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

Pelvic Floor 3D Ultrasound of Women Who Underwent TVT-R, TVT-O, TVT-S Surgery at Three Years Follow-up

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, .

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Postoperative Period
• Intervention / Treatment: Other: 3D pelvic floor ultrasound

Detailed Description

Introduction: The three dimensional ultrasonography (3D USG) provides a clear spatial orientation of polypropylene tape and can help clarify the pathogenesis of bladder dysfunction after a TVT procedure. Thus, the USG in urogynecology postoperative has shown an increasing role in monitoring surgically treated patients and specially in complications such as urinary retention and urinary disorders.

Objective: 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 of women surgically treated for stress urinary incontinence by retropubic sling (TVT-R), transobturator sling (TVT-O) or single-incision sling (TVT-S). The surgeries occurred from May 2009 to December 2011. Were eligible for the study 158 patients. The clinical and USG evaluation were performed at the same medical visit, from April 2013 to June 2014, after local ethics committee approval and signature of informed consent. The objective cure rates were evaluated by negative pad-test and stress test. The subjective cure rate and urgency symptoms were accessed by questionnaires. The subjective cure was defined as absence of reports of stress urinary leakage.

The USG evaluation was performed using General Electric Voluson 730 expert systems with 8 - 4 Mhz volume transducers with an 85-degree acquisition angle. The exams were performed with patient in supine position with hip flexed and using slightly abduced, after voiding. The US transducer was placed on the perineum in the midsagittal position and volumes were obtained at rest, at maximum Valsalva, and perineal contraction. Moved mode rendering for OMNINI View plan as previous described.The volumes datasets were analyzed offline by of the authors. They were blinded and the average values were considered.

The urethral length and the location of the sling, measured by the distance between bladder neck and the tape (CF), were assessed in midsagittal plane. The tape angle in relation to the urethra were assessed in OMINI VIEW plan.

Statistical analysis was performed using student t, ANOVA and Tukey-test. P value of <0.05 was considered statistically significant.

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 0-4023- 062
      • Federal University of Sao Paulo - Unifesp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Pelvic Floor 3D Ultrasound Clinical evaluation with pad-test, stress test and questionnaires of symptoms and quality of life
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; Pelvic Floor 3D Ultrasound Clinical evaluation with pad-test, stress test and questionnaires of symptoms and quality of life
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; Pelvic Floor 3D Ultrasound Clinical evaluation with pad-test, stress test and questionnaires of symptoms and quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the suburethral tape spatial positon and objective cure rate	Correlation between the tape spatial position measured by 3D USG and objective cure rates, accessed by stress test and pad-test	evaluation will occur in 1 day, 3 years after surgery
Correlation between the suburethral tape spatial positon and subjective cure rate	Correlation between the tape spatial position measured by 3D USG and subjective cure, accessed by scale of symptoms of King's Health Questionnaire	evaluation will occur in 1 day, 3 years after surgery
Correlation between the suburethral tape spatial positon and urge-symptoms	Correlation between the tape spatial position measured by 3D USG and urge-symptoms, accessed by scale of symptoms of King's Health Questionnaire	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)	Measured of the distance between the tape and vesical neck, in mm, of 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
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)	Relation between the measured of urethral length (mm) and the distance between the tape and vesical neck( in mm), measured by 3D USG at rest Valsalva and pelvic floor contraction of the three different suburethral tapes, in order to determine if they remain in the midurethra.	evaluation will occur in 1 day, 3 years after surgery

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Claudinei A Rodrigues, MD, Federal University of São Paulo; Study Chair: Zsuzsanna IK Jármy-di-Bella, PhD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: April 1, 2015
• First Posted (ESTIMATE): April 2, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): April 2, 2015
• Last Update Submitted That Met QC Criteria: April 1, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: TVT-O; TVT; 3D Pelvic floor USG; Mid-Urethral Sling; TVT-S
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence
• Other Study ID Numbers: CAAE12805313800005505