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Hybrid Versus Synthetic TOT for Treatment of SUI

Primary Purpose

Female Stress Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transobturator tape
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Stress Incontinence

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically proven SUI or stress-predominant mixed urinary incontinence by cough stress test.

Exclusion Criteria:

  • • Patients with neurogenic voiding dysfunction.

    • History of anti-incontinence surgery.
    • Presence of urge-predominant mixed urinary incontinence.
    • Peripheral neuropathy.
    • Multiple sclerosis.
    • History of urogenital cancer.
    • Pelvic irradiation
    • Body mass index more than 40 kg/m2
    • The presence of more than stage 2 pelvic organ prolapse as per pelvic organ prolapse quantification (POP-Q) system score.
    • Active urinary tract infection
    • Pregnant women

Sites / Locations

  • Alexandria Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hybrid transobturator tape

Conventional transobturator tape

Arm Description

Anterior rectus fascia will be exposed and an approximately 8-10 cm × 1 cm strip of rectus fascia will be marked out. The sling will be harvested using sharp dissection. Thereafter, a Polyprolene monofilamentous mesh of 15 cm x 1 cm will be sutured to each edge of the rectus fascia sling that had been harvested. Then, a 2-cm midline incision over the anterior vaginal wall at the level of mid-urethra. A combination of blunt and sharp dissection will be carried out to the obturator foramen bilaterally. Next, a stab incision will be made at a point approximately 2.5 cm infero-lateral to the pubic tubercle bilaterally, corresponding to the level of clitoris. A trocar will be passed through each obturator foramen (outside-in) and the edge of the mesh will be retracted through the incision. Next, the retraction of both meshes will continue until the rectus fascia sling remain flushed with the urethra.

