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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Magna Graecia
Sponsor:
Information provided by (Responsible Party):
Stefano Palomba, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00744198
First received: August 26, 2008
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Stress Urinary Incontinence
Procedure: Autologous transobturator tape procedure
Procedure: Synthetic transobturator tape procedure
Procedure: Biological transobturator tape procedure
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison in Terms of Efficacy and Safety Among Three Different Materials for Trans-obturator Correction of Urinary Stress Incontinence: Autologous, Synthetic and Biological Sling

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Cure rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intra-operative complication rate [ Time Frame: one day ] [ Designated as safety issue: Yes ]
  • Postoperative complications rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Failure rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Recurrence rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Sexual function [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: August 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Autologous sling
Procedure: 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
Active Comparator: 2
Synthetic sling
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.
Active Comparator: 3
Biological sling
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744198

Contacts
Contact: Stefano Palomba, MD stefanopalomba@tin.it

Locations
Italy
"Pugliese" Hospital Recruiting
Catanzaro, Italy, 88100
Contact: Ingrid Tomaino, MD    39-096-188-3234    angela.falbo@libero.it   
Principal Investigator: Stefano Palomba, MD         
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
  More Information

No publications provided

Responsible Party: Stefano Palomba, Associate Professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT00744198     History of Changes
Other Study ID Numbers: 02/2008
Study First Received: August 26, 2008
Last Updated: April 5, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University Magna Graecia:
Autologous
Biological
Mesh
Polypropylene
Sling
Synthetic
Stress incontinence
Surgery
TOT
Treatment

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014