NCT00743535

Anterior Defect Correction With Mesh Plus Treatment of Stress Incontinence With Transobturator or Transvaginal Approach

A Comparison in Terms of Efficacy and Safety Between Transobturator and Transvaginal Tape Performed at the Same Time of Anterior Defect Correction With Mesh

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University Magna Graecia · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The incidence of anterior pelvic defect in women is estimated about 10% and it may be often associated to urinary stress incontinence. To date the correction of anterior defects with the use of graft material inserted with transobturator approach has become of large use. Moreover, given the frequent association of urinary stress incontinence to anterior defect, in most of cases it becomes necessary to perform at the same time an anti-incontinence procedure, i.e. a sub-urethral sling positioning. Based on these considerations the aim of this trial will be to compare two different approach for sub-urethral sling positioning, transobturator and transvaginal tape (TOT and TVT) performed in association to transobturator correction of anterior defect with mesh in terms of efficacy and safety.

Detailed description

Women with anterior defect and genuine stress urinary incontinence will be enrolled and randomized in two groups (arm 1 and 2). All patients will be treated with a transobturator correction of anterior defect, in patients of arm 1 will be associated TOT, whereas in patients of arm 2 will be associated TVT. All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, urodynamic, and ultrasonographic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient. Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.

Conditions

• Cystocele
• Stress Urinary Incontinence

Interventions

Type	Name	Description
PROCEDURE	Transobturatory correction of anterior defect plus TOT	Longitudinal vaginal incision 1 cm far from esternal urethral meatus. Bladder dissecting and identification of ischiatic spines. Bilateral transobturator insertion of anterior mesh through high and low trans-obturatory approach. Mesh anchorage. Small incision sites in the femoral/pelvic fold. Bilateral transobturator insertion of mesh by means of mono-use needle
PROCEDURE	Transobturatory correction of anterior defect plus TVT	Longitudinal vaginal incision 1 cm far from esternal urethral meatus. Bladder dissecting and identification of ischiatic spines. Bilateral transobturator insertion of anterior mesh through high and low trans-obturatory approach. Mesh anchorage. Small incision sites at sovrapubic level. Bilateral retropubic insertion of mesh by means of mono-use needle.

Timeline

• Start date: 2008-02-01
• Primary completion: 2013-02-01
• First posted: 2008-08-29
• Last updated: 2013-04-08

Locations

1 site across 1 country: Italy