Hybrid Versus Synthetic TOT for Treatment of SUI

NCT05448482 | Unknown

• 1 other identifier: Serial No : 0202538
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Stress Incontinence

Outcome Measures

Primary Outcomes (1)

• Dryness

  Absence of clinical and urodynamic stress incontinence

  6 months

Study Arms (2)

Hybrid transobturator tape

EXPERIMENTAL

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.

Procedure: Transobturator tape

Conventional transobturator tape

ACTIVE COMPARATOR

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

Procedure: Transobturator tape

Interventions

Transobturator tape PROCEDURE

Mid urethral sling for treatment of female stress urinary incontinence

Conventional transobturator tape; Hybrid transobturator tape

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, Egypt

RECRUITING

MeSH Terms

Interventions

Suburethral Slings

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Mohammad A. Alkhawalka, MSc

CONTACT

01014341748; mohammad.alkhawalka@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2022
• First Posted: July 7, 2022
• Study Start: January 5, 2021
• Primary Completion: January 5, 2023
• Study Completion: January 15, 2023
• Last Updated: July 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)