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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stefano Palomba, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT01148290
First received: June 21, 2010
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Urinary Incontinence, Stress
 Procedure: Tension free vaginal tape
Procedure: Bulking agent injection
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Cure rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intra-operative complication rate [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • Postoperative complication rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Recurrence rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Second surgery for stress urinary incontinence (SUI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2009
Study Completion Date: April 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148290

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

No publications provided

Responsible Party: Stefano Palomba, Associate Professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT01148290     History of Changes
Other Study ID Numbers: 03/2010
Study First Received: June 21, 2010
Last Updated: April 5, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University Magna Graecia:
bulking agent
emivulvectomy
radical vulvectomy
 TVT
urinary incontinence
vulvar cancer

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013