The conventional mesh using mid urethral sling through the trans obturator route

Outcomes

Primary Outcome Measures

Dryness
Absence of clinical and urodynamic stress incontinence

Secondary Outcome Measures

Full Information

First Posted
July 2, 2022
Last Updated
July 2, 2022
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05448482
Brief Title
Hybrid Versus Synthetic TOT for Treatment of SUI
Official Title
Hybrid Versus Synthetic Transobturator Tape for Treatment of Female Stress Urinary Incontinence: Prospective Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
January 5, 2023 (Anticipated)
Study Completion Date
January 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This prospective study is conducted on female patients presenting with SUI at Alexandria main university hospital. Patients with neurogenic voiding dysfunction, history of anti-incontinence surgery, urge-predominant MUI, urogenital cancer, pelvic irradiation, body mass index more than 40 kg/m2 and more than stage 1 POP are excluded. Patients are randomized into 2 groups, one group will be subjected to h_TOT, and the second group to conventional TOT. Patients are subjected to PGI and UDI-6 questionnaires and a urodynamic study before and 6 months after the both surgery. Success is defined as: no subjective complaint of SUI, negative cough stress test and no leakage on UDS.
Detailed Description
The present study will be a single center randomized clinical trial. Recruitment will be performed among women presented to Alexandria Main University Hospital urology clinic complaining of urinary stress incontinence, in whom surgery was regarded as the treatment of choice. Women will be eligible if they have a positive stress test. The stress test will be performed in a semi lithotomy position with a semi full bladder. Women will be randomized into the groups by using Sealed Opaque Envelope System. Patients will be randomized into 2 groups of 25 patient each. One group will be subjected to hybrid TOT, and the second to conventional TOT. Preoperative and post-operative (at 3 and 6 months) will include: Clinical examination including cough stress test. Patient global impression questionnaire (PGI) Patient questionnaire for incontinence (UDI-6) Urodynamic (pressure-flow study) No concomitant surgery will be performed on women enrolled in the trial. All patients will give a written informed consent. Technique of hybrid TOT The procedure will be performed while the patient is in dorsal lithotomy position under spinal saddle anesthesia. A sterile 14 Fr. Foley catheter will be placed per urethra to empty the bladder. The next step will be to harvest a strip of rectus fascia. A 4-5 cm transverse abdominal incision will be made 2 cm cephalad to the pubic symphysis. Anterior rectus fascia will be exposed and an approximately 8-10 cm × 1 cm strip of rectus fascia will be marked out. The sling will be harvested using sharp dissection and the anterior rectus fascia defect will be reapproximated using 1-0 Prolene suture. Thereafter, a Polyprolene monofilamentous mesh of 15 cm x 1 cm will be sutured to each edge of the rectus fascia sling that had been harvested. Then, normal saline will be injected in the space between the anterior vaginal wall and mid urethra for hydrodissection, followed by a 2-cm midline incision over the anterior vaginal wall at the level of mid-urethra. A combination of blunt and sharp dissection will be carried out to the obturator foramen bilaterally. Next, a stab incision will be made at a point approximately 2.5 cm infero-lateral to the pubic tubercle bilaterally, corresponding to the level of clitoris. A trocar (C-shaped, specially built for the TOT) will be passed through each obturator foramen (outside-in) and the edge of the mesh will be retracted through the incision. The same process will be repeated on the other side. Next, the retraction of both meshes will continue until the rectus fascia sling remain flushed with the urethra. An artery forceps will be kept between the fascia and the urethra to avoid excessive tension. Excess mesh on each side will be removed. The sling will be secured to the peri-urethral tissue with interrupted polyglactin 4-0 suture to prevent rolling and to ensure a flat, broad based sling. The stab incisions will be closed. The anterior vaginal wall will be closed with polyglactin 4-0 suture. Vagina will be packed with povidone iodine-soaked gauze. Vaginal pack and urethral catheter will be removed in the morning of the first postoperative day. The 2 groups will be compared using the standard statistical methods regarding outcomes and complications. The primary outcome of the study will be achievement of continence (efficacy) while the secondary outcomes will include intraoperative and early post-operative complications, convalescence, and quality of life.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hybrid transobturator tape
Arm Type
Experimental
Arm Description
Anterior rectus fascia will be exposed and an approximately 8-10 cm × 1 cm strip of rectus fascia will be marked out. The sling will be harvested using sharp dissection. Thereafter, a Polyprolene monofilamentous mesh of 15 cm x 1 cm will be sutured to each edge of the rectus fascia sling that had been harvested. Then, a 2-cm midline incision over the anterior vaginal wall at the level of mid-urethra. A combination of blunt and sharp dissection will be carried out to the obturator foramen bilaterally. Next, a stab incision will be made at a point approximately 2.5 cm infero-lateral to the pubic tubercle bilaterally, corresponding to the level of clitoris. A trocar will be passed through each obturator foramen (outside-in) and the edge of the mesh will be retracted through the incision. Next, the retraction of both meshes will continue until the rectus fascia sling remain flushed with the urethra.
Arm Title
Conventional transobturator tape
Arm Type
Active Comparator
Arm Description
The conventional mesh using mid urethral sling through the trans obturator route
Intervention Type
Procedure
Intervention Name(s)
Transobturator tape
Intervention Description
Mid urethral sling for treatment of female stress urinary incontinence
Primary Outcome Measure Information:
Title
Dryness
Description
Absence of clinical and urodynamic stress incontinence
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically proven SUI or stress-predominant mixed urinary incontinence by cough stress test. Exclusion Criteria: • Patients with neurogenic voiding dysfunction. History of anti-incontinence surgery. Presence of urge-predominant mixed urinary incontinence. Peripheral neuropathy. Multiple sclerosis. History of urogenital cancer. Pelvic irradiation Body mass index more than 40 kg/m2 The presence of more than stage 2 pelvic organ prolapse as per pelvic organ prolapse quantification (POP-Q) system score. Active urinary tract infection Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad A. Alkhawalka, MSc
Phone
01014341748
Ext
02
Email
mohammad.alkhawalka@gmail.com
Facility Information:
Facility Name
Alexandria Faculty of Medicine
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amira A. Eid, PHD
Email
amira.eid@alexmed.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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Hybrid Versus Synthetic TOT for Treatment of SUI

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