A study to assess whether a combination of Tadalafil with Tamsulosin is equivalent to Tamsulosin or Tadalafil alone in the treatment of male lower urinary tract symptoms
- Conditions
- Health Condition 1: null- bph
- Registration Number
- CTRI/2017/09/009822
- Lead Sponsor
- na
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 159
1. An International Prostatic Symptom Score (IPSS) of >8,
2. maximum urinary flow rate (Qmax) >15 mL/second with minimum voided volume of
>125 mL at screening, and
3. willing and able to give written informed consent and comply with study procedures
4. PSA less than 4 ng/ml
1. contraindications to investigational drugs including patients with known allergies/allergy
to drugs under study,
2. history of syncope, and orthostatic hypotension
3. bladder outlet obstruction due to cancer, calculi or stricture,
4. previous transurethral resection of the prostate,
5. any neurological disorders affecting storage and voiding functions
6. an episode of acute urinary retention within 4 weeks of study initiation,
7. poorly controlled diabetes mellitus
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method At 1 MONTH AND 3 months of the treatment <br/ ><br> <br/ ><br>Primary efficacy end points will include - subjective (IPSS, IPSS QoL index) and objective <br/ ><br> <br/ ><br>(Qmax and PVR) changes from baseline. <br/ ><br> <br/ ><br>Safety assessment will include laboratory tests (hematology, clinical biochemistry, and <br/ ><br> <br/ ><br>urinalysis) and patientâ??s reporting of adverse event.Timepoint: At 1 MONTH AND 3 months of the treatment
- Secondary Outcome Measures
Name Time Method correlate improvement in ipss scotre with clinical improvementTimepoint: At 1 MONTH AND 3 months of the treatment