sui: A Comparative Study Minisling Versus Transobturator (TOT)Sling

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01094353

Collaborator

(none)

145

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Female Stress Urinary Incontinence	Procedure: Mini-sling Procedure: Transobturator	Phase 4

Detailed Description

eligibility criteria was : female stress urinary incontinence

Study Design

Study Type:

Interventional

Actual Enrollment :

145 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Clinical, prospective, single-center, randomized controlled trial comparing the efficacy and safety of a single-incision mini-sling and a transobturator midurethral sling for female stress urinary incontinence (SUI) treatment.Clinical, prospective, single-center, randomized controlled trial comparing the efficacy and safety of a single-incision mini-sling and a transobturator midurethral sling for female stress urinary incontinence (SUI) treatment.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

The participants were randomly allocated to a single-incision mini-sling or a transobturator midurethral tape by a simple randomization procedure using a random number generator computer program. Randomization was performed at the moment of inclusion by a nurse blinded to women's histories. Group assign- ment was concealed in consecutively numbered, sealed, opaque envelopes that were opened in the operating room just before the procedure.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mini-sling The minisling Ophira™ 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.	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. Other Names: Mini-sling Ophira™
Active Comparator: Transobturator Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence	Procedure: Transobturator Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence Other Names: Transobturator Sling Unitape™

Arm

Intervention/Treatment

Active Comparator: Mini-sling

The minisling Ophira™ 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.

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.

Other Names:

Mini-sling Ophira™

Active Comparator: Transobturator

Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence

Procedure: Transobturator

Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence

Other Names:

Transobturator Sling Unitape™

Outcome Measures

Primary Outcome Measures

to assess efficacy between tot with minisling in cure in women with stress urinary incontinence [one year]
to assess efficacy and safety of minisling and transobturator sling in treatment of female stress urinary incontinence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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