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

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ClinicalTrials.gov Identifier: NCT02406638
Recruitment Status : Completed
First Posted : April 2, 2015
Last Update Posted : April 2, 2015
Sponsor:
Information provided by (Responsible Party):
Ana Maria Homem de Mello Bianchi, Federal University of São Paulo

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, .


Condition or disease Intervention/treatment
Urinary Incontinence Postoperative Period 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.


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Study Type : Observational
Actual Enrollment : 158 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Pelvic Floor 3D Ultrasound of Women Who Underwent TVT-R, TVT-O, TVT-S Surgery at Three Years Follow-up
Study Start Date : April 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406638


Locations
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Brazil
Federal University of Sao Paulo - Unifesp
São Paulo, SP, Brazil, 0-4023- 062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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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 Director: Ana Maria HM Bianchi-Ferraro, PhD Federal University of São Paulo

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Responsible Party: Ana Maria Homem de Mello Bianchi, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02406638     History of Changes
Other Study ID Numbers: CAAE12805313800005505
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: April 2, 2015
Last Verified: March 2015

Keywords provided by Ana Maria Homem de Mello Bianchi, Federal University of São Paulo:
3D Pelvic floor USG
Mid-Urethral Sling
TVT
TVT-O
TVT-S

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders