Autologous Versus Synthetic Versus Biological Sling for Trans-obturator Correction of Urinary Stress Incontinence

NCT ID: NCT00744198

Last Updated: 2013-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31

Brief Summary

The treatment of urinary stress incontinence with trans-obturator approach, know as transobturatory tape (TOT), is a largely used sling-adopting procedures. The efficacy and safety of this minimally invasive surgery have been demonstrated, also in comparison with similar procedures, i.e transvaginal tape (TVT).

To date the results of TOT in terms of efficacy and safety described in literature mainly refer to procedure in which synthetic materials are used, whereas few data regarding the use of biological materials are available. Moreover, despite the well known benefits of the available synthetic and eterologue kit, their use may be limited by the high cost of these materials. At this proposal it can be suggested as alternative option the possibility to perform the procedure using an autologous tissue, i.e. rectus fascia, and reusable introductory needles. Based on these considerations the aim of this trial will be to compare autologous, synthetic and biological mesh for TOT in women with urinary stress incontinence.

Detailed Description

Women with genuine stress urinary incontinence will be enrolled and randomized in three groups (arm 1, arm 2, arm 3). All patients will be treated with a transobturatory approach, in patients of arm 1 will be used an autologous tissue and reusable introductory needles, in patients of arm 2 will be used a synthetic kit whereas in arm 3 will be a biological kit .

All eligible patients 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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Autologous sling

Group Type: ACTIVE_COMPARATOR

Autologous transobturator tape procedure

Intervention Type: PROCEDURE

A strip of rectus fascia is harvested. Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of the autologous strip by means of reusable needles

2

Synthetic sling

Group Type: ACTIVE_COMPARATOR

Synthetic transobturator tape procedure

Intervention Type: PROCEDURE

Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of synthetic mesh by means of mono-use needles.

3

Biological sling

Group Type: ACTIVE_COMPARATOR

Biological transobturator tape procedure

Intervention Type: PROCEDURE

Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of biological mesh by means of mono-use needle

Interventions

Autologous transobturator tape procedure

A strip of rectus fascia is harvested. Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of the autologous strip by means of reusable needles

Intervention Type: PROCEDURE

Synthetic transobturator tape procedure

Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of synthetic mesh by means of mono-use needles.

Intervention Type: PROCEDURE

Biological transobturator tape procedure

Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of biological mesh by means of mono-use needle

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Genuine stress urinary incontinence by self report, examination and test
• Urethral hypermobility
• Eligible for all three 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
• Severe genuine stress incontinence (loss of urine with minimal physical activity) with associated prolapse equal to or more than second degree
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Stefano Palomba

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Palomba, MD

Role: PRINCIPAL_INVESTIGATOR

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

Fulvio Zullo, MD

Role: STUDY_CHAIR

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

Locations

"Pugliese" Hospital

Catanzaro, Catanzaro, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefano Palomba, MD

Role: CONTACT

stefanopalomba@tin.it

Facility Contacts

Ingrid Tomaino, MD

Role: primary

angela.falbo@libero.it

39-096-188-3234

Other Identifiers

02/2008

Identifier Type: -

Identifier Source: org_study_id