| 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
|
|
|
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
|
|
|
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. |