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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01148290
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : April 8, 2013
Information provided by (Responsible Party):
Stefano Palomba, University Magna Graecia

June 21, 2010
June 22, 2010
April 8, 2013
May 2009
September 2012   (Final data collection date for primary outcome measure)
Cure rate [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01148290 on Archive Site
  • 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 ]
Same as current
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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

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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Urinary Incontinence, Stress
  • Procedure: Tension free vaginal tape
    Small incision sites in the vagina and suprapubically. Bilateral retropubic insertion of the sling by means of needles
  • Procedure: Bulking agent injection
    Three Periurethral injections of Bulkamid ® (Ethicon,Somerville, NJ, USA)
  • Active Comparator: Tension free vaginal tape
    Intervention: Procedure: Tension free vaginal tape
  • Experimental: Bulking agent injection
    Intervention: Procedure: Bulking agent injection
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2013
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 95 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Stefano Palomba, University Magna Graecia
University Magna Graecia
Not Provided
Not Provided
University Magna Graecia
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP