| CTRI Number |
CTRI/2024/11/077322 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the comparative effects of two drugs solifenacin & duloxetine for the patients with spinal cord injury & its effects on neurogenic overactive bladder. |
|
Scientific Title of Study
|
Comparative study of solifenacin as monotherapy versus solifenacin with duloxetine as combination therapy in neurogenic overactive bladder among supra-sacral spinal cord injury patients: An open label randomized clinical trial. |
| Trial Acronym |
IRB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rejuwan Hussain |
| Designation |
Academic JR Postgraduate |
| Affiliation |
AIIMS JODHPUR |
| Address |
AIIMS Jodhpur Department of PMR
OPD cum chamber room no 2
Rajasthan India 342005
AIIMS Jodhpur PMR departmental Seminar hall room no 14 Rajasthan India 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8876749440 |
| Fax |
|
| Email |
hussainrejuwan2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Gaur |
| Designation |
Additional Professor & HOD |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of PMR AIIMS JODHPUR
Ground floor nearby medical college building
PMR Office Room no 12
OPD Cum Chamber room no 15
Rajasthan India 342005
Department of Physical Medicine & Rehabilitation
PMR Office Room no 12
OPD Cum Chamber room no 15
Rajasthan India 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8299711753 |
| Fax |
|
| Email |
ravisms80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Gaur |
| Designation |
Additional Professor & HOD |
| Affiliation |
AIIMS JODHPUR |
| Address |
AIIMS Jodhpur Department of PMR
Ground floor nearby medical college building
OPD cum chamber room no 15
PMR Office hall no 12
Rajasthan India 342005
Department of Physical Medicine & Rehabilitation
OPD cum chamber room no 15
PMR Office hall no 12
Rajasthan India 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8299711753 |
| Fax |
|
| Email |
ravisms80@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS JODHPUR
Basni Industrial area phase 2 Rajasthan India 342005 |
|
|
Primary Sponsor
|
| Name |
DR REJUWAN HUSSAIN |
| Address |
AIIMS Jodhpur Basni Industrial area phase 2 PMR department OPD 2 Seminar hall 14 Rajasthan India 342005 |
| 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 REJUWAN HUSSAIN |
AIIMS JODHPUR HOSPITAL |
Department of PMR
PMR ward IPD 1A & 2A block & PMR OPD room no 1 2 5 6 & 15 Ground floor AIIMS Jodhpur Basni Rajasthan India 342005
Jodhpur
RAJASTHAN |
8876749440
hussainrejuwan2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE CLINICAL TRIAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G952||Other and unspecified cord compression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SOLIFENACIN MONOTHERAPY VERSUS SOLIFENACIN WITH DULOXETINE AS COMBINATION THERAPY |
Intervention: To give Solifenacin 5 mg once daily after breakfast as monotherapy to control group or group A versus Solifenacin of same dose & frequency with Duloxetine 40 mg twice daily after breakfast & after dinner as combination therapy to test group or group B. Follow up at 4th weeks & 8 weeks after treatment using OAB-V8 PHQ-9 tool & UDS findings & comparision to the baseline visit at week 1st.
|
| Intervention |
Urodynamic Study |
Urodynamic Assessment:
In the department of Paediatric Surgery at AIIMS Jodhpur we will use the MMS/Laborie NEXAM PRO Urodynamic System equipment to conduct our urodynamic assessments for the patients. Under the guidance of urologists & physiatrists, UDS reports will be interpreted for clinical correlation accordingly.
According to the guidelines for good urodynamic practice, it will be carried out with strict aseptic preacution, counselling, and verbal consent. The patient is going to be on supine position. The transurethral double-lumened 10-French catheter will be used to fill the bladder and record the intravesical pressure. A rectal indwelling catheter (model number 14-French) will be used to record internal pressure. The bladder will be filled at a rate of 20 cc/min until the detrusor leak point is achieved or until the patient experiences a sensation that would ordinarily cause the bladder to evacuate immediately. Sterile saline solution 0.9% at body temperature is utilised as the filling medium. Additionally, sphincter electromyography (EMG) will be carried out.
Measurement & evaluation of the following urodynamic parameters will be performed –
-Total bladder capacity
-Detrusor compliance
-Leak point pressure
-Maximum Detrusor pressure
-Post void residual |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age- above 18 years of age till 65 years of age, of either sex.
