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

NCT ID: NCT01148290

Last Updated: 2013-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-04-30

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.

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.

Conditions

Urinary Incontinence, Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tension free vaginal tape

Group Type: ACTIVE_COMPARATOR

Tension free vaginal tape

Intervention Type: PROCEDURE

Small incision sites in the vagina and suprapubically. Bilateral retropubic insertion of the sling by means of needles

Bulking agent injection

Group Type: EXPERIMENTAL

Bulking agent injection

Intervention Type: PROCEDURE

Three Periurethral injections of Bulkamid ® (Ethicon,Somerville, NJ, USA)

Interventions

Tension free vaginal tape

Small incision sites in the vagina and suprapubically. Bilateral retropubic insertion of the sling by means of needles

Intervention Type: PROCEDURE

Bulking agent injection

Three Periurethral injections of Bulkamid ® (Ethicon,Somerville, NJ, USA)

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Stefano Palomba

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pugliese Hospital

Catanzaro, , Italy

Countries

Italy

Other Identifiers

03/2010

Identifier Type: -

Identifier Source: org_study_id