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

ABC Foundation (FUABC)

Status: Completed

Conditions: Injury Due to Sling-shot

Treatments: Device: Transobturator sling; Device: Ophira

Study type: Interventional

Funder types: Other

Identifiers

NCT02540525

URO-2009

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Single incision mini-sling

Experimental group

Description:

Experimental group: surgery to treat stress urinary incontinence with the Ophira mini sling systemt®

Treatment:

Device: Ophira

Transobturator sling

Active Comparator group

Description:

Control group: surgery to treat stress urinary incontinence with the Unitape T Plus®.

Treatment:

Device: Transobturator sling