Tension-free Vaginal Tape (TVT) Versus Bulking Agent for the Treatment of Post Vulvectomy Urinary Incontinence
|ClinicalTrials.gov Identifier: NCT01148290|
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : April 8, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence, Stress||Procedure: Tension free vaginal tape Procedure: Bulking agent injection||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2009|
|Primary Completion Date :||September 2012|
|Study Completion Date :||April 2013|
|Active Comparator: Tension free vaginal tape||
Procedure: Tension free vaginal tape
Small incision sites in the vagina and suprapubically. Bilateral retropubic insertion of the sling by means of needles
|Experimental: Bulking agent injection||
Procedure: Bulking agent injection
Three Periurethral injections of Bulkamid ® (Ethicon,Somerville, NJ, USA)
- Cure rate [ Time Frame: 12 months ]
- Intra-operative complication rate [ Time Frame: 1 day ]
- Postoperative complication rate [ Time Frame: 12 months ]
- Recurrence rate [ Time Frame: 12 months ]
- Second surgery for stress urinary incontinence (SUI) [ Time Frame: 12 months ]
- Quality of life [ Time Frame: 12 months ]
- Satisfaction [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148290
|Catanzaro, Italy, 88100|