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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: University Magna Graecia

Current Primary Outcome: Objective/subjective symptoms improvements [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Intra-operative complication rate [ Time Frame: one day ]
  • Postoperative complications rate [ Time Frame: 12 months ]
  • Failure rate [ Time Frame: 12 months ]
  • Recurrence rate [ Time Frame: 12 months ]
  • Quality of life [ Time Frame: 12 months ]
  • Sexual function [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: University Magna Graecia

Dates:
Date Received: August 28, 2008
Date Started: February 2008
Date Completion:
Last Updated: April 5, 2013
Last Verified: April 2013