Clinical trial NCT01148290: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence, Stress
Keywords: bulking agent
emivulvectomy
radical vulvectomy
TVT
urinary incontinence
vulvar cancer
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cure rate
timeFrame: 12 months
Secondary outcomes:
measure: Intra-operative complication rate
timeFrame: 1 day
measure: Postoperative complication rate
timeFrame: 12 months
measure: Recurrence rate
timeFrame: 12 months
measure: Second surgery for stress urinary incontinence (SUI)
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Pugliese Hospital
Study officials:
References: