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

Urinary Incontinence, Stress Clinical Trial

Official title:

A Comparison Between Tension-free Vaginal Tape and Bulking Agent for the Treatment of Post-vulvectomy Urinary Incontinence: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148290
• Other study ID #: 03/2010
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2010
• Last updated: April 5, 2013
• Start date: May 2009
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• Tension free vaginal tape
Small incision sites in the vagina and suprapubically. Bilateral retropubic insertion of the sling by means of needles
• Bulking agent injection
Three Periurethral injections of Bulkamid ® (Ethicon,Somerville, NJ, USA)

Locations

Country	Name	City	State
Italy	Pugliese Hospital	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate		12 months	No
Secondary	Intra-operative complication rate		1 day	Yes
Secondary	Postoperative complication rate		12 months	Yes
Secondary	Recurrence rate		12 months	No
Secondary	Second surgery for stress urinary incontinence (SUI)		12 months	No
Secondary	Quality of life		12 months	No
Secondary	Satisfaction		12 months	No