Hybrid Versus Synthetic TOT for Treatment of SUI

NCT ID: NCT05448482

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-05
• Study Completion Date: 2023-01-15

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.

Conditions

Female Stress Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Hybrid transobturator tape

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.

Group Type: EXPERIMENTAL

Transobturator tape

Intervention Type: PROCEDURE

Mid urethral sling for treatment of female stress urinary incontinence

Conventional transobturator tape

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

Group Type: ACTIVE_COMPARATOR

Transobturator tape

Intervention Type: PROCEDURE

Mid urethral sling for treatment of female stress urinary incontinence

Interventions

Transobturator tape

Mid urethral sling for treatment of female stress urinary incontinence

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alexandria Faculty of Medicine

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohammad A. Alkhawalka, MSc

Role: CONTACT

mohammad.alkhawalka@gmail.com

01014341748 ext. 02

Facility Contacts

Amira A. Eid, PHD

Role: primary

amira.eid@alexmed.edu.eg

Other Identifiers

Serial No : 0202538

Identifier Type: -

Identifier Source: org_study_id