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Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence

Primary Purpose

Stress Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Autologous rectus Fascia TOT
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women with genuine stress urinary incontinence. Mixed urinary incontinence with predominant stress element. Refractory cases to conservative therapy or patients who are not willing to consider (further) conservative treatment. Exclusion Criteria: Mild Stress urinary incontinence with improvement on conservative therapy or patients refusing surgical treatment. Mixed incontinence with predominant Urge urinary incontinence. Associated local abnormalities (e.g. cystocele). Recent or active urinary tract infection. Recent pelvic surgery. Neurogenic lower urinary tract dysfunction. Previous surgery for stress urinary incontinence. Pregnancy Less than 12 months post-partum. Other gynaecologic pathologies affecting bladder functions ( eg,large fibroids) Genito-urinary malignancy. Current chemo or radiation therapy.

Sites / Locations

  • Mohamed Fawzy SalmanRecruiting
  • Urology department - Alazhar universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous rectus Fascia TOT

Arm Description

A sterile Foley catheter is placed to drain the bladder, following this, injectable normal saline is utilized using 10 cc syringe for hydro-distention of the anterior vaginal wall, and a midline incision is made based on the mid-urethra. Dissection is carried out bilaterally to the obturator Foramen on both sides. Through Pfannestiel incision, ~1 cm× ~5 cm rectus fascia strip is isolated from the anterior rectus sheath. Two stay sutures are secured to the corner of the fascial segment on each side. Next, two separate trocar passages are performed on each side using a reusable C-shaped trocar, with care taken to ensure at least a 1 cm tissue bridge in the obturator membrane between the superior and inferior passes. Following this, the stay sutures are tied external to the obturator membrane on both sides, leaving the sling secured and flush with the mid-urethra. Sutures are also placed to secure the sling to the periurethral tissue to prevent rolling or migration

Outcomes

Primary Outcome Measures

Complete cure OR improvement of SUI
Complete cure means no leak on cough stress test and the patient in satisfied on "patient reported outcome". Improvement means patient reported leakage only with severe exertion and using a smaller number of pads per day and she feels that she has improved. On examination there was no stress urinary incontinence. Failure is considered when patients not fulfilling these criteria

Secondary Outcome Measures

Complications of Autologous TOT
Measured by clavien-Dindo scoring system
Estimated blood loss
Blood loss will be estimated by counting up the gauzes and towels used during the procedure [fully soaked gauze = 50 ml blood loss; half-soaked gauze = 30 ml blood loss; fully soaked towel = 150 ml blood loss; half-soaked towel = 75 ml blood loss] (Shorn, 2009).
Operative time
time consumption from induction of anesthesia till closure of vaginal mucosa

