Autologous Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal

sarah mohamed hassan

Status and phase: Unknown; Phase 3

Conditions: Stress Urinary Incontinence

Treatments: Procedure: TVT-O; Procedure: Hybrid sling

Study type: Interventional

Funder types: Other

Identifiers

NCT03473041

783

Details and patient eligibility

About

a hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) versus transobturator tension free vaginal tape(TVT-O)

Full description

a surgeon tailored hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) is used for treatment of urinary stree incontinence and its efficacy is compared to transobturator tension free vaginal tape (TVT-O) conventional mid urethral sling

Enrollment: 140 estimated patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stress urinary incontinence

Exclusion criteria

• previous surgery for stress incontinence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Hybrid sling

Active Comparator group

Description:

70 patients with stress urinary incontinence treated with surgeon tailored hybrid sling

Treatment:

Procedure: Hybrid sling

TVT-O

Active Comparator group

Description:

70 patients with stress urinary incontinence treated with conventional TVT-O

Treatment:

Procedure: TVT-O