Clinical trial NCT06334848: Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence
Official title: Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 42
Sex: FEMALE
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding incidence of complications
timeFrame: one year
measure: Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding postoperative pain
timeFrame: one year
Secondary outcomes:
measure: Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding sexual function
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
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