| CTRI Number |
CTRI/2024/10/074973 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
It is study to see result of surgery done for incontinence of urine on coughing and sneezing depending upon tissue used (either from abdomen or from thigh) |
|
Scientific Title of Study
|
A Comparative Analysis Of Perioperative And Functional Outcome Of Autologus Rectus Fascia Sling Vs Fascia Lata Sling In The Surgical 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 J B Sharma |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
room no 3064 A, Teaching block, Department of Obstetrics and Gynecology, AIIMS New Delhi
East
DELHI
110029
India |
| Phone |
9868138205 |
| Fax |
|
| Email |
jbsharma2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J B Sharma |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 3064 A, teaching block, Department of Obstetrics and Gynecology, AIIMS New Delhi
East
DELHI
110029
India |
| Phone |
9868138205 |
| Fax |
|
| Email |
jbsharma2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha |
| Designation |
Fellow Urogynecology |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Obstetrics and Gynecology, AIIMS New Delhi
East
DELHI
110029
India |
| Phone |
7992322975 |
| Fax |
|
| Email |
preety.nisha22@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar East, NEW DELHI-110029 |
|
|
Primary Sponsor
|
| Name |
Institute based research |
| Address |
All India Institute of Medical Sciences, Ansari Nagar East New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nisha |
AIIMS New Delhi |
room no 3064 A, Teaching block,
Ansari Nagar East
New Delhi-110029
East
DELHI |
7992322975
preety.nisha22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee for postgraduate research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N393||Stress incontinence (female) (male), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologous rectus fascia sling |
Patient placed in lithotomy position. Pfannenstiel incision given over abdomen and dissection done till rectus sheath. Prolene suture tied to ends of sling. Vaginally paraurethral dissection done and sling then passed from vagina to abdomen by Kelly’s clamp. The ends of prolene suture tied over rectus sheath . Rectus sheath closure done and abdomen then closed after putting subcutaneous drain.vaginal incision also closed. outcome will be assessed 2weeks, 6weeks, 12 weeks |
| Comparator Agent |
Fascia Lata sling |
Fascia Lata will be harvested from thigh area after giving incision 2 cm above knee joint. Prolene suture tied to both ends. Paraurethral dissection done. Sling then passed from vagina to groin region and same procedure repeated on other sides. Vaginal and thigh incision closed. Follow up will be done after 2 weeks, 6 weeks and 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Women with proven stress urinary incontinence
2. No symptom relief after PFMT( pelvic floor muscle training)
3. Written informed consent |
|
| ExclusionCriteria |
| Details |
1. Previous surgeries for incontinence or prolapse
2. Concomitant vaginal prolapse greater than stage 2 according to POP Q System
3. Uncontrolled overactive bladder symptoms
4. Neurological diseases like Parkinson’s disease, multiple sclerosis
5. Bleeding diathesis |
|
|
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 |
| Efficacy of two surgical procedures for cure of SUI |
6 weeks , 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Postoperative complications like blood loss, length of hospital stay, wound complication like infection or ,Sedona formation, readmission, PVR VOLUME, URINARY RETENTION AND NEED For catheterisation or de novo urinary complaint
2. To assess difficulty in daily activities via functional pain assessment score
3.To assess the quality of life per and post operatively |
2 weeks, 6weeks, 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
21/10/2024 |
| 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="0"
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
|
This study is to compare the surgical outcome as well as the perioperative and post-operative complications, that arise from using autologous fascia harvested from either the rectus fascia or the fascia lata. The purpose of this comparison is to determine success rate of both surgery and which harvest site has lower complication rates. By analyzing and evaluating these outcomes, we hope to provide valuable insights into the most effective and efficient methods of using autologous fascia in surgical management of SUI. Ultimately, our goal is to improve patient outcomes and reduce complication rates by identifying the optimal harvest site for autologous fascia. |