Status:
COMPLETED
Tension-free Vaginal Tape (TVT) Versus Bulking Agent for the Treatment of Post Vulvectomy Urinary Incontinence
Lead Sponsor:
University Magna Graecia
Conditions:
Urinary Incontinence, Stress
Eligibility:
FEMALE
18-95 years
Phase:
PHASE3
Brief Summary
The surgical treatment of vulvar cancer is characterized by a radical approach as standard, often associated to an important rate of functional complications. This surgery often includes the partial e...
Detailed Description
Women with urinary stress incontinence developed after radical vulvectomy will be enrolled and randomized in two groups (arm 1 and arm 2). Patients of group 1 will be treated with the tension free vag...
Eligibility Criteria
Inclusion
- Stress urinary incontinence by self report, examination and test
- History of radical vulvectomy
Exclusion
- Systemic disease and/or drugs known to affect bladder function
- Current chemotherapy or radiation therapy
- Detrusor instability
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01148290
Start Date
May 1 2009
End Date
April 1 2013
Last Update
April 8 2013
Active Locations (1)
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1
Pugliese Hospital
Catanzaro, Italy, 88100