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

Sponsor

University Magna Graecia (Other)

Overall Status

Terminated

CT.gov ID

NCT00743535

Collaborator

(none)

Enrollment

Location

Arms

Study Details

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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Objective/subjective symptoms improvements [12 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	"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