Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence

Ain Shams University

Status: Not yet enrolling

Conditions: Stress Urinary Incontinence

Treatments: Procedure: transobturator tape

Study type: Interventional

Funder types: Other

Identifiers

NCT06334848

TOT versus mini sling

Details and patient eligibility

About

To compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence.

Full description

Urinary incontinence is defined as involuntary loss of urine and is divided into subtypes according to symptoms. These subtypes include SUI, in which urine loss occurs during exertion, physical exercise, coughing or sneezing; urgency urinary incontinence (UUI), in which urine loss is associated with urinary urgency; and mixed urinary incontinence (MUI), which is characterized by the association of stress loss with urgency.

There are non-surgical treatments (e.g., lifestyle modifications, pharmacotherapy, physiotherapy and vaginal pessary) and surgical treatments.

As regards sling use, it was found that mid urethral slings techniques achieved high cure rates in women with SUI and have become the mainstay for surgical treatment of SUI in women over the last 2 decades.

One of the modalities of such procedures is the transobturator mid urethral tape (TOT). It was introduced to minimize the complications of the previous retropubic tapes, which include injury to the bladder, major vessels, and bowel.

In an effort to maintain efficacy while eliminating some of the side effects, a new generation of tapes has been developed, called single incision tapes or mini-slings. They are designed to be shorter in length than standard mid-urethral slings and do not penetrate the tissues as deeply as standard slings.

Enrollment: 42 estimated patients

Sex: Female

Ages: Under 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women with a medical history of SUI
• mixed urinary incontinence (MUI) in which SUI had to be the dominating symptom
• confirmed by a positive standardized cough test with 300 cm3 water in the bladder

Exclusion criteria

• Women will be excluded if they are aged >60 years
• had previous incontinence or pelvic organ prolapse surgery
• planned or present pregnancy
• residual urine volume>100 ml
• previous pelvic irradiation
• neurological conditions such as multiple sclerosis
• current treatment with corticoids
• history of genital or abdominal cancer or a pelvic mass.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

treatment of stress urinary incontinence by transobturator tape

Other group

Description:

patients with stress urinary incontinence are treated by transobturator tape

Treatment:

Procedure: transobturator tape

treatment of stress urinary incontinence by mini sling

Other group

Description:

patients with stress urinary incontinence are treated by mini sling

Treatment:

Procedure: transobturator tape