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

NCT00743535 | Terminated Phase 4

• 1 other identifier: 03/2008
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystocele; Stress Urinary Incontinence

Keywords

Cystocele; Mesh; Prolapse; Sling; Stress incontinence; Surgery; TOT; TVT; Treatment

Outcome Measures

Primary Outcomes (1)

• Objective/subjective symptoms improvements

  12 months

Secondary Outcomes (6)

• Intra-operative complication rate

  one day

• Postoperative complications rate

  12 months

• Failure rate

  12 months

• Recurrence rate

  12 months

• Quality of life

  12 months

Study Arms (2)

1

EXPERIMENTAL

Transobturatory correction of anterior defect plus TOT

Procedure: Transobturatory correction of anterior defect plus TOT

2

ACTIVE COMPARATOR

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

Interventions

Transobturatory correction of anterior defect plus TOT PROCEDURE

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

1

Transobturatory correction of anterior defect plus TVT PROCEDURE

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.

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

"Pugliese" Hospital

Catanzaro, Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Cystocele; Urinary Incontinence, Stress; Prolapse

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pelvic Organ Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• Stefano Palomba, MD

  Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

  PRINCIPAL INVESTIGATOR

• Fulvio Zullo, MD

  Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2013
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

IT (1)