TO COMPARE THREE TYPES OF SURGERIES IN PATIENTS WITH STRESS URINARY INCONTINENCE

Phase 3

Not yet recruiting

Conditions: Other intraoperative and postprocedural complications and disorders of genitourinary system,

Registration Number: CTRI/2019/12/022362

Lead Sponsor: Indian Council of Medical Research

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-Î± (TNF-Î±) 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 180

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): All India Institute of Medical Sciences
🇮🇳
Delhi, DELHI, India
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr J B Sharma
Principal investigator
09868397309
jbsharma2000@gmail.com