| CTRI Number |
CTRI/2024/09/073950 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two drugs for decreasing pain after surgeries for bladder cancer |
|
Scientific Title of Study
|
Effect of oral flavoxate on postoperative catheter related bladder dysfunction in adult males undergoing transurethral resection of bladder tumors- A randomized controlled trial vs solifenacin and placebo |
| 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 Nandyala Tejeswar |
| Designation |
Academic Junior Resident |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No 409, Academic Block
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
7995896782 |
| Fax |
|
| Email |
tejeswarnandyala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyajeet Misra |
| Designation |
Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No 409, Academic Block
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyajeet Misra |
| Designation |
Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No 409, Academic Block
AIIMS Bhubaneswar
ORISSA
751019
India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar
Bhubaneswar 751019
Odisha |
|
|
Primary Sponsor
|
| Name |
Dr. Nandyala Tejeswar |
| Address |
Room No.409
Academic Block
AIIMS Bhubaneswar
Bhubaneswar 751019
Odisha, India |
| Type of Sponsor |
Other [Individual] |
|
|
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 Satyajeet Misra |
AIIMS Bhubaneswar |
Urology OT complex, Second floor
Post anesthesia care unit
Khordha
ORISSA |
9438884048
misrasatyajeet@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral flavoxate |
Oral flavoxate 200 mg administered orally in the preoperative area 2 hour prior to surgery |
| Comparator Agent |
Oral solifenacin |
Oral solifenacin 5 mg administered orally 2 hours prior to surgery |
| Comparator Agent |
Placebo |
Cornstarch filled capsule administered orally in the preoperative area 2 hours prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Adult males ASA 2 & 3, posted for elective transurethral resection of bladder tumor surgeries for non-invasive bladder tumors |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Psychosis
3. Patients on preoperative anti-muscarinic drugs
4. Arrhythmias
5. Patients with pre-operative catheters |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of postoperative catheter related bladder dysfunction |
At 6 hours postoperatively |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Incidence of postoperative catheter related bladder dysfunction |
At 0 hours[PACU] 1 hour, 2 hours, 12 hours & 24 hours postoperatively |
| Incidence of severe CRBD |
At 0[PACU], 1, 2, 6 , 12 & 24 hours postoperatively |
| Incidence of side effects of the flavoxate & solifenacin like dry mouth, constipation, headache, & dizziness |
At 24 hours postoperatively |
| Visual analog score |
At 0 hour [PACU], 1 hour, 2 hours, 6 hours, 12 hours & 24 hours postoperatively |
| Patient satisfaction with the interventions for decreasing catheter related bladder discomfort |
At 6 hours |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
17/09/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Catheter related bladder dysfunction (CRBD) is common in male patients after bladder surgery, and involves symptoms of overactive bladder (OAB) including urgency, hesitancy, and pain. Various mechanisms have been postulated for development of CRBD including contraction of the detrusor muscle secondary to acetylcholine release. CRBD is distressing to patients. Several treatment options are available like anti-muscarinics, anti-spasmodics, analgesics, etc. However, no drugs are free from side-effects. Oral flavoxate, an anti-spasmodic has been found to be useful in controlling symptoms of OAB. No previous studies have explored the role of oral flavoxate in managing symptoms of CRBD. Thus, this study aims to evaluate the effect of oral flavoxate vs oral solifenacin on CRBD symptom control, and also to study the side-effect profile of flavoxate vs solifenacin. |