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CTRI Number  CTRI/2023/11/060039 [Registered on: 20/11/2023] Trial Registered Prospectively
Last Modified On: 16/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of home based pelvic floor muscle training on bladder function among individuals with neurogenic bladder following spinal cord injury. 
Scientific Title of Study   Effect of unsupervised pelvic floor muscle training on urodynamic profile among individuals with neurogenic bladder following spinal cord injury: A Pilot Randomized Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivani Shrikrishnavilas Wattamwar  
Designation  PG student 
Affiliation  MGM Institute of Physiotherapy 
Address  MGM Institute of Physiotherapy N6 CIDCO Aurangabad

Aurangabad
MAHARASHTRA
431003
India 
Phone  7841046296  
Fax    
Email  shivaniwattamwar1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashwini Kale Rodge 
Designation  Professor HOD Department of Neurophysiotherapy 
Affiliation  MGM Institute of Physiotherapy 
Address  MGM Institute of Physiotherapy N6 CIDCO Aurangabad

Aurangabad
MAHARASHTRA
431003
India 
Phone  7263891882  
Fax    
Email  ashwinikalept@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Ashwini Kale Rodge 
Designation  Professor HOD Department of Neurophysiotherapy 
Affiliation  MGM Institute of Physiotherapy 
Address  MGM Institute of Physiotherapy N6 CIDCO Aurangabad

Aurangabad
MAHARASHTRA
431003
India 
Phone  7263891882  
Fax    
Email  ashwinikalept@yahoo.in  
 
Source of Monetary or Material Support  
MGM Institute of Physiotherapy Aurangabad 
 
Primary Sponsor  
Name  Shivani Shrikrishnavilas wattamwar 
Address  MGM Institute of Physiotherapy, N6 CIDCO Aurangabad 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shivani Wattamwar  Neurophysiotherapy OPD  MGM Institute of Physiotherapy and MGM Medical college and hospital, N6 CIDCO,Aurangabad, 431003
Aurangabad
MAHARASHTRA 		 7841046296

shivaniwattamwar1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGMIOP Institutional Ethical Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G959||Disease of spinal cord, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pelvic Floor Muscle Training  Pelvic Floor exercises will be taught to the individuals and will be continued by patients for 3 months along with the standard care.  
Comparator Agent  Standard Care  Standard care is given to this group which includes General Exercises, Counselling, Education, Dietary modifications, self-care, self-catheterization (if needed), medications. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Spinal cord injury patients with neurogenic bladder
2) Patients recovered from the spinal shock
3) Both male and female
4) Patients having ASIA score C or D.
5) Patient who are able to understand simple commands.
 
 
ExclusionCriteria 
Details  1) Neurogenic bladder associated with other neurological conditions.
2) Individuals having bladder dysfunction prior to spinal cord injury
3) Patients having other complications like urinary tract infection, hydronephrosis, kidney stones, etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Urodynamics  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
ASIA, Neurogenic bladder symptom score (NBSS) scale, overactive bladder symptom score (OABSS), Bladder Diary  3 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 1 
Date of First Enrollment (India)   27/11/2023 
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="2"
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   This study attempts to examine the effect of unsupervised pelvic floor muscle training among individuals with neurogenic bladder following spinal cord injury. ASIA Scale will be used as screening tool. Primary outcome is Urodynamic study in which pre and post intervention values will be compared among intervention and compatator groups. Secondary outcomes are neurogenic bladder symptom score(NBSS), Overactive bladder symptom score scale(OABSS) and bladder diary. Bladder diary will be maintained to record frequency, urgency. NBSS and OABSS will be assessed pre and post intervention and progression of urinary symptoms will be tracked. Pelvic floor muscle exercises will be taught to the intervention group along with standard care until they understand and able to perform and will be called to OPD if they face any problems. Follow up will be taken twice a week through phone calls. Comparator group will be taught standard care. All the outcomes will be assessed after 3 months of intervention. The data will be statistically analysed and result will be drawn. 
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