Pelvic Floor 3D USG Three Years After Mid-urethral Slings ( TVT-R, TVT-O, TVT-S)

NCT02406638 | Completed

• 1 other identifier: CAAE12805313800005505
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

Compare through 3D USG the tape spatial orientation, in three different techniques of insertion of mid-urethral synthetic sling, correlating USG findings to postoperative results in an average of three years follow-up. Methods: This is a transversal study of a cohort women surgically treated for stress urinary incontinence by retropubic sling (TVT-R), transobturator sling (TVT-O) or single-incision sling (TVT-S). The clinical and USG evaluation were performed at the same medical visit, from April 2013 to June 2014, .

Conditions

Urinary Incontinence; Postoperative Period

Keywords

3D Pelvic floor USG; Mid-Urethral Sling; TVT; TVT-O; TVT-S

Outcome Measures

Primary Outcomes (1)

• Determination of the tape spatial position ( angle between tape arms surrounding urethra measured in grades) in three different techniques of insertion of midurethral synthetic sling (TVT, TVT-O, TVT-S)

  Measured of the angle between tape arms surrounding urethra (in grades) in the three different suburethral tapes measured by 3D USG at rest Valsalva and pelvic floor contraction

  evaluation will occur in 1 day, 3 years after surgery

Secondary Outcomes (5)

• Correlation between the suburethral tape spatial positon and objective cure rate

  evaluation will occur in 1 day, 3 years after surgery

• Correlation between the suburethral tape spatial positon and subjective cure rate

  evaluation will occur in 1 day, 3 years after surgery

• Correlation between the suburethral tape spatial positon and urge-symptoms

  evaluation will occur in 1 day, 3 years after surgery

• Determination of the tape position, distance between the tape and vesical neck (measured in mm) in three different techniques of insertion of midurethral synthetic sling (TVT, TVT-O, TVT-S)

  evaluation will occur in 1 day, 3 years after surgery

• Determination of the tape position, relation between urethral length and distance between tape and vesical neck (measured in mm) in three different techniques of insertion of midurethral synthetic sling (TVT, TVT-O, TVT-S)

  evaluation will occur in 1 day, 3 years after surgery

Study Arms (3)

TVT Group

Women who underwent to stress urinary incontinence surgery using Gynecare TVT 3 years before clinical and 3D pelvic floor ultrasound evaluation.

Other: 3D pelvic floor ultrasound

TVT-O Group

Women who underwent to stress urinary incontinence surgery using Gynecare TVT Obturator System, inside-out approach, 3 years before clinical and 3D pelvic floor ultrasound evaluation.

Other: 3D pelvic floor ultrasound

TVT-S Group

Women who underwent to stress urinary incontinence surgery using GynecareTVT-Secur System, in "U" approach, 3 years before clinical and 3D pelvic floor ultrasound evaluation.

Other: 3D pelvic floor ultrasound

Interventions

3D pelvic floor ultrasound OTHER

Pelvic Floor 3D Ultrasound Clinical evaluation with pad-test, stress test and questionnaires of symptoms and quality of life

TVT Group; TVT-O Group; TVT-S Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women who underwent stress urinary incontinence surgery with synthetic midurethral sling, by different approaches ( TVT, TVT-O and TVT-Secur) in a period of 2 to 4 years before clinical and 3D USG evaluation

You may qualify if:

• Women who underwent surgical treatment for stress urinary incontinence using TVT, TVT-O and TVT-Secur, in a period of 2 to 4 years before the USG evaluation
• Informed consent signed

You may not qualify if:

• Patients who underwent to more than one surgery for urinary incontinence using polypropylene tape
• Ultrasound images that would not allow adequate visualization of the tape

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo - Unifesp

São Paulo, São Paulo, 0-4023- 062, Brazil

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudinei A Rodrigues, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Zsuzsanna IK Jármy-di-Bella, PhD

  Federal University of São Paulo

  STUDY CHAIR

• Ana Maria HM Bianchi-Ferraro, PhD

  Federal University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: April 2, 2015
• Study Start: April 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: March 1, 2015
• Last Updated: April 2, 2015

Record last verified: 2015-03

Locations

BR (1)