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

University Magna Graecia

Status and phase: Unknown; Phase 4

Conditions: Stress Urinary Incontinence

Treatments: Procedure: Biological transobturator tape procedure; Procedure: Autologous transobturator tape procedure; Procedure: Synthetic transobturator tape procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT00744198

02/2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

8 participants in 3 patient groups

1

Active Comparator group

Description:

Autologous sling

Treatment:

Procedure: Autologous transobturator tape procedure

2

Active Comparator group

Description:

Synthetic sling

Treatment:

Procedure: Synthetic transobturator tape procedure

3

Active Comparator group

Description:

Biological sling

Treatment:

Procedure: Biological transobturator tape procedure