Full Information

First Posted
November 15, 2022
Last Updated
December 2, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05647070
Brief Title
Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence
Official Title
Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence, Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in most cases, so long-term outcomes needs to be verified.
Detailed Description
Stress urinary incontinence (SUI) is defined as involuntary passage of urine with rising intra-abdominal pressure. SUI is a common problem affecting 18-26.4% of women. Over the last two decades, SUI treatment has shifted to a mid-urethral sling (MUS) or a mesh-based bladder neck procedure. Although the surgery was believed to be relatively safe, there has been a steep rise in the number of reported cases of their erosion into the lower urinary tract. Several options outside of synthetic mid-urethral sling placement exist, such as the autologous pubovaginal sling, biologic grafts, or urethral bulking agent injection. Each has its limitations, whether related to morbidity or efficacy. The autologous slings most commonly used are the fascia lata and the rectus fascia, and they are placed at the urethra-vesical junction through the 'retropubic' approach. In an attempt to present the benefits of a "transobturator" surgical approach and avoiding risks associated with synthetic sling material, Linder and Elliott, 6performed a novel technique for autologous urethral sling placement via a" trans obturator" approach for managing female SUI. Autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in most cases. Notably, no patients had post-operative voiding dysfunction that necessitated sling release, and there were no major (Clavien III-V) complications.The aim of this study is to report long-term transobturator sling outcomes using autologous rectus fascia for SUI in women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A sterile Foley catheter is placed to drain the bladder, following this, injectable normal saline is utilized using 10 cc syringe for hydro-distention of the anterior vaginal wall, and a midline incision is made based on the mid-urethra. Dissection is carried out bilaterally to the obturator Foramen on both sides. Through Pfannestiel incision, ~1 cm× ~5 cm rectus fascia strip is isolated from the anterior rectus sheath. Two stay sutures are secured to the corner of the fascial segment on each side. Next, two separate trocar passages are performed on each side using a reusable C-shaped trocar, with care taken to ensure at least a 1 cm tissue bridge in the obturator membrane between the superior and inferior passes. Following this, the stay sutures are tied external to the obturator membrane on both sides, leaving the sling secured and flush with the mid-urethra. Sutures are also placed to secure the sling to the periurethral tissue to prevent rolling or migration
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous rectus Fascia TOT
Arm Type
Experimental
Arm Description
A sterile Foley catheter is placed to drain the bladder, following this, injectable normal saline is utilized using 10 cc syringe for hydro-distention of the anterior vaginal wall, and a midline incision is made based on the mid-urethra. Dissection is carried out bilaterally to the obturator Foramen on both sides. Through Pfannestiel incision, ~1 cm× ~5 cm rectus fascia strip is isolated from the anterior rectus sheath. Two stay sutures are secured to the corner of the fascial segment on each side. Next, two separate trocar passages are performed on each side using a reusable C-shaped trocar, with care taken to ensure at least a 1 cm tissue bridge in the obturator membrane between the superior and inferior passes. Following this, the stay sutures are tied external to the obturator membrane on both sides, leaving the sling secured and flush with the mid-urethra. Sutures are also placed to secure the sling to the periurethral tissue to prevent rolling or migration
Intervention Type
Procedure
Intervention Name(s)
Autologous rectus Fascia TOT
Intervention Description
A sterile Foley catheter is placed to drain the bladder, following this, injectable normal saline is utilized using 10 cc syringe for hydro-distention of the anterior vaginal wall, and a midline incision is made based on the mid-urethra. Dissection is carried out bilaterally to the obturator Foramen on both sides. Through Pfannestiel incision, ~1 cm× ~5 cm rectus fascia strip is isolated from the anterior rectus sheath. Two stay sutures are secured to the corner of the fascial segment on each side. Next, two separate trocar passages are performed on each side using a reusable C-shaped trocar, with care taken to ensure at least a 1 cm tissue bridge in the obturator membrane between the superior and inferior passes. Following this, the stay sutures are tied external to the obturator membrane on both sides, leaving the sling secured and flush with the mid-urethra. Sutures are also placed to secure the sling to the periurethral tissue to prevent rolling or migration
Primary Outcome Measure Information:
Title
Complete cure OR improvement of SUI
Description
Complete cure means no leak on cough stress test and the patient in satisfied on "patient reported outcome". Improvement means patient reported leakage only with severe exertion and using a smaller number of pads per day and she feels that she has improved. On examination there was no stress urinary incontinence. Failure is considered when patients not fulfilling these criteria
Time Frame
one year
Secondary Outcome Measure Information:
Title
Complications of Autologous TOT
Description
Measured by clavien-Dindo scoring system
Time Frame
one year
Title
Estimated blood loss
Description
Blood loss will be estimated by counting up the gauzes and towels used during the procedure [fully soaked gauze = 50 ml blood loss; half-soaked gauze = 30 ml blood loss; fully soaked towel = 150 ml blood loss; half-soaked towel = 75 ml blood loss] (Shorn, 2009).
Time Frame
24 hours
Title
Operative time
Description
time consumption from induction of anesthesia till closure of vaginal mucosa
Time Frame
2 hours

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with genuine stress urinary incontinence. Mixed urinary incontinence with predominant stress element. Refractory cases to conservative therapy or patients who are not willing to consider (further) conservative treatment. Exclusion Criteria: Mild Stress urinary incontinence with improvement on conservative therapy or patients refusing surgical treatment. Mixed incontinence with predominant Urge urinary incontinence. Associated local abnormalities (e.g. cystocele). Recent or active urinary tract infection. Recent pelvic surgery. Neurogenic lower urinary tract dysfunction. Previous surgery for stress urinary incontinence. Pregnancy Less than 12 months post-partum. Other gynaecologic pathologies affecting bladder functions ( eg,large fibroids) Genito-urinary malignancy. Current chemo or radiation therapy.
Facility Information:
Facility Name
Mohamed Fawzy Salman
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed F Salman, MD
Phone
+201111788996
Email
prof_mohamed_fawzy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Aboelfotoh A Aboelfoth, MD
Facility Name
Urology department - Alazhar university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed F Salman, MD
Phone
+201111788996
Email
prof_mohamed_fawzy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohamed F Salman
Phone
+201111788996
Email
prof_mohamed_fawzy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Aboelfotoh A Aboelfotoh, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence

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