FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/101567 [Registered on: 19/01/2026] Trial Registered Prospectively
Last Modified On: 17/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of the efficacy of Uretero-renoscopic Lithotripsy with Extracorporeal Shock Wave Lithotripsy (ESWL) on clinical and patient-reported outcomes among patients with proximal ureteric stones 
Scientific Title of Study   Comparison of the efficacy of Uretero-renoscopic Lithotripsy with Extracorporeal Shock Wave Lithotripsy (ESWL) on clinical and patient-reported outcomes among patients with proximal ureteric stones- A Randomized Controlled Study. 
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 Rajat Ramesh Mudhol 
Designation  Senior Resident 
Affiliation  Jawahrlal Institute of Postgraduate Medical Education and Research 
Address  Department of Urology, 3rd floor, SSB building, JIPMER hospital, Dhanvantri nagar, Pondicherry, India

Pondicherry
PONDICHERRY
605005
India 
Phone  9743915177  
Fax    
Email  rajat.mudhol@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sreerag KS 
Designation  Additional Professor of Urology 
Affiliation  Jawaharlal institute of postgraduate medical education and research 
Address  Department of Urology, 3rd floor, SSB building, JIPMER hospital, Dhanvantri nagar, Pondicherry, India

Pondicherry
PONDICHERRY
605005
India 
Phone  6382159820  
Fax    
Email  sreeragks95@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.Rajat Ramesh Mudhol 
Designation  Senior Resident 
Affiliation  Jawahrlal institute of postgraduate medical education and research 
Address  Department of Urology, 3rd floor, SSB building, JIPMER hospital, Dhanvantri nagar, Pondicherry, India

Pondicherry
PONDICHERRY
605005
India 
Phone  9743915177  
Fax    
Email  rajat.mudhol@gmail.com  
 
Source of Monetary or Material Support  
jawaharlal institute of postgraduate medical education and research, city: Pondicherry, country: India PIN code: 605005 
 
Primary Sponsor  
Name  Rajat ramesh mudhol 
Address  department of urology, 3rd floor, SSB building, JIPMER hospital, dhanvantri. nagar, Pondicherry, India, 605005 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajat Mudhol  Jawaharlal institute of postgraduate medical education and research  Department of Urology 3rd floor SSB block Dhanvantri nagar Pondicherry 605005
Pondicherry
PONDICHERRY 
9743915177

rajat.mudhol@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Interventional Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N201||Calculus of ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Extracorporeal shake wave lithotripsy(ESWL)  A non surgical method in which shock waves are given externally by a machine to break the ureteric stones duration 30 minutes 
Intervention  Uretero-renoscopy  flexible or rigid scope is used to break the stones in the ureter with an energy source duration of the procedure will be 60 to 90 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with proximal ureteric calculi less than or equal to 1.5 cm, aged more than or equal to 18 years 
 
ExclusionCriteria 
Details  Distal obstruction (ureteric), multiple stones,bilateral stones,patients with contraindications for either ESWL or RIRS
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of Uretero-renoscopic lithotripsy with ESWL on stone clearance using NCCT among patients with proximal ureteric stones.  At 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare complications of Uretero-renoscopic lithotripsy with ESWL
2. Patient-reported outcome measures between the patients who have undergone Uretero-renoscopic lithotripsy versus ESWL for proximal ureteric stones. 
At 2 weeks 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   28/01/2026 
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="3"
Months="0"
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 with ureteric calculus measuring size less than 1.5 cm after standard clinical assessment and investigations will be assesed for eligibility to participate in the study. Those who are eligible based on the inclusion and exclusion criteria will be included in the study recruited into the study after informed consent,.

The patient will be randomized into the uretero-renoscopic lithotripsy or ESWL group as per allocation by the technique described above. 

Age, sex, demographic and clinical details will be noted down. 

 Patients will undergo URSL or RIRS by standard method by experienced urologists. Patient will undergo primary ureterorenoscopy and lithotripsy with 7 Fr ureterorenoscope and pneumatic/laser lithotripsy. Patients will be reassessed after discharge at the end of 2 weeks for development of any complications. The stone clearance will be assessed when the patient comes for follow up at 2 weeks with the help of X-ray KUB/ NCCT KUB (radiolucent stones). The patient reported outcome measures (Annexures no. 1 and 2) will be measured at 2 weeks. 

Patients in the ESWL group will undergo ESWL by Dornier compact alpha lithotripter III (Dornier MedTech System GmbH) under sedoanalgesia in the presence of urology senior resident and experienced urology technician. Patients will be assessed after 2 weeks with the help of X-RAY (radio-opaque stones) or NCCT (radiolucent stones). If stones are not cleared, they will be asked to undergo 2 more sessions. A maximum of only 3 sessions (4 weekly intervals) will be given to the patient. If stones are not cleared at the end of 3 sessions, it will be considered as an ESWL failure. Such patients will be advised to undergo RIRS or PCNL depending on the clinical assessment by the consultant. The PROMs will be measured 2 weeks after the end of the stone clearance session. The complications will also be noted down. 

Complete stone clearance will be considered when the residual calculus at the end of either interventions will be less than 3 mm

PROMs will be assessed with the help of EQ-5D-5L health questionnaire provided to the patients at the end of treatment in the language that they understand. The interview will be conducted after briefing them the purpose of the interview. Informed written consent will be obtained from each respondent before the interview. Confidentiality will be maintained for the data obtained as per ethical guidelines (Indian Council of Medical Research, 2000). Each patient will be asked to state the level of severity in each of the five domains based on the predefined condition. The severity level of each domain will be transformed into score by giving values for no problem as 0 and for mild, moderate, severe and extreme severe problem as 1, 2, 3 and 4, respectively. The values will be computerized for further analysis.


 
Close