The India Prostatic Tissue Lift Extend Observation Study: Prospective, observational, multicentre study to evaluate the outcomes in patients undergoing UroLift for lower urinary tract symptoms in India
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Teleflex Medical India Private Limited
- Enrollment
- 145
- Locations
- 9
- Primary Endpoint
- Mean change in IPSS score at 3 months from the baseline
Overview
Brief Summary
This is a non-interventional, prospective, observational, multicentre study to evaluate the outcomes in patients undergoing UroLift procedure for lower urinary tract symptoms in India. The study aims to gain insights into outcomes of UroLift in clinical settings in India for treatment of patients with urinary outflow obstruction secondary to benign prostatic hyperplasia. The study also aims to enhance awareness about minimally invasive techniques like UroLift and address concerns surrounding BPH treatment’s impact on sexual function. The patients will be followed up for a period of 3 months. The primary objective is to estimate the mean change in International Prostate Symptom Score (IPSS) at 3 months from the baseline.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 50.00 Year(s) to 99.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •1 Patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and undergoing UroLift procedure as determined by their urologist.
- •2 Males with age ≥ 50 years 3 International Prostate Symptom Score (IPSS) ≥ 13 4 Prostate volume ≤ 100 cc per imaging 5 Patients/LAR willing to sign written Informed Consent Form.
Exclusion Criteria
- •1 Active urinary tract infection at time of treatment 2 Unable or unwilling to complete all required questionnaires and follow up assessments 3 Unable or unwilling to sign informed consent form.
Outcomes
Primary Outcomes
Mean change in IPSS score at 3 months from the baseline
Time Frame: 3 month
Secondary Outcomes
- 1 Mean percentage change in IPSS score at 3 months from the baseline(2 Mean change in quality-of-life (QoL) due to urinary symptoms as measured by IPSS at 3 months from the baseline)
Investigators
Dr Rohit Joshi
Aarna Super Speciality Hospital