Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence

Faculdade de Medicina do ABC100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Injury Due to Sling-shot

Interventions

Transobturator slingDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Comparison of the cure rates between the mini sling and classical transobturator tapes

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

Time frame: Up to one year

Secondary Outcomes

Number of participants with adverse events

Comparison of the intra- and postoperative complications between procedures

Time frame: 0, 1, 6 and 12 months after surgery