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

Primary Purpose

Cystocele, Stress Urinary Incontinence

Status

Terminated

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Transobturatory correction of anterior defect plus TOT

Transobturatory correction of anterior defect plus TVT

About this trial

This is an interventional treatment trial for Cystocele focused on measuring Cystocele, Mesh, Prolapse, Sling, Stress incontinence, Surgery, TOT, TVT, Treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

"Pugliese" Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

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 at sovrapubic level. Bilateral retropubic insertion of mesh by means of mono-use needle.

Outcomes

Primary Outcome Measures

Objective/subjective symptoms improvements

Secondary Outcome Measures

Intra-operative complication rate

Postoperative complications rate

Failure rate

Recurrence rate

Quality of life

Sexual function

Full Information

NCT ID

NCT00743535

First Posted

August 28, 2008

Last Updated

April 5, 2013

Sponsor

University Magna Graecia

1. Study Identification

Unique Protocol Identification Number

NCT00743535

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Terminated

Why Stopped

Low recruitment rate.

Study Start Date

February 2008 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Magna Graecia

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystocele, Stress Urinary Incontinence

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Transobturatory correction of anterior defect plus TOT

Arm Title

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Transobturatory correction of anterior defect plus TOT

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Transobturatory correction of anterior defect plus TVT

Intervention Description

Primary Outcome Measure Information:

Title

Objective/subjective symptoms improvements

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Intra-operative complication rate

Time Frame

one day

Title

Postoperative complications rate

Time Frame

12 months

Title

Failure rate

Time Frame

12 months

Title

Recurrence rate

Time Frame

12 months

Title

Quality of life

Time Frame

12 months

Title

Sexual function

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefano Palomba, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fulvio Zullo, MD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

"Pugliese" Hospital

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

12. IPD Sharing Statement

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

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