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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

August 28, 2008
April 5, 2013
February 2008
February 2013   (final data collection date for primary outcome measure)
Objective/subjective symptoms improvements [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00743535 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cystocele
  • Stress Urinary Incontinence
  • 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.
  • Experimental: 1
    Transobturatory correction of anterior defect plus TOT
    Intervention: Procedure: Transobturatory correction of anterior defect plus TOT
  • 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.

    Intervention: Procedure: Transobturatory correction of anterior defect plus TVT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
Not Provided
February 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00743535
03/2008
Not Provided
Stefano Palomba, University Magna Graecia
University Magna Graecia
Not Provided
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
University Magna Graecia
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP