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

NCT ID: NCT02406638

Last Updated: 2015-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 158 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-03-31

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.

Conditions

Urinary Incontinence; Postoperative Period

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

TVT Group

Women who underwent to stress urinary incontinence surgery using Gynecare TVT 3 years before clinical and 3D pelvic floor ultrasound evaluation.

3D pelvic floor ultrasound

Intervention Type: OTHER

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.

3D pelvic floor ultrasound

Intervention Type: OTHER

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.

3D pelvic floor ultrasound

Intervention Type: OTHER

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

Interventions

3D pelvic floor ultrasound

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ana Maria Homem de Mello Bianchi

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudinei A Rodrigues, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Zsuzsanna IK Jármy-di-Bella, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Ana Maria HM Bianchi-Ferraro, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Locations

Federal University of Sao Paulo - Unifesp

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CAAE12805313800005505

Identifier Type: -

Identifier Source: org