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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00743535
• Other study ID #: 03/2008
• Status: Terminated
• Phase: Phase 4
• First received: August 28, 2008
• Last updated: April 5, 2013
• Start date: February 2008

Study information

• Verified date: April 2013
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystocele
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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
• 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.

Locations

Country	Name	City	State
Italy	"Pugliese" Hospital	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective/subjective symptoms improvements		12 months	No
Secondary	Intra-operative complication rate		one day	Yes
Secondary	Postoperative complications rate		12 months	Yes
Secondary	Failure rate		12 months	No
Secondary	Recurrence rate		12 months	No
Secondary	Quality of life		12 months	No
Secondary	Sexual function		12 months	No