Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS) caused by BPH. Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptoms (LUTS) Urinary Obstruction Voiding Time Uroflowmetry Urinary Flow Rate Prostate Urinary Retention Urinary Tract Diseases Prostate Diseases Urinary Tract Obstruction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult males aged 45 years or older. 2. Diagnosis of Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH). 3. Informed consent given by the patient to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients unable to comprehend the study or comply with it 2. Patients with LUTS due to conditions other than BPH Patients with a history of concomitant drug treatment with Androgens, 3. Anti-androgens, Diuretics, Cholinergics, or Anti-cholinergics within the past 3 months 4. Patients with evidence of symptomatic Urinary Tract Infections, Chronic inflammation, or severe Renal Impairment (Serum Creatinine more than 2.0 mg/dl). 5. Patients with concurrent Prostate Malignancy or a history of cancer within the preceding 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of Voiding Time (VT) Baseline (Enrollment Visit), Follow-Up Visit 1 (Day 7), Follow-Up Visit 2 (Day 14) Seconds | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of Voiding Time in patients with different levels of LUTS severity Baseline (Enrollment Visit), Follow-Up Visit 1 (Day 7), Follow-Up Visit 2 (Day 14) Seconds,Sensitivity, specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), and diagnostic accuracy of Voiding Time Baseline (Enrollment Visit), Follow-Up Visit 1 (Day 7), Follow-Up Visit 2 (Day 14) N/A | — |
Countries
India
Contacts
UCMS and GTB Hospital, Delhi