| CTRI Number |
CTRI/2020/04/024945 [Registered on: 30/04/2020] Trial Registered Prospectively |
| Last Modified On: |
22/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trail to study the effects of alpha blocker tamsulosin and drug combination alpha blocker tamsulosin and competitive muscarinic-receptor antagonist solifenacin in treatment with ureteral stent related lower urinary tract symptoms. |
|
Scientific Title of Study
|
Effects of tamsulosin and tamsulosin + solifenacin combination therapy in treatment of ureteral stent related lower urinary tract symptoms. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANKIT ANAND |
| Designation |
UROLOGY RESIDENT |
| Affiliation |
Dr.Pinnameneni shiddharta institute of medical science and research foundation |
| Address |
Super specialty building , Urology department, first floor,Dr. pinnameneni sidhharta institute of medical sciences and research foundation campus ,chinnaoutpalli, gannavaram
Super specialty building , Urology department, first floor,Dr. pinnameneni sidhharta institute of medical sciences and research foundation campus ,chinnaoutpalli, gannavaram
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9177618303 |
| Fax |
|
| Email |
DR.ANKITANAND19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
D SREEDHAR |
| Designation |
PROFESSOR |
| Affiliation |
dr.Pinnameneni shiddharta institute of medical science and research foundation |
| Address |
Super specialty building , Urology department, first floor,Dr. pinnameneni sidhharta institute of medical sciences and research foundation campus ,chinnaoutpalli, gannavaram
Super specialty building , Urology department, first floor,Dr. pinnameneni sidhharta institute of medical sciences and research foundation campus ,chinnaoutpalli, gannavaram
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9177618303 |
| Fax |
|
| Email |
sreedh2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
D SREEDHAR |
| Designation |
PROFESSOR |
| Affiliation |
Dr.Pinnameneni shiddharta institute of medical science and research foundation |
| Address |
Super specialty building , Urology department, first floor,Dr. pinnameneni sidhharta institute of medical sciences and research foundation campus ,chinnaoutpalli, gannavaram
Super specialty building , Urology department, first floor,Dr. pinnameneni sidhharta institute of medical sciences and research foundation campus ,chinnaoutpalli, gannavaram
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9177618303 |
| Fax |
|
| Email |
sreedh2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. PSIMS AND RF
dr. Pinnamaneni Siddhartha institute of medical science and research foundation campus, chhinoutpalli, gannavaram ,vijayavada, krishana district, andrapradesh |
|
|
Primary Sponsor
|
| Name |
ankit |
| Address |
Dr. pinnameneni sidhharta institute of medical sciences and research foundation campus ,chinnaoutpalli, gannavaram, andra pradesh |
| 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 |
| Ankit anand |
Dr. PSIMS AND RF |
Super specialty building , Urology department, first floor,Dr. pinnameneni sidhharta institute of medical sciences and research foundation campus ,chinnaoutpalli, gannavaram, andra pradesh
Krishna
ANDHRA PRADESH |
8601304196
Dr.ankitanand19@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR.PSIMS &RF -IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N22||Calculus of urinary tract in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing Double-J stenting for ureteral intervention were included in the study. |
|
| ExclusionCriteria |
| Details |
1-Patients who were previously diagnosed with benign prostatic hyperplasia or overactive bladder.
2-Pregnant women.
3- Psychiatric illness
4-Urinary tract infections.
5-Previous use of selective alpha-1- blocker and or antimuscarinic agent or with known history of orthostatic hypotension,allergy,hypersensitivity to one or more alpha blockers.
6-Patients under ICU management
7-Patients on dialysis.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. International Prostate Symptom Score/quality of life
2.visual analogue pain scale |
1. On the day of PER URETHRAL CATHETER REMOVAL
2.On the day of DJ stent removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. STORAGE SYMPTOMS IMPROVEMENT
2. VOIDING SYMPTOMS IMPROVEMENT |
1. on the day of per urethral catheter Removal
2. on the day of DJ stent removal |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2020 |
| Date of Study Completion (India) |
20/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
10.33545/surgery.2021.v5.i4c.779 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
To analyse the effectiveness of selective alpha -1-blocker tamsulosin and combination of alpha -1-blocker tamsulosin plus competitve muscarinic receptor antagonist solifenacin in improving the lower urinary tract symptoms of patients with double J ureteral stents |