Skip to main content
OpenTrials
Completed

NCT Number: NCT02406638

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

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, .

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D pelvic floor ultrasound

Other

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

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)

    Time frame: evaluation will occur in 1 day, 3 years after surgery

    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

Secondary outcomes

  1. Correlation between the suburethral tape spatial positon and objective cure rate

    Time frame: evaluation will occur in 1 day, 3 years after surgery

    Correlation between the tape spatial position measured by 3D USG and objective cure rates, accessed by stress test and pad-test

  2. Correlation between the suburethral tape spatial positon and subjective cure rate

    Time frame: evaluation will occur in 1 day, 3 years after surgery

    Correlation between the tape spatial position measured by 3D USG and subjective cure, accessed by scale of symptoms of King's Health Questionnaire

  3. Correlation between the suburethral tape spatial positon and urge-symptoms

    Time frame: evaluation will occur in 1 day, 3 years after surgery

    Correlation between the tape spatial position measured by 3D USG and urge-symptoms, accessed by scale of symptoms of King's Health Questionnaire

  4. 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)

    Time frame: evaluation will occur in 1 day, 3 years after surgery

    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.

  5. 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)

    Time frame: evaluation will occur in 1 day, 3 years after surgery

    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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Apr 2, 2015
Registry last updated
Apr 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.