| CTRI Number |
CTRI/2025/04/083790 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Randomized Control Study of bladder catheterization vs
non-catheterization in patients post semirigid Ureterorenoscopic Lithotripsy (URSL) with DJ stenting. |
|
Scientific Title of Study
|
Randomized Control Study of patients post semirigid Ureterorenoscopic
Lithotripsy (URSL) with DJ stenting undergoing bladder catheterization vs
non-catheterization. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harsh Dinesh Bhalsod |
| Designation |
Registrar |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Urology and Renal Transplant, Kasturba Medical College, Tiger circle Road, Madhav Nagar, Eshwar Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9164118514 |
| Fax |
|
| Email |
bhalsodharsh94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Pillai |
| Designation |
Professor and HOD |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Urology and Renal Transplant, Kasturba Medical College, Tiger circle Road, Madhav Nagar, Eshwar Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9731855209 |
| Fax |
|
| Email |
sunil.pillai@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsh Dinesh Bhalsod |
| Designation |
Registrar |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Urology and Renal Transplant, Kasturba Medical College, Tiger circle Road, Madhav Nagar, Eshwar Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9164118514 |
| Fax |
|
| Email |
bhalsodharsh94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Madhavnagar, Manipal, Udupi-576104, Karnataka |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College and Hospital Manipal |
| Address |
Department of Urology and Renal Transplant, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harsh Dinesh Bhalsod |
Kasturba Hospital, Manipal |
Department of Urology and Renal Transplant, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9164118514
bhalsodharsh94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N201||Calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bladder catheterization |
Foleys catheter in control group patient Foleys 14 Fr in females and males |
| Comparator Agent |
Non-catheterization |
Patients will be randomised into groups after undergoing URSL and DJ stenting. Both the groups will be looked for post operative pain, IPSS, USSQ and post operative complications. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
URSL performed under general/spinal anesthesia with insertion of Double J ureteral stent
Foleys catheter in the control group patient - Foleys no 14 in females and males |
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Bilateral URSL
URSL without stenting
Previous history of URSL
Pre existing urethral/Bladder outlet pathology |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
International Prostate Symptom Score (IPSS).
Post-operative pain, Visual Analogue Scale (VAS)
Ureteric Stent Symptomatic Score (USSQ) |
Pre-operatively, Post operative POD 0 (6hrs), POD 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative fever more than 100 degree
USG for Hydronephrosis, Post Void Residue (PVR) seen before discharge
Emergency visits, readmission after discharge
Any history of lithuria |
Pre operatively, Post operative day POD 0 at 6 hr, POD1. |
|
|
Target Sample Size
|
Total Sample Size="141"
Sample Size from India="141"
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)
|
15/04/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Patients presenting to Kasturba Hospital Manipal, Department of urology and Renal Transplant with ureteric calculi will be recruited from the OPD for the study. Informed consent will be taken. Lithotripsy will be done with pneumatic lithotripter or Laser as per surgeons’ preference. Clearance of stone fragments will be confirmed on ureteroscopy and fluoroscopy. Then, Patients will be randomized into 2 groups by using simple computer-generated randomization Group 1 patients (control group) will undergo Bladder catheterization and Group 2 patients (study group) will not be subjected to a catheter. All patients will be evaluated for post operative pain, fever, IPSS and USSQ- pre operatively, POD0- at 6 hr (from the time the patient fully awakens from general anesthesia or regains motor control after spinal anesthesia) and on POD1. All patients will be prescribed oral antibiotics for one week and oral analgesics for 7 days post discharge. Ultrasonography of the patients will be done just before the discharge to measure PVR and hydronephrosis. |