Autologous Versus Synthetic Versus Biological Sling for Trans-obturator Correction of Urinary Stress Incontinence
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00744198 |
Recruitment Status
: Unknown
Verified April 2013 by Stefano Palomba, University Magna Graecia.
Recruitment status was: Recruiting
First Posted
: August 29, 2008
Last Update Posted
: April 8, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 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 |

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
|
- Cure rate [ Time Frame: 12 months ]
- Intra-operative complication rate [ Time Frame: one day ]
- Postoperative complications rate [ Time Frame: 12 months ]
- Failure rate [ Time Frame: 12 months ]
- Recurrence rate [ Time Frame: 12 months ]
- Quality of life [ Time Frame: 12 months ]
- Sexual function [ Time Frame: 12 months ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744198
Contact: Stefano Palomba, MD | stefanopalomba@tin.it |
Italy | |
"Pugliese" Hospital | Recruiting |
Catanzaro, Italy, 88100 | |
Contact: Ingrid Tomaino, MD 39-096-188-3234 angela.falbo@libero.it | |
Principal Investigator: Stefano Palomba, MD |
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 |
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 Key Record Dates |
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 |