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Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence

Primary Purpose

Stress Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Autologous Transobturator Fascia Lata Sling
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 focused on measuring Autologous, TOT, SUI, Stress

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: Mixed incontinence with predominant Urge urinary incontinence. Associated local abnormalities that may affect surgery outcomes (e.g. complete procidentia). 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, ovarian cysts) 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 Fascia lata TOT

Arm Description

Through incision in the lower lateral aspect of the thigh, 4 cm above the knee, ~1 cm× ~5 cm fascial strip is isolated from the fascia lata. Two stay sutures are secured to the corners of the fascial segment on each side. About 1cm skin incision is performed at the thigh fold 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 of the fascial strip.

Outcomes

Primary Outcome Measures

complete cure
Number of patients without leakage with cough stress test and the patient is satisfied and on examination there is no leakage with cough test.

Secondary Outcome Measures

improvement of SUI
Number of patients who report leakage only with severe exertion and using a smaller number of pads per day and she feels that she has improved. On examination there is no stress urinary incontinence.

Full Information

First Posted
December 3, 2022
Last Updated
December 17, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05646745
Brief Title
Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence
Official Title
Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
May 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
No

5. Study Description

Brief Summary
To evaluate the outcome of autologous transobturator fascia lata sling for treatment of female stress urinary incontinence at Al-Azhar university hospitals.
Detailed Description
Following induction of anesthesia and administration of perioperative antibiotics, the patient is positioned in the dorsal lithotomy position, sterilization and draping will be done. A sterile 16 French 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 incision in the lower lateral aspect of the thigh, 4 cm above the knee, ~1 cm× ~5 cm fascial strip is isolated from the fascia lata. Two stay sutures are secured to the corners of the fascial segment on each side. About 1cm skin incision is performed at the thigh fold 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 of the fascial strip.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Autologous fascia lata is utilized via transobturator approach
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous Fascia lata TOT
Arm Type
Experimental
Arm Description
Through incision in the lower lateral aspect of the thigh, 4 cm above the knee, ~1 cm× ~5 cm fascial strip is isolated from the fascia lata. Two stay sutures are secured to the corners of the fascial segment on each side. About 1cm skin incision is performed at the thigh fold 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 of the fascial strip.
Intervention Type
Procedure
Intervention Name(s)
Autologous Transobturator Fascia Lata Sling
Intervention Description
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 incision in the lower lateral aspect of the thigh, 4 cm above the knee, ~1 cm× ~5 cm fascial strip is isolated from the fascia lata. Two stay sutures are secured to the corners of the fascial segment on each side. About 1cm skin incision is performed at the thigh fold 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 of the fascial strip.
Primary Outcome Measure Information:
Title
complete cure
Description
Number of patients without leakage with cough stress test and the patient is satisfied and on examination there is no leakage with cough test.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
improvement of SUI
Description
Number of patients who report leakage only with severe exertion and using a smaller number of pads per day and she feels that she has improved. On examination there is no stress urinary incontinence.
Time Frame
3 months

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: Mixed incontinence with predominant Urge urinary incontinence. Associated local abnormalities that may affect surgery outcomes (e.g. complete procidentia). 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, ovarian cysts) Genito-urinary malignancy. Current chemo or radiation therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed F Salman, MD
Phone
00201111788996
Email
Prof_mohamed_fawzy@yahoo.com
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, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence

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