |
Countries
India
Contacts
AIIMS Jodhpur