Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
None listed
Sponsors
University College of Medical Sciences University of Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male Patients aged >40 and 2.Patients with clinical symptoms LUTS due to BPH without any absolute indication for surgery/TURP. 3.Patients with newly diagnosed symptomatic BPH not on prior alpha blocker/5 alpha reductase inhibitors /antichoneergic/ antimuscarinics/ B3agonists etc therapy any medication
Exclusion criteria
Exclusion criteria: 1.Patients with mental disorders or illness who cannot understand or comply with the study protocol. 2.BPH in patients with absolute indications for surgery/TURP (like CRF, hydronephrosis, untreated UTI, refractory acute urinary retention, recurrent hematuria due to BPH). 3.Patients with LUTS/BOO due to causes other than BPH eg vesical calculus, urethral stricture, carcinoma bladder. 4.Prior T/t with alpha blockers/5ï?¡ reductase inhibitors/anticholinergics/ï?¢ agonists) 5.Patients with known allergy/contraindications to tamsulosin therapy. 6.Patients with previous history of urological/prostate surgery/Cancer prostate. 7.Patients with comorbidity like Diabetic neuropathy , CVA, Neurological disease. 8.Patients undergoing cataract surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To analyse the efficacy of medical/tamsulosin therapy in patients of LUTS due to BPH according to the ultrasonographic grade of intravesical prostatic protrusion(IPP). Efficacy outcome will be assessed by noting change if any in the IPSS (Subjective), PVR and uroflow parameters (MFR,AVR-Objective)after eight weeks of Tamsulosin therapy. A cahnge in the MFR by 1 ml/sec and in IPSS by 3 will be construed to be significant.Timepoint: Eight Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To investigate whether the grade of IPP can predict bladder outlet obstruction(BOO) by determining the maximum flow rate (MFR) and post residual volume(PVR) at 0 weeks. 2.To document the safety of medical/Tamsulosin therapy by recording the frequency of treatment emergent clinical and lab adverse events(TEAE), if any. 3. Compliance to administered therapy will be assessed by asking patient to ring empty strips consumed in last 60 days at all visits.Timepoint: All visits with the final end point up to eight weeks. | — |
Countries
India
Contacts
Public ContactDr Drishti Batra
University College of Medical Sciences University of Delhi GTBH
Outcome results
None listed