Transobturator Verus Single Incision Slings

Cecilia Calvo

Status: Completed

Conditions: Urinary Incontinence, Stress

Treatments: Device: Mini-arc; Device: Monarc

Study type: Interventional

Funder types: Other

Identifiers

NCT02599051

IRB 9034

Details and patient eligibility

About

A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling

Full description

Transobturator slings are one type of sling that has become standard treatment for stress urinary incontinence. However, this procedure involves a total of 3 incisions to perform.

In contrast, single incision slings have been developed to treat stress urinary incontinence by using only one incision.

However, to date the success and complications of these two procedures have not been compared or studied.

Enrollment: 98 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment.

Exclusion criteria

• Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Monarc

Active Comparator group

Description:

Placement of a transobturator monarc sling for stress urinary incontinence

Treatment:

Device: Monarc

Mini-arc

Experimental group

Description:

Placement of a single incision mini-arc sling for stress urinary incontinence

Treatment:

Device: Mini-arc