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

Stress Urinary Incontinence Clinical Trial

— SECURiTy  

Official title:

A Randomized Trial Comparing Tension-free Vaginal Tape (TVT) to the TVT-SECUR for the Surgical Treatment of Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534365
• Other study ID #: FFHA 07-01
• Status: Completed
• Phase: Phase 3
• First received: September 20, 2007
• Last updated: August 27, 2013
• Start date: August 2007
• Est. completion date: April 2011

Study information

• Verified date: August 2013
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• tension-free vaginal tape
Retropubic mid-urethral sling
• TVT-SECUR device
Mid-urethral mini-sling

Locations

Country	Name	City	State
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Main Line Health	Paoli	Pennsylvania
United States	Women & Infants Hospital of Rhode Island	Providence	Rhode Island
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (8)

Lead Sponsor	Collaborator
The Cleveland Clinic	Duke University, Foundation for Female Health Awareness, Good Samaritan Hospital, Ohio, Greater Baltimore Medical Center, Baltimore MD, Main Line Health, Washington Hospital Center, Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

References & Publications (1)

Barber MD, Weidner AC, Sokol AI, Amundsen CL, Jelovsek JE, Karram MM, Ellerkmann M, Rardin CR, Iglesia CB, Toglia M; Foundation for Female Health Awareness Research Network. Single-incision mini-sling compared with tension-free vaginal tape for the treatm — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the subjective cure of urinary incontinence at 12 months after surgery		12 months	No
Secondary	Complications		6 week, 6 month, 1 year, 2 years	Yes
Secondary	Objective Cure of stress incontinence (standing stress test)		12 months	No
Secondary	Postoperative pain		2 weeks, 6 weeks	No
Secondary	HRQOL		6 months, 12 months, 18 months, 24 months	No
Secondary	Irritative voiding symptoms & urinary retention		6 ,12, 24 months	Yes

External Links

•   Foundation for Female Health Awareness