A Comparative Study Minisling Versus Transobturator (TOT)Sling

Female Stress Urinary Incontinence Clinical Trial

— sui  

Official title:

Randomised Trial of Ophira™ Minisling System and Unitape™ for the Treatment of Stress Urinary Incontinence in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094353
• Other study ID #: ophira
• Status: Completed
• Phase: Phase 4
• First received: March 24, 2010
• Last updated: June 19, 2017
• Start date: June 2008
• Est. completion date: July 2015

Study information

• Verified date: June 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot with minisling.

Description:

eligibility criteria was : female stress urinary incontinence

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: July 2015
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• clinical and urodynamic diagnosis of SUI in patients between 18 and 90 years

Exclusion Criteria:

• postvoid residual urine volume more than 100 ml, coagulation disorders, current urinary tract infection, sequelae of previous radiation therapy of the pelvis, anticoagulant therapy, vulvovaginitis, and anesthesia contraindication

Related Conditions & MeSH terms

• Enuresis
• Female Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• Mini-sling
The minisling is a new intervention therapeutic option for surgical treatment in women with stress urinary incontinence. It is made of polypropylene monofilament mesh, held between two self-anchoring polypropylene columns in a fishbone design connected to two delivering needles.
• Transobturator
Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

De Ridder D, Berkers J, Deprest J, Verguts J, Ost D, Hamid D, Van der Aa F. Single incision mini-sling versus a transobutaror sling: a comparative study on MiniArc and Monarc slings. Int Urogynecol J. 2010 Jul;21(7):773-8. doi: 10.1007/s00192-010-1127-z. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to assess efficacy between tot with minisling in cure in women with stress urinary incontinence	to assess efficacy and safety of minisling and transobturator sling in treatment of female stress urinary incontinence	one year