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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406638
• Other study ID #: CAAE12805313800005505
• Status: Completed
• Phase: N/A
• First received: March 25, 2015
• Last updated: April 1, 2015
• Start date: April 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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, .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: March 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Postoperative Period
• Urinary Incontinence

Intervention

Other:
• 3D pelvic floor ultrasound
Pelvic Floor 3D Ultrasound Clinical evaluation with pad-test, stress test and questionnaires of symptoms and quality of life

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo - Unifesp	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes