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

NCT00744198 | Unknown Phase 4

• 1 other identifier: 02/2008
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

Autologous; Biological; Mesh; Polypropylene; Sling; Synthetic; Stress incontinence; Surgery; TOT; Treatment

Outcome Measures

Primary Outcomes (1)

• Cure rate

  12 months

Secondary Outcomes (6)

• Intra-operative complication rate

  one day

• Postoperative complications rate

  12 months

• Failure rate

  12 months

• Recurrence rate

  12 months

• Quality of life

  12 months

Study Arms (3)

1

ACTIVE COMPARATOR

Autologous sling

Procedure: Autologous transobturator tape procedure

2

ACTIVE COMPARATOR

Synthetic sling

Procedure: Synthetic transobturator tape procedure

3

ACTIVE COMPARATOR

Biological sling

Procedure: Biological transobturator tape procedure

Interventions

Autologous transobturator tape procedure 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

1

Synthetic transobturator tape procedure 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.

2

Biological transobturator tape procedure 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

3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Genuine stress urinary incontinence by self report, examination and test
• Urethral hypermobility
• Eligible for all three surgical procedures
• Ambulatory

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

"Pugliese" Hospital

Catanzaro, Catanzaro, 88100, Italy

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Palomba, MD

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

  PRINCIPAL INVESTIGATOR

• Fulvio Zullo, MD

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

  STUDY CHAIR

Central Study Contacts

Stefano Palomba, MD

CONTACT

stefanopalomba@tin.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 29, 2008
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

IT (1)