Injury Due to Sling-shot
Conditions
Keywords
stress incontinence, transobturator sling, single-incision mini-sling
Brief summary
1. OBJECTIVE: To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence (SUI) treatment. 2. METHODS: This prospective single-center randomized controlled trial will involve 100 women with a diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form, operation time, complications, and reoperation rates were also recorded. The efficacy was analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P value \>.05 rejects the noninferiority hypothesis of the mini-sling.
Interventions
DEVICEOphira
The procedure will be perfomed with a single incision in anterior wall vagina
DEVICETransobturator sling
Safyre T Plus ® system uses two helical needles for securing an average urethral sling mesh polypropylene soft tissue below the pubic bone by means of spinal anesthesia. Short form of the sling implantation is carried out as follows: a small longitudinal incision in the anterior vaginal wall approximately 2 cm is performed at 1 cm from the urethral meatus. Takes place below minimum dissection toward the lower branch of the ischium, and with the aid of the needle obturator and perforated membrane (outside-in maneuver). After that, the sling is attached to the needle carrying the same path. Subsequently, the passage of the needle is held in contraleral side. The procedure finishes performing the adjustment of the track with the aid of Kelly forceps type.
Sponsors
Faculdade de Medicina do ABC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged over 18 years * Clinical and urodynamic diagnosis of stress urinary incontinence * Absence of associated neurological diseases * No clinically significant detrusor instability (ie, to determine which symptoms are proportionally more significant for patient incontinence efforts)
Exclusion criteria
* urodynamic changes suggesting a reduction in bladder capacity, bladder compliance or suggestive of bladder outlet obstruction * Coagulopathies * Pregnancy * History of sensitivity to foreign body * Acute Urinary Tract Infection * Sequelae of high exposure to ionizing radiation * Use of drugs that can result in high and / or risk of significant postoperative complications surgical risk, including any drug that interferes with blood clotting * anesthetic contraindication to the procedure * Vulvovaginitis: presence of vaginal discharge with laboratory proven infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the cure rates between the mini sling and classical transobturator tapes | Up to one year | Percentage of patients who are regarded as cured or improved based on the following criteria: * Negative Cough Stress test 1 year after surgery * Pad Test \< 2 g 1 year after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | 0, 1, 6 and 12 months after surgery | Comparison of the intra- and postoperative complications between procedures |
Countries
Brazil
Outcome results
None listed