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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00744198
• Other study ID #: 02/2008
• Status: Recruiting
• Phase: Phase 4
• First received: August 26, 2008
• Last updated: April 5, 2013
• Start date: August 2012

Study information

• Verified date: April 2013
• Source: University Magna Graecia
• Contact: Stefano Palomba, MD
• Email: stefanopalomba[@]tin.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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
• 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.
• 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

Locations

Country	Name	City	State
Italy	"Pugliese" Hospital	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate		12 months	No
Secondary	Intra-operative complication rate		one day	Yes
Secondary	Postoperative complications rate		12 months	Yes
Secondary	Failure rate		12 months	No
Secondary	Recurrence rate		12 months	No
Secondary	Quality of life		12 months	No
Secondary	Sexual function		12 months	No