2.Patients with neurogenic overactive bladder in last more than 3 months.
3.Diagnosed cases of supra-sacral SCI with or without paraplegia.
4.Supra-sacral SCI patients with indwelling catheter.
5.Supra-sacral SCI patients with self-voiding bladder.
6.Supra-sacral SCI Patients on CIC.
7.Patients not taking any other medications for neurogenic bladder. |
|
| ExclusionCriteria |
| Details |
1.PATIENTS WITH IMPAIRED HEPATIC OR RENAL FUNCTIONS
2.PATIENTS WITH UNCONTROLLED HYPERTENSION & NARROW ANGLE GALUCOMA
3.PATIENTS WITH COGNITIVE IMPAIRMENTS
4. PREGNANT & LACTATING FEMALES
5. PATIENTS WITH NEUROPSYCHIATRIC DISORDER
6.PATIENTS WITH BLADDER STONE,UTI,HYDROURETERONEPHROSIS
7.PATIENTS TAKING OTHER MEDICINES FOR NEUROGENIC BLADDER |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare effects of Solifenacin monotherapy in neurogenic overactive bladder in terms of clinical improvement of OAB symptoms after treatment at 4th & 8th weeks using OAB-V8 questionnaire. |
Baseline visit at week 1st
2nd visit at week 4th &
3rd visit at week 8th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare effects of Solifenacin as monotherapy versus solifenacin with duloxetine as combination therapy on urodynamic study parameters- MDP, LPP, PVR, TBC, DC at 4th weeks & 8th weeks of treatment in neurogenic overactive bladder among suprasacral SCI patients.
2.To compare the treatment impact on quality of life using OAB-qSF symptom bother & PHQ-9 questionnaires at 4th weeks & 8th weeks of treatment in neurogenic overactive bladder among suprasacral SCI patients.
3.To assess the safety profile by listing adverse effects of Solifenacin versus Solifenacin with Duloxetine in neurogenic overactive bladder among suprasacral SCI patients at 4th weeks & 8th weeks of treatment. |
Baseline visit at 1st week
2nd visit at 4th weeks &
3rd visit at 8th weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
05/12/2024 |
| 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="0"
Months="11"
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
|
Summary: After fullfillment of inclusion & exclusion criterias , patients with supra-sacral spinal cord injury with neurogenic bladder reporting to the department of PM&R, AIIMS Jodhpur during the study period will be enrolled to give Solifenacin as monotherapy to control group versus Solifenacin with Duloxetine as combination therapy to the test group to compare the effectiveness & safety of solifenacin versus solifenacin with duloxetine. Comparatively solifenacin with duloxetine as combination therapy will be more effective over solifenacin as monotherapy in neurogenic overactive bladder among suprasacral spinal cord injury patients in terms of clinical improvement in OAB symptoms, improvement of urodynamic study parameters & overall quality of life. Primary Objective: To compare effects of Solifenacin monotherapy in neurogenic overactive bladder in terms of clinical improvement of OAB symptoms after treatment at 4th & 8th weeks using OAB-V8 questionnaire. Secondary Objectives: 1. To compare effects of Solifenacin as monotherapy versus solifenacin with duloxetine as combination therapy on urodynamic study parameters- MDP, LPP, PVR, TBC, DC at 4th weeks & 8th weeks of treatment in neurogenic overactive bladder among suprasacral SCI patients. 2. To compare the treatment impact on quality of life using OAB-qSF symptom bother & PHQ-9 questionnaires at 4th weeks & 8th weeks of treatment in neurogenic overactive bladder among suprasacral SCI patients. 3. To assess the safety profile by listing adverse effects of Solifenacin versus Solifenacin with Duloxetine in neurogenic overactive bladder among suprasacral SCI patients at 4th weeks & 8th weeks of treatment. Purpose of the study : Since there is no study available for neurogenic overactive bladder among suprasacral spinal cord injury patients comparing effectiveness & safety of solifenacin as monotherapy versus solifenacin with duloxetine as combination therapy in terms of clinical improvement of OAB symptoms, urodynamic study (UDS) assessment , quality of life (QOL) assessment & overall drug safety in SCI patients.This study interpretation will be helpful in improving the management of neurogenic overactive bladder among suprasacral spinal cord injury patients & will impact the overall quality of life in such paraplegic disabled patients. |