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CTRI Number  CTRI/2024/03/064334 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 17/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the clinal outcome of one of the surgical technique i.e Autologous Fascia Lata Mid-urethral Sling with Polypropyelene Mesh Outside-in Transobturator Tape in the management Of Stress Urinary Incontinence. 
Scientific Title of Study   Clinical Efficacy Of Autologous Fascia Lata Mid-urethral Sling Versus Polypropyelene Mesh Outside-in Transobturator Tape In The Management Of Stress Urinary Incontinence 
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 Rajesh Kumari 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no. 729, Mother and Child Block, AIIMS, New Delhi
-
New Delhi
DELHI
110029
India 
Phone  9911226176  
Fax    
Email  drrajeshkumari@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Kumari 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no. 729, Mother and Child Block, AIIMS, New Delhi
-
New Delhi
DELHI
110029
India 
Phone  9911226176  
Fax    
Email  drrajeshkumari@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Arzoo Sana 
Designation  Junior Resident 
Affiliation  AIIMS, New Delhi 
Address  Room no. 729,OBGY Department, Mother and Child Block, AIIMS, New Delhi- New Delhi
-
New Delhi
DELHI
110029
India 
Phone  7204605550  
Fax    
Email  arzoosanaa@gmail.com  
 
Source of Monetary or Material Support  
All India Institue of Medical Sciences, Sri Aurbindo Marg, Ansari Nagar, Ansari Nagar East , New Delhi, 110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  All India Institute of Medical Sciences, Sri Aurbindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, 110029. 
Type of Sponsor  Government medical college 
 
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 
Dr Arzoo Sana  All India Institute of Medical Sciences  Obstetrics and Gynaecology, Mother and child block,7th floor, room no. 729,New Delhi, Ansarinagar
New Delhi
DELHI 		 7204605550

arzoosanaa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Autologous Fascia Lata Mid-urethral Sling  4cm S shaped incision is given horizontally just above and lateral to patella of thigh. Dissection done and Tensor Fascia Lata identified and approximately 1.5-2cm wide segment cut and 16 cm long Tensor Fascia Lata stripper harvested using stripper. Closure done in 2 layers, ASD done, crepe bandage applied. It is a 45mins to 1 hr procedure and patient gets discharged in 2-3 days of the procedure. After that follow up is done in 3 weeks and 3 months post-procedure.  
Comparator Agent  Polypropyelene Mesh Outside-in Transobturator Tape  .Mid-urethral sling procedures - polypropylene mesh is placed under the mid-urethra, the more critical continence zone - the open-weave mesh stabilizes and promotes ingrowth of the collagen over time .TOT - "outside in" placement of the mesh from the vagina through the obturator foramen out through the skin of the groin  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1.Women with Stress Urinary Incontinence requiring surgical management
2.Women who have completed their families
3.Willing to participate 
 
ExclusionCriteria 
Details  1.Previous failed surgeries for incontinence.
2.Vaginal prolapse requiring treatment.
3.Neurological disease like Parkinson’s disease, multiple sclerosis.
4.Bleeding diathesis.
5.History of spinal surgery.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•Urodynamically proven cure of SUI.

 		 0,6weeks,3months

 
 
Secondary Outcome  
Outcome  TimePoints 
1.Post-operative complication like post-operative urinary retension,SSI, UTI, any other urinary complaint in both the surgeries.
2.Improvement in the quality of life assessed by the Incontinence Impact Questionnaire
3.Operative time required for both the surgeries.  		 0,6weeks,3 month 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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 4 
Date of First Enrollment (India)   27/03/2024 
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)   Not Yet Recruiting 
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   Clinical  efficacy  of  Autologous Facia Lata Mid-Urethral Sling versus Polypropyelene mesh Outside-In Transobturator Tape in the management of Stress Urinary Incontinence.
This comparative study of Outside-in Transobturator Tape and Fascia Lata surgery in SUI will help us understanding which surgical procedure yields better outcome in terms of alleviating SUI symptoms. Investigating the comparative safety profiles will help in identify which procedure has lower rate of complication like mesh-related issues or post-operative pain. This study has not been conducted recently so research finding in this area can influence clinical guidelines and recommendation, shaping standard practices in the treatment of SUI.


 
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