Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Sponsors
Teleflex Medical India Private Limited
Eligibility
Inclusion criteria
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 5 Patients/LAR willing to sign written Informed Consent Form
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in IPSS score at 3 months from the baselineTimepoint: 3 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 3 Mean change in sexual function scores related to erectile dysfunction and ejaculation dysfunction as measured by the 5- item version of the International Index of Erectile Function (IIEF-5) and Male Sexual Health Questionnaire Short Form (MSHQ-EjD-SF) questionnaires at 3 months from the baseline 4 Percentage of patients experiencing de novo sustained erectile dysfunction during 3-month follow-up period from the baseline 5 Percentage of patients experiencing retrograde ejaculation during 3-month follow-up period from the baseline 6 Percentage and counts of patients who experienced an adverse event and serious adverse event associated with the UroLift procedure within a 3-month follow-up period from the baselineTimepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Vivek Vijayendra
Teleflex Medical India Pvt Limited
Outcome results
None listed