Efficacy of a single drug versus a combination of drugs for treatment of Prostate enlargement
Not Applicable
- Conditions
- Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
- Registration Number
- CTRI/2021/02/031321
- Lead Sponsor
- Dr Shruti Pandit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To measure the efficacy of the three treatment groups in terms of improvement in the following scores: <br/ ><br>IPSS <br/ ><br>VPSS <br/ ><br>M-VPSS <br/ ><br>IIEF5 <br/ ><br>IPSS-QOL <br/ ><br>MSHQ-EjD SF <br/ ><br>Timepoint: 1 month <br/ ><br>2 months <br/ ><br>3 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess the difference in efficacy by assessing the response in each subset of the above-mentioned scores. <br/ ><br>Assessing the Neutrophil-lymphocyte ratio and platelet-lymphocyte ratio in predicting the response or failure of medical management. <br/ ><br>Timepoint: 3 months