| CTRI Number |
CTRI/2023/02/049759 [Registered on: 15/02/2023] Trial Registered Prospectively |
| Last Modified On: |
18/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the symptoms produced by a ureteral stent which is placed post surgery for stone disease. |
|
Scientific Title of Study
|
Ureteral stent related sympotms- A comparative study based on stent and patient characteristics |
| Trial Acronym |
StReSS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anurag Yadav |
| Designation |
Senior Consultant |
| Affiliation |
Pushpanjali Hospital |
| Address |
2nd Floor
Department of Urology
Agra
UTTAR PRADESH
282002
India |
| Phone |
9837039350 |
| Fax |
|
| Email |
anuraguro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anurag Yadav |
| Designation |
Senior Consultant |
| Affiliation |
Pushpanjali Hospital |
| Address |
2nd Floor
Department of Urology
Agra
UTTAR PRADESH
282002
India |
| Phone |
9837039350 |
| Fax |
|
| Email |
anuraguro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anurag Yadav |
| Designation |
Senior Consultant |
| Affiliation |
Pushpanjali Hospital |
| Address |
2nd floor
Department of Urology
Agra
UTTAR PRADESH
282002
India |
| Phone |
9837039350 |
| Fax |
|
| Email |
anuraguro@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pushpanjali Hospital and Research Centre
Delhi Gate
Agra
Uttar Pradesh
282002 |
|
|
Primary Sponsor
|
| Name |
Pushpanjali Hospital and Research Centre |
| Address |
Pushpanjali Hospital, Delhi Gate, Agra, Uttar Pradesh 282002 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Gaurav Sharma |
Pushpanjali Hospital and Research Centre |
2nd floor
department of urology
Agra
UTTAR PRADESH |
9855021981
sharmagauravpc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N209||Urinary calculus, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with stone disease.
Patients undergoing unilateral stenting. |
|
| ExclusionCriteria |
| Details |
Patients with any neurological condition
Patients with urinary tract malignancy
Patients with congenital urinary tract abnormality
Patients with comorbid urologic anatomical abnormalities, such as ureteral stricture
Pregnant or lactating females
Patients with known psychiatric illness
Patients who refused consent to participate in study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the prevalence and bother of various urinary tract symptoms caused by indwelling ureteral stents using validated questionnaire |
Patients symptoms will be assessed at time of stent removal approximately 4 weeks after endourological procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Overall incidence of various stent related symptoms in patients undergoing endourological treatment for stone disease.
Comparison of incidence of stent related symptoms with respect to different stent materials used.
Comparison of incidence of stent related symptoms with respect to different sizes of the stent used.
Impact of duration of stent, medication used and various other factors on ureteral stent related symptoms. |
Outcomes will be assessed after the removal of stent |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
20/02/2023 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Double J ureteric stenting has been one of the most common urological
procedures performed as an adjunct since its ï¬rst inception in 1978 . By
deï¬nition, the double-J or pigtail stent is a tube placed within the ureteral
lumen in a retrograde or antegrade fashion in order to drain an obstructed
kidney or to use as splint in ureteral repair and injury. The double-J ureteral
stent has been widely applied during the endourological surgery to relieve or
prevent ureteral obstruction. Stent-related morbidities, such as lower urinary
tract symptoms (LUTS), stent-related body pain and hematuria, are bothersome
and might have a negative impact on quality of life (QoL) and sexual
performance for both genders. In this study we will try to improve our understanding of relation
between various stent characteristics and symptoms associated with stenting. This
will help urologists in selecting stent for patients as well as counselling
patients preoperatively regarding their probability of experiencing stent related
symptoms. |