Back to resultsTension-free Vaginal Tape (TVT) Versus Bulking Agent for the Treatment of Post Vulvectomy Urinary Incontinence
Primary Purpose
Urinary Incontinence, Stress
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Tension free vaginal tape
Bulking agent injection
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Stress focused on measuring bulking agent, emivulvectomy, radical vulvectomy, TVT, urinary incontinence, vulvar cancer
Eligibility Criteria
Inclusion Criteria:
- Stress urinary incontinence by self report, examination and test
- History of radical vulvectomy
Exclusion Criteria:
- Systemic disease and/or drugs known to affect bladder function
- Current chemotherapy or radiation therapy
- Detrusor instability
Sites / Locations
- Pugliese Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Tension free vaginal tape
Bulking agent injection
Arm Description
Outcomes
Primary Outcome Measures
Cure rate
Secondary Outcome Measures
Intra-operative complication rate
Postoperative complication rate
Recurrence rate
Second surgery for stress urinary incontinence (SUI)
Quality of life
Satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01148290
Brief Title
Tension-free Vaginal Tape (TVT) Versus Bulking Agent for the Treatment of Post Vulvectomy Urinary Incontinence
Official Title
A Comparison Between Tension-free Vaginal Tape and Bulking Agent for the Treatment of Post-vulvectomy Urinary Incontinence: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Magna Graecia
4. Oversight
5. Study Description
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 excision of urethra, resulting in a reduction of urethral closure pressure. The radiotherapy-induced fibrosis in addiction leads to a reduction of urethral mobility. As consequence women treated for vulvar cancer may develop urinary incontinence. The incidence of this complication has been differently reported, but seems to reach the 100%. Poor data are available regarding the treatment of post vulvectomy urinary incontinence and no clear indication may be given at regards.
Based on these considerations the aim of this trial will be to compare tension free vaginal tape and bulking agent injection in women with urinary stress incontinence developed after radical surgery for vulvar cancer.
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 vaginal tape, whereas in patients of arm 2 will be used the bulking agent injection.
All eligible patients will undergo baseline assessment consisting of anthropometric, clinical, and urodynamic 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
Keywords
bulking agent, emivulvectomy, radical vulvectomy, TVT, urinary incontinence, vulvar cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tension free vaginal tape
Arm Type
Active Comparator
Arm Title
Bulking agent injection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Tension free vaginal tape
Intervention Description
Small incision sites in the vagina and suprapubically. Bilateral retropubic insertion of the sling by means of needles
Intervention Type
Procedure
Intervention Name(s)
Bulking agent injection
Intervention Description
Three Periurethral injections of Bulkamid ® (Ethicon,Somerville, NJ, USA)
Primary Outcome Measure Information:
Title
Cure rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Intra-operative complication rate
Time Frame
1 day
Title
Postoperative complication rate
Time Frame
12 months
Title
Recurrence rate
Time Frame
12 months
Title
Second surgery for stress urinary incontinence (SUI)
Time Frame
12 months
Title
Quality of life
Time Frame
12 months
Title
Satisfaction
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stress urinary incontinence by self report, examination and test
History of radical vulvectomy
Exclusion Criteria:
Systemic disease and/or drugs known to affect bladder function
Current chemotherapy or radiation therapy
Detrusor instability
Facility Information:
Facility Name
Pugliese Hospital
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Tension-free Vaginal Tape (TVT) Versus Bulking Agent for the Treatment of Post Vulvectomy Urinary Incontinence
We'll reach out to this number within 24 hrs