| CTRI Number |
CTRI/2024/07/070511 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study of UroLift procedure in patients with lower urinary tract
symptoms in India |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 004, Version 1.1 dated 30.04.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Joshi |
| Designation |
Principle Investigator |
| Affiliation |
Aarna Super Speciality Hospital |
| Address |
Aarna Super Speciality Hospital,
Opp. Suvidha Shopping Centre, Near Parimal Underpass,Paldi, Ahmedabad
NA
Ahmadabad
GUJARAT
380007
India |
| Phone |
919824090609 |
| Fax |
|
| Email |
rohitjoshi1975@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Vijayendra |
| Designation |
Head – Clinical and Medical Affairs |
| Affiliation |
Teleflex Medical India Pvt Limited |
| Address |
Teleflex Medical India Pvt Ltd, M/S Smartwork co working space, Golden Millenium, 1st floor 69/3, 44 Millers Rd, Vasanth Nagar, Bengaluru
Bangalore
KARNATAKA
560052
India |
| Phone |
9902916500 |
| Fax |
|
| Email |
Vivek.Vijayendra@teleflex.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Vijayendra |
| Designation |
Head – Clinical and Medical Affairs |
| Affiliation |
Teleflex Medical India Pvt Limited |
| Address |
Teleflex Medical India Pvt Ltd, M/S Smartwork co working space, Golden Millenium, 1st floor 69/3, 44 Millers Rd, Vasanth Nagar, Bengaluru
Bangalore
KARNATAKA
560052
India |
| Phone |
9902916500 |
| Fax |
|
| Email |
Vivek.Vijayendra@teleflex.com |
|
|
Source of Monetary or Material Support
|
| Teleflex Medical India Pvt Ltd, M/S Smartwork co working space, Golden Millenium, 1st floor 69/3, 44 Millers Rd, Vasanth Nagar, Bengaluru - 560052 |
|
|
Primary Sponsor
|
| Name |
Teleflex Medical India Private Limited |
| Address |
Smartworks Coworking Space, Golden Millenium, 1st Floor
69/3, 44 Millers Rd, Vasanth Nagar, Bengaluru, Karnataka - 560052, India |
| Type of Sponsor |
Other [Medical Device] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohit Joshi |
Aarna Superspeciality Hospital |
Suvidha Shopping Center, Chimanlal Girdharlal Rd, Paldi, Ahmedabad, Gujarat 380007
Ahmadabad
GUJARAT |
9824090609
rohitjoshi1975@gmail.com |
| Dr Suresh Patankar |
ACE Hospital & Research Center |
S No- 32, 2A, Gulawani Maharaj Road, near Hotel Abhishek, Pandurang Colony, Erandwane, Pune, Maharashtra 411004
Pune
MAHARASHTRA |
9881256992
sureshpatankarace@gmail.com |
| Dr Raghavan N |
Apollo Hospitals |
Department of Urology, Greams Road, Chennai, Tamil Nadu 600006
Chennai
TAMIL NADU |
9952913740
ragavanurologist@gmail.com |
| Dr Vikram Baruah Kaushik |
Artemis Hospital |
Sector 51, Gurgaon
Gurgaon
HARYANA |
9871738547
drvikram.uro@gmail.com |
| Dr Sandeep Prabhakaran |
Aster Medcity |
South Chittor P O Cheranellor Kochi 682027, Kerala
Ernakulam
KERALA |
09745424111
sandyp25@gmail.com |
| Dr Ashish Saini |
Excel Advance Urology Centre |
C-34, Department of Urology, Ground Floor, Hansraj Gupta Rd, C Block, Greater Kailash I, New Delhi 110048
South
DELHI |
09868732531
drsaini.ak@gmail.com |
| Dr Mohan Keshavamurthy |
Fortis Hospital, Bannerghatta |
Department of Urology, Bannerghatta road, Opp to IIM-B, Bangalore-560076
Bangalore
KARNATAKA |
9980133003
minorcalyx@gmail.com |
| Dr Tanuj Paul Bhatia |
ILSS- Ashwani Hospital (Institute of Laser and Stone Surgery) |
Ground floor, Department of Urology, Sector 11, Faridabad, Haryana 121006
Faridabad
HARYANA |
7840071017
dr.tanujpaulbhatia@gmail.com |
| Dr Sanjay Pandey |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
Rao Saheb, Achutrao Patwardhan Marg, Four Bungalows, Andheri West, Mumbai, Maharashtra 400053
Mumbai
MAHARASHTRA |
9324718283
sanjay.pandey@kokilabenhospitals.com |
| Dr Anant Kumar |
Max Super speciality Hospital, Saket,West Block (A unit of Max healthcare institute limited) |
Max super speciality hospital, Saket (West Block) (A unit of Max Healthcare Institute Limited), 1, Press Enclave Road, Saket, New-Delhi: 110017, India
South
DELHI |
9968271880
anant.kumar@maxhealthcare.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Artemis Health Sciences Institutional Ethics Committee |
Approved |
| Conscience Independent Ethics Committee |
Approved |
| Fortis Hospital Institutional Ethics Committee |
Approved |
| Good Society for Ethical Research |
Approved |
| Good Society for Ethical Research |
Approved |
| Institutional Ethics Committee - Bio Medical Research Apollo Hospitals Chennai |
Approved |
| Institutional Ethics Committee ACE Hospital and Research Centre |
Approved |
| Institutional ethics Committee Aster Medcity |
Approved |
| Institutional Ethics Committee- Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute |
Approved |
| Max HealthCare Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Observational Study |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in IPSS score at 3 months from the baseline |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 baseline |
3 months |
|
|
Target Sample Size
|
Total Sample Size="145"
Sample Size from India="145"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |