Clinical study in prostate enlargement.

Phase 2

Not yet recruiting

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

• Registration Number: CTRI/2024/06/069480
• Lead Sponsor: Vasu Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male participants aged between 40 to 80 years diagnosed with symptomatic BPH and coexisting overactive bladder symptoms (OABS), with an IPSS greater than 8, who are treatment-naive and do not wish to undergo surgery;2.Symptomatic participants of BPH (determined by IPSS/focused urological exam/Investigations) associated with any one or more of the following overactive bladder symptoms like; micturition frequency of greater than 8 per 24 hrs, nocturia episodes of greater than 2 per 24 hrs., urgency episodes of greater than 1 per 24 hrs with or without urge incontinence;3.Participants should be willing and able to complete a 4-day voiding diary (before each visit i.e., on baseline, week 2, week 4, 8, 12 and 16) and questionnaires.

Exclusion Criteria

1.Age below 40 and above 80 years at the time of screening;

2.Participant not willing for consent for inclusion in the above study and those who cannot comply with the study protocol due to concomitant CVA, CRF, vesical stones, untreated UTI, diabetic neuropathy, uncontrolled hypertension (BP greater than 180/100), neurological disease etc.;

3.Participants of BPH with absolute indications for surgery;

4.Participants with contraindication, hypersensitivity and allergic reaction to components of investigational product and or tamsulosin hydrochloride;

5.Participants with prior history of prostatic/urethral surgery, acute or chronic prostatitis, known prostate cancer, suspected neurogenic bladder, urethral stricture and priapism;

6.Any other clinical condition which may jeopardize the study outcome or participant health in any way as per discretion of investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified