Tension-free Vaginal Tape (TVT) Versus Bulking Agent for the Treatment of Post Vulvectomy Urinary Incontinence
A Comparison Between Tension-free Vaginal Tape and Bulking Agent for the Treatment of Post-vulvectomy Urinary Incontinence: a Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 21, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedApril 8, 2013
April 1, 2013
3.3 years
June 21, 2010
April 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cure rate
12 months
Secondary Outcomes (6)
Intra-operative complication rate
1 day
Postoperative complication rate
12 months
Recurrence rate
12 months
Second surgery for stress urinary incontinence (SUI)
12 months
Quality of life
12 months
- +1 more secondary outcomes
Study Arms (2)
Tension free vaginal tape
ACTIVE COMPARATORBulking agent injection
EXPERIMENTALInterventions
Small incision sites in the vagina and suprapubically. Bilateral retropubic insertion of the sling by means of needles
Three Periurethral injections of Bulkamid ® (Ethicon,Somerville, NJ, USA)
Eligibility Criteria
You may qualify if:
- Stress urinary incontinence by self report, examination and test
- History of radical vulvectomy
You may not qualify if:
- Systemic disease and/or drugs known to affect bladder function
- Current chemotherapy or radiation therapy
- Detrusor instability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pugliese Hospital
Catanzaro, 88100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 21, 2010
First Posted
June 22, 2010
Study Start
May 1, 2009
Primary Completion
September 1, 2012
Study Completion
April 1, 2013
Last Updated
April 8, 2013
Record last verified: 2013-04