Status:
TERMINATED
Anterior Defect Correction With Mesh Plus Treatment of Stress Incontinence With Transobturator or Transvaginal Approach
Lead Sponsor:
University Magna Graecia
Conditions:
Cystocele
Stress Urinary Incontinence
Eligibility:
FEMALE
18-80 years
Phase:
PHASE4
Brief Summary
The incidence of anterior pelvic defect in women is estimated about 10% and it may be often associated to urinary stress incontinence. To date the correction of anterior defects with the use of graft ...
Detailed Description
Women with anterior defect and genuine stress urinary incontinence will be enrolled and randomized in two groups (arm 1 and 2). All patients will be treated with a transobturator correction of anterio...
Eligibility Criteria
Inclusion
- Cystocele
- Genuine stress urinary incontinence by self report, examination and test
- Urethral hypermobility
- Eligible for both 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
- 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 :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00743535
Start Date
February 1 2008
Last Update
April 8 2013
Active Locations (1)
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1
"Pugliese" Hospital
Catanzaro, Catanzaro, Italy, 88100