Status:
UNKNOWN
Autologous Versus Synthetic Versus Biological Sling for Trans-obturator Correction of Urinary Stress Incontinence
Lead Sponsor:
University Magna Graecia
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18-80 years
Phase:
PHASE4
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 i...
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...
Eligibility Criteria
Inclusion
- Genuine stress urinary incontinence by self report, examination and test
- Urethral hypermobility
- Eligible for all three surgical procedures
- Ambulatory
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00744198
Start Date
August 1 2012
Last Update
April 8 2013
Active Locations (1)
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1
"Pugliese" Hospital
Catanzaro, Catanzaro, Italy, 88100