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

Phase 3

Completed

• Conditions: Urinary Incontinence, Stress
• Interventions: Procedure: Tension free vaginal tape; Procedure: Bulking agent injection

• Registration Number: NCT01148290
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Primary Completion: 2012-09
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-05
• Last Update Posted: 2013-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tension free vaginal tape	Tension free vaginal tape	-
Bulking agent injection	Bulking agent injection	-

Primary Outcome Measures

Name	Time	Method
Cure rate	12 months

Secondary Outcome Measures

Name	Time	Method
Satisfaction	12 months
Intra-operative complication rate	1 day
Postoperative complication rate	12 months
Recurrence rate	12 months
Second surgery for stress urinary incontinence (SUI)	12 months
Quality of life	12 months

Trial Locations

Locations (1)

Pugliese Hospital; 🇮🇹 Catanzaro, Italy