Clinical trial NCT02406638: Pelvic Floor 3D USG Three Years After Mid-urethral Slings ( TVT-R, TVT-O, TVT-S)
Official title: Pelvic Floor 3D Ultrasound of Women Who Underwent TVT-R, TVT-O, TVT-S Surgery at Three Years Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Postoperative Period
Keywords: 3D Pelvic floor USG
Mid-Urethral Sling
TVT
TVT-O
TVT-S
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

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, .

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.

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: evaluation will occur in 1 day, 3 years after surgery
Secondary outcomes:
measure: Correlation between the suburethral tape spatial positon and objective cure rate
timeFrame: evaluation will occur in 1 day, 3 years after surgery
measure: Correlation between the suburethral tape spatial positon and subjective cure rate
timeFrame: evaluation will occur in 1 day, 3 years after surgery
measure: Correlation between the suburethral tape spatial positon and urge-symptoms
timeFrame: evaluation will occur in 1 day, 3 years after surgery
measure: 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)
timeFrame: evaluation will occur in 1 day, 3 years after surgery
measure: 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)
timeFrame: evaluation will occur in 1 day, 3 years after surgery
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of Sao Paulo - Unifesp
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Claudinei A Rodrigues, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Zsuzsanna IK Jármy-di-Bella, PhD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Ana Maria HM Bianchi-Ferraro, PhD
role: STUDY_DIRECTOR
References: