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NCT01095159 Clinical Trial

TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

— TVTOxTVTS  

Official title:
Comparative Study of TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01095159
Other study ID # UNIFESP-TVTOxTVTS
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 2009
Est. completion date December 2013

Study information
Verified date May 2018
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of TVTO™ and TVTSecur™ as surgical treatment for female urinary stress incontinence.

Recruitment information / eligibility
Status Completed
Enrollment 124
Est. completion date December 2013
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Clinical and urodynamic for stress urinary

Exclusion Criteria:

- Detrusor overactivity (urodynamic study)

- Urodynamic changes suggesting reduced vesical capacity

- Associated neurological diseases

- Coagulopathies

- Pregnancy

- Foreign matter sensitiveness history

- Acute urinary tract infection

- Sequel from high ionizing radiation exposure

- Use of drugs that may result in high surgical risk and/or significant postoperative complication

- Anesthetic procedure contraindication

- Vulvovaginitis: presence of vaginal secretion with infection clinically or lab supported

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TVT-O
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).
• TVT-S
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).

Locations
Country Name City State
Brazil Federal University of Sao Paulo - Unifesp São Paulo SP

Sponsors (2)
Lead Sponsor Collaborator
Federal University of São Paulo Johnson & Johnson

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare the efficacy of employing the Gynecare TVT Secur™ with the traditional Gynecare TVT- O™ for treating female stress urinary incontinence. 1 year
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Completed NCT01123096 - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence? N/A
Completed NCT01770691 - Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence N/A
Completed NCT00234754 - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women N/A
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Completed NCT03985345 - Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence. N/A
Active, not recruiting NCT03671694 - Laser Vaginal Treatment for SUI N/A
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