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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Stress Urinary Incontinence	Procedure: Autologous transobturator tape procedure; Procedure: Synthetic transobturator tape procedure; Procedure: Biological transobturator tape procedure	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	8 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	August 2012
Estimated Primary Completion Date :	August 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Cure rate [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. Intra-operative complication rate [ Time Frame: one day ]
2. Postoperative complications rate [ Time Frame: 12 months ]
3. Failure rate [ Time Frame: 12 months ]
4. Recurrence rate [ Time Frame: 12 months ]
5. Quality of life [ Time Frame: 12 months ]
6. Sexual function [ Time Frame: 12 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Stefano Palomba, Associate Professor, University Magna Graecia
ClinicalTrials.gov Identifier:	NCT00744198 History of Changes
Other Study ID Numbers:	02/2008
First Posted:	August 29, 2008
Last Update Posted:	April 8, 2013
Last Verified:	April 2013

Keywords provided by Stefano Palomba, University Magna Graecia:

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

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms	Urological Manifestations; Signs and Symptoms; Behavioral Symptoms; Elimination Disorders; Mental Disorders