Urinary Incontinence, Stress
Conditions
Keywords
bulking agent, emivulvectomy, radical vulvectomy, TVT, urinary incontinence, vulvar cancer
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.
Interventions
PROCEDURETension free vaginal tape
Small incision sites in the vagina and suprapubically. Bilateral retropubic insertion of the sling by means of needles
PROCEDUREBulking agent injection
Three Periurethral injections of Bulkamid ® (Ethicon,Somerville, NJ, USA)
Sponsors
University Magna Graecia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Intra-operative complication rate | 1 day |
| Postoperative complication rate | 12 months |
| Quality of life | 12 months |
| Second surgery for stress urinary incontinence (SUI) | 12 months |
| Satisfaction | 12 months |
| Recurrence rate | 12 months |
Countries
Italy
Outcome results
None listed