Status:
COMPLETED
A Randomized Controlled Study Comparing Three Single-incision Devices for Female Urinary Stress Incontinence
Lead Sponsor:
University Magna Graecia
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18-80 years
Phase:
PHASE4
Brief Summary
The prevalence of urinary stress incontinence in middle age women is rated at about 30%. To date, there is an increasing use in the clinical practice of new techniques for the treatment of this condit...
Detailed Description
Women with genuine urinary stress incontinence not associated with POP will be enrolled and randomized in three groups (arm 1, arm 2 and arm 3). All patients eligible will undergo baseline assessment ...
Eligibility Criteria
Inclusion
- genuine stress incontinence
Exclusion
- pregnancy
- \<12 months postpartum
- systemic disease and/or drugs known to affect bladder function
- current chemotherapy or radiation therapy
- urethral diverticulum
- augmentation cytoplasty
- artificial sphincter
- genital prolapse equal to or more than second degree
- history of severe abdominopelvic infections
- detrusor instability and/or intrinsic sphincter dysfunction
- other gynecologic pathologies
- BMI \>30
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00751088
Start Date
September 1 2008
Last Update
February 27 2013
Active Locations (1)
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1
"Pugliese" Hospital
Catanzaro, Catanzaro, Italy, 88100