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

University Magna Graecia

Status and phase: Terminated; Phase 4

Conditions: Stress Urinary Incontinence; Cystocele

Treatments: Procedure: Transobturatory correction of anterior defect plus TOT; Procedure: Transobturatory correction of anterior defect plus TVT

Study type: Interventional

Funder types: Other

Identifiers

NCT00743535

03/2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cystocele
• Genuine stress urinary incontinence by self report, examination and test
• Urethral hypermobility
• Eligible for both surgical procedures
• Ambulatory

Exclusion criteria

• Pregnancy
• <12 months post-partum
• Systemic disease and/or drugs known to affect bladder function
• Current chemotherapy or radiation therapy
• Urethral diverticulum, augmentation cytoplasty, or artificial sphincter
• Recent pelvic surgery
• Previous pelvic or anti-incontinence surgery
• History of severe abdominopelvic infections
• Known extensive abdominopelvic adhesions
• Detrusor instability and/or intrinsic sphincter dysfunction
• Other gynaecologic pathologies (eg, fibroids, ovarian cysts)
• BMI >30

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

1

Experimental group

Description:

Transobturatory correction of anterior defect plus TOT

Treatment:

Procedure: Transobturatory correction of anterior defect plus TOT

2

Active Comparator group

Description:

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.

Treatment:

Procedure: Transobturatory correction of anterior defect plus TVT