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CTRI Number  CTRI/2019/12/022362 [Registered on: 13/12/2019] Trial Registered Prospectively
Last Modified On: 10/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   TO COMPARE THREE TYPES OF SURGERIES IN PATIENTS WITH STRESS URINARY INCONTINENCE 
Scientific Title of Study   A RANDOMIZED CONTROLLED TRIAL OF A STUDY COMPARING AUTOLOGOUS RECTUS FASCIA PUBOVAGINAL SLING VERSUS MID-URETHRAL SLING VERSUS BURCH COLPOSUSPENSION PROCEDURE IN WOMEN WITH STRESS URINARY INCONTINENCE 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JAI BHAGWAN SHARMA 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No 3064 A , III Floor teaching Block , Department of Obstetrics and Gynecology, AIIMS, New Delhi

New Delhi
DELHI
110016
India 
Phone  9868397309  
Fax    
Email  jbsharma2000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  JAI BHAGWAN SHARMA 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No 3064 A, III Floor Teaching Block , Department of Obstetrics and Gynecology, AIIMS, New Delhi

New Delhi
DELHI
110016
India 
Phone  9868397309  
Fax    
Email  jbsharma2000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  JAI BHAGWAN SHARMA 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No 3064 A , III Floor Teaching Block , Department of Obstetrics and Gynecology, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9868397309  
Fax    
Email  jbsharma2000@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, Ansari Nagar, New Delhi, 110029 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Ansari Nagar New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr J B Sharma  All India Institute of Medical Sciences  Dept of Obstetrics and Gynecology AIIMS New Delhi
New Delhi
DELHI 
09868397309

jbsharma2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Urodynamic studies IL6 & CRP levels All preoperative investigations   UDS will be done preoperatively and then 6 weeks postoperatively. IL6 &CRP levels will be done 24 hours before surgery & 7 days postoperatively 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Age 25-65years
Women with urodynamically proven stress urinary incontinence
Parous patients preferably those who have completed their families
Failed Medical management for SUI
No significant medical problems Uncontrolled DM HTN Cardiac disease
Willing to participate in the study
 
 
ExclusionCriteria 
Details  Previous failed surgical management of SUI
Previous surgery for incontinence or prolapse
Vaginal prolapse requiring treatment
Associated Neurological diseases like Parkinson s disease Multiple sclerosis
Detrusor Overactivity
History of Spinal surgery
Diuretic use
Bleeding Diathesis
Not willing to participate in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the success rate of treatment of Stress urinary incontinence with Autologous Pubovaginal Fascial Sling versus Mid-Urethral Sling versus Burch Colposuspension in Women with Urodynamically proven Stress urinary incontinence.   After 6 months of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy success rate and complication rate and quality of life score of the three surgical procedures in the Department of Obstetrics and Gynecology and Urology who have the adequate experience and infrastructure to perform the three procedures and look after these patients  after surgery 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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 3/ Phase 4 
Date of First Enrollment (India)   20/12/2019 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Abrams P Cardozo L Khoury S Incontinence Third International Consultation on Incontinence Monaco 2004 Public Health Publication 2005 p 286 Sharma JB Urinary Incontinence in Textbook of Gynaecology Avichal Publication company New Delhi 1stedn 2018 P392 429 Sharma J B Aggarwal S Singhal S Kumar S Roy KK Prevalence of urinary incontinence and other urological problems during pregnancy a questionnaire based study Arch Gynecol Obstet 2009 279 6 84551 Dooley Y Kenton K Cao G et al Urinary incontinence prevalence results from the National Health and Nutrition Examination Survey J Urol 2008 179 2 65661 Tennstedt SL Link CL Steers WD Mckinlay JB Prevalence of and risk factors for urine leakage in a racially and ethnically diverse population of adults the Boston Area Community Health BACH Survey Am J Epidemiol 2008167 4 390 9  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Stress Urinary Incontinence is defined as the involuntary  leakage  of urine which occurs during efforts that increase the intra-abdominal pressure such as during coughing, sneezing or even during exercise. It occurs when the urinary bladder pressure exceeds the urethral pressure. It is mainly caused due to the loss of urethral support, usually as a consequence of damage to pelvic structures during delivery. McGuire classification system describes 3 types of SUI. Type 1 and 2 occur due to urethral hypermobility and type 3 occurs due to intrinsic sphincter deficiency. The prevalence of SUI among adult women varies between studies, but it may be as high as 25% . Patients should be seen by a Urogynaecologist and a careful history with regards to voiding, urine leakage, frequency, urgency, straining, discomfort, use of drugs and recent surgery should be taken.

Surgical trauma acts as a stimulus for acute-phase response (APR) and is thought to be mediated through cytokines such as interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and C-reactive protein (CRP). Serum IL-6 levels are an easily measurable  marker and has been shown to correlate with the severity of  the tissue trauma, blood loss, and the duration of surgical procedure.Among all the available markers, IL-6 correlates best with the magnitude of injury and the systemic inflammatory response. It is thought to be the primary mediator of inflammation and regulator of the hepatic production of CRP. Comparison of preoperative and postoperative serum inflammatory markers can help to assess the stress response of the body in terms of the severity of tissue trauma with different procedures and establish the better choice.


 
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