Female Stress Urinary Incontinence
Conditions
Keywords
Urodynamic Stress urinary incontinence, Minisling, Ophira™, Unitape™
Brief summary
A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot with minisling.
Detailed description
eligibility criteria was : female stress urinary incontinence
Interventions
PROCEDUREMini-sling
The minisling is a new intervention therapeutic option for surgical treatment in women with stress urinary incontinence. It is made of polypropylene monofilament mesh, held between two self-anchoring polypropylene columns in a fishbone design connected to two delivering needles.
PROCEDURETransobturator
Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The participants were randomly allocated to a single-incision mini-sling or a transobturator midurethral tape by a simple randomization procedure using a random number generator computer program. Randomization was performed at the moment of inclusion by a nurse blinded to women's histories. Group assign- ment was concealed in consecutively numbered, sealed, opaque envelopes that were opened in the operating room just before the procedure.
Intervention model description
Clinical, prospective, single-center, randomized controlled trial comparing the efficacy and safety of a single-incision mini-sling and a transobturator midurethral sling for female stress urinary incontinence (SUI) treatment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* clinical and urodynamic diagnosis of SUI in patients between 18 and 90 years
Exclusion criteria
* postvoid residual urine volume more than 100 ml, coagulation disorders, current urinary tract infection, sequelae of previous radiation therapy of the pelvis, anticoagulant therapy, vulvovaginitis, and anesthesia contraindication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| to assess efficacy between tot with minisling in cure in women with stress urinary incontinence | one year | to assess efficacy and safety of minisling and transobturator sling in treatment of female stress urinary incontinence |
Countries
Brazil
Outcome results
None listed