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CompletedNCT01094353suiUpdated Jun 21, 2017

A Comparative Study Minisling Versus Transobturator (TOT)Sling

A Phase 4 interventional study of Mini-sling and Transobturator in Female Stress Urinary Incontinence, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-21.

Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jun 2008, registered Mar 2010).
Phase
Phase 4
Study type
Interventional
Enrollment
145
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
Female
01

Study summary

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

Read the detailed description

eligibility criteria was : female stress urinary incontinence

02

Conditions studied

  • Female Stress Urinary Incontinence

Keywords

  • Urodynamic Stress urinary incontinence
  • Minisling
  • Ophira™
  • Unitape™
03

In context

Lead sponsor

Federal University of São Paulo is the lead sponsor of 438 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
145 participants (actual)

Study arms

  • 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

  • Active comparator
    Transobturator

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

    Procedure: Transobturator

Interventions

  • ProcedureMini-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.

    Also known as: Mini-sling Ophira™

  • ProcedureTransobturator

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

    Also known as: Transobturator Sling Unitape™

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: one year

07

Study locations

1 site
  • Federal University of São Paulo
    São Paulo, Brazil
08

References and documents

Publications

  • 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. PubMed 20204323 ↗
  • 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. PubMed 24499750 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01094353
Responsible party
Ana Livia Garcia Pascom (M.D., Federal University of São Paulo) — Principal investigator
First posted
Mar 26, 2010
Start date
Jun 2008
Primary completion
Dec 2011
Completion
Jul 2015
Last update
Jun 21, 2017

Study contacts

Ana LG Pascom, Pg
principal investigator · Federal University of São Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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