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

This study has been terminated.
(Low recruitment rate.)
Sponsor:
Information provided by (Responsible Party):
Stefano Palomba, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00743535
First received: August 28, 2008
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Cystocele
Stress Urinary Incontinence
 Procedure: Transobturatory correction of anterior defect plus TOT
Procedure: Transobturatory correction of anterior defect plus TVT
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison in Terms of Efficacy and Safety Between Transobturator and Transvaginal Tape Performed at the Same Time of Anterior Defect Correction With Mesh

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Objective/subjective symptoms improvements [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intra-operative complication rate [ Time Frame: one day ] [ Designated as safety issue: Yes ]
  • Postoperative complications rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Failure rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Recurrence rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Sexual function [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: February 2008
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743535

Locations
Italy
"Pugliese" Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
Principal Investigator: Stefano Palomba, MD Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Study Chair: Fulvio Zullo, MD Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
  More Information

No publications provided

Responsible Party: Stefano Palomba, Associate Professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT00743535     History of Changes
Other Study ID Numbers: 03/2008
Study First Received: August 28, 2008
Last Updated: April 5, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University Magna Graecia:
Cystocele
Mesh
Prolapse
Sling
Stress incontinence
 Surgery
TOT
TVT
Treatment

Additional relevant MeSH terms:
Cystocele
Urinary Incontinence
Urinary Incontinence, Stress
Urinary Bladder Diseases
Urologic Diseases
Pelvic Organ Prolapse
 Prolapse
Pathological Conditions, Anatomical
Urination Disorders
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013