ltrasonographic Grade of Prostate Protrusion as guide to treatment of prostate enlargement

Not Applicable

Conditions: Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Registration Number: CTRI/2018/12/016556

Lead Sponsor: niversity College of Medical Sciences University of Delhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male Patients aged >40 and <80 years giving informed consent to participate in the study.

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

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br/ ><br>2.To document the safety of medical/Tamsulosin therapy by recording the frequency of treatment emergent clinical and lab adverse events(TEAE), if any. <br/ ><br>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.