A Comparative Study Minisling Versus Transobturator (TOT)Sling

NCT01094353 | Completed Phase 4 DMC

• 1 other identifier: ophira
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Female Stress Urinary Incontinence

Keywords

Urodynamic Stress urinary incontinence; Minisling; Ophira™; Unitape™

Outcome Measures

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

  one year

Study Arms (2)

Mini-sling

ACTIVE COMPARATOR

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

Transobturator

ACTIVE COMPARATOR

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

Procedure: Transobturator

Interventions

Mini-sling PROCEDURE

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™

Mini-sling

Transobturator PROCEDURE

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™

Transobturator

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, Brazil

Location

Related Publications (2)

• 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.

  PMID: 20204323 RESULT

• 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.

  PMID: 24499750 DERIVED

MeSH Terms

Interventions

Suburethral Slings

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Ana LG Pascom, Pg

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 26, 2010
• Study Start: June 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: July 1, 2015
• Last Updated: June 21, 2017

Record last verified: 2017-06

Locations

BR (1)