Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence (SECURiTy)

NeuroTherapia, Inc.

Status and phase: Completed; Phase 3

Conditions: Stress Urinary Incontinence

Treatments: Device: tension-free vaginal tape; Device: TVT-SECUR device

Study type: Interventional

Funder types: Other

Identifiers

NCT00534365

FFHA 07-01

Details and patient eligibility

About

The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary incontinence.

Enrollment: 281 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Urinary incontinence symptoms
• Urodynamic stress incontinence confirmed with multichannel urodynamic testing
• Age of at least 21 years
• Desires surgical correction of stress urinary incontinence

Exclusion criteria

• Post-void residual volume >100cc
• Detrusor overactivity on preoperative multichannel urodynamic testing
• History of previous synthetic, biologic or fascial sub-urethral sling
• Desires future childbearing
• History of bleeding diathesis or current anti-coagulation therapy
• Current genitourinary fistula or urethral diverticulum
• Reversible cause of incontinence (i.e. drug effect)
• Contraindication to surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

281 participants in 2 patient groups

1

Active Comparator group

Description:

Tension-free vaginal tape procedure (TVT)

Treatment:

Device: tension-free vaginal tape

2

Active Comparator group

Description:

TVT-SECUR device

Treatment:

Device: TVT-SECUR device