Stress Urinary Incontinence
Conditions
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.
Interventions
PROCEDUREtransobturator tape
Women with stress urinary incontinence are treated by transobturator tape versus mini sling
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding incidence of complications | one year | comparing between mini sling and transobturator tape in surgical management of women with stress urinary incontinence regarding: • Urinary continence measured by ICIQ(international continence index questionnaire) |
| Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding postoperative pain | one year | comparing between mini sling and transobturator tape in surgical management of women with stress urinary incontinence regarding: • Post operative pain measured by NRS(numerical rating pain score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding sexual function | one year | comparing between mini sling and transobturator tape in surgical management of women with stress urinary incontinence regarding: • Sexual function measured by FSFI(female sexual function index) |
Contacts
Primary ContactTarek Salem
Backup ContactAhmed Emam
Outcome results
None listed