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

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Procedure: Tension free vaginal tape Procedure: Bulking agent injection Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : September 2012
Actual Study Completion Date : April 2013

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Cure rate [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Intra-operative complication rate [ Time Frame: 1 day ]
  2. Postoperative complication rate [ Time Frame: 12 months ]
  3. Recurrence rate [ Time Frame: 12 months ]
  4. Second surgery for stress urinary incontinence (SUI) [ Time Frame: 12 months ]
  5. Quality of life [ Time Frame: 12 months ]
  6. Satisfaction [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01148290

Pugliese Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
University Magna Graecia

Responsible Party: Stefano Palomba, Associate Professor, University Magna Graecia Identifier: NCT01148290     History of Changes
Other Study ID Numbers: 03/2010
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013

Keywords provided by Stefano Palomba, University Magna Graecia:
bulking agent
radical vulvectomy
urinary incontinence
vulvar cancer

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders