NCT02406638

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 158 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence
• Postoperative Period

Interventions

Type	Name	Description
OTHER	3D pelvic floor ultrasound	Pelvic Floor 3D Ultrasound Clinical evaluation with pad-test, stress test and questionnaires of symptoms and quality of life

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-06-01
• Completion: 2015-03-01
• First posted: 2015-04-02
• Last updated: 2015-04-02

Locations

1 site across 1 country: Brazil