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
|
|
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
|
|
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. |