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

Primary Purpose

Female Stress Urinary Incontinence

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Mini-sling
Transobturator
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Stress Urinary Incontinence focused on measuring Urodynamic Stress urinary incontinence, Minisling, Ophira™, Unitape™

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mini-sling

Transobturator

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 24, 2010
Last Updated
June 19, 2017
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01094353
Brief Title
A Comparative Study Minisling Versus Transobturator (TOT)Sling
Acronym
sui
Official Title
Randomised Trial of Ophira™ Minisling System and Unitape™ for the Treatment of Stress Urinary Incontinence in Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (Actual)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot with minisling.
Detailed Description
eligibility criteria was : female stress urinary incontinence

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Stress Urinary Incontinence
Keywords
Urodynamic Stress urinary incontinence, Minisling, Ophira™, Unitape™

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mini-sling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Transobturator
Arm Type
Active Comparator
Arm Description
Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence
Intervention Type
Procedure
Intervention Name(s)
Mini-sling
Other Intervention Name(s)
Mini-sling Ophira™
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transobturator
Other Intervention Name(s)
Transobturator Sling Unitape™
Intervention Description
Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence
Primary Outcome Measure Information:
Title
to assess efficacy between tot with minisling in cure in women with stress urinary incontinence
Description
to assess efficacy and safety of minisling and transobturator sling in treatment of female stress urinary incontinence
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana LG Pascom, Pg
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
20204323
Citation
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. Epub 2010 Mar 4.
Results Reference
result
PubMed Identifier
24499750
Citation
Djehdian LM, Araujo MP, Takano CC, Del-Roy CA, Sartori MGF, Girao MJBC, Castro RA. Transobturator sling compared with single-incision mini-sling for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2014 Mar;123(3):553-561. doi: 10.1097/AOG.0000000000000148.
Results Reference
derived

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A Comparative Study Minisling Versus Transobturator (TOT)Sling

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