Tension-free Vaginal Tape (TVT) Versus Bulking Agent for the Treatment of Post Vulvectomy Urinary Incontinence

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparison Between Tension-free Vaginal Tape and Bulking Agent for the Treatment of Post-vulvectomy Urinary Incontinence: a Randomized Controlled Trial

Conditions
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Urinary Incontinence, Stress

Intervention / Treatment
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* Procedure: Tension free vaginal tape
* Procedure: Bulking agent injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tension free vaginal tape<br> | Procedure: Tension free vaginal tape<br>* Small incision sites in the vagina and suprapubically. Bilateral retropubic insertion of the sling by means of needles<br>|
| Experimental: Bulking agent injection<br> | Procedure: Bulking agent injection<br>* Three Periurethral injections of Bulkamid ® (Ethicon,Somerville, NJ, USA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Satisfaction |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bulking agent, emivulvectomy, radical vulvectomy, TVT, urinary incontinence, vulvar cancer