A Comparative Study Minisling Versus Transobturator (TOT)Sling (sui)

Federal University of São Paulo

Status and phase: Completed; Phase 4

Conditions: Female Stress Urinary Incontinence

Treatments: Procedure: Mini-sling; Procedure: Transobturator

Study type: Interventional

Funder types: Other

Identifiers

NCT01094353

ophira

Details and patient eligibility

About

A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot with minisling.

Full description

eligibility criteria was : female stress urinary incontinence

Enrollment: 145 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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145 participants in 2 patient groups

Mini-sling

Active Comparator group

Description:

The minisling Ophira™ 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.

Treatment:

Procedure: Mini-sling

Transobturator

Active Comparator group

Description:

Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence

Treatment:

Procedure: Transobturator