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

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.

Study Overview

• Status: Terminated
• Conditions: Stress Urinary Incontinence; Cystocele
• Intervention / Treatment: Procedure: Transobturatory correction of anterior defect plus TOT; Procedure: Transobturatory correction of anterior defect plus TVT

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • "Pugliese" Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Transobturatory correction of anterior defect plus TOT	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
ACTIVE_COMPARATOR: 2; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective/subjective symptoms improvements	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life	12 months
Recurrence rate	12 months
Intra-operative complication rate	one day
Postoperative complications rate	12 months
Failure rate	12 months
Sexual function	12 months

Collaborators and Investigators

• Sponsor: University Magna Graecia

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: August 28, 2008
• First Submitted That Met QC Criteria: August 28, 2008
• First Posted (ESTIMATE): August 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 8, 2013
• Last Update Submitted That Met QC Criteria: April 5, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Treatment; Surgery; Cystocele; Mesh; TVT; TOT; Stress incontinence; Prolapse; Sling
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Prolapse; Urinary Incontinence; Urinary Incontinence, Stress; Cystocele
• Other Study ID Numbers: 03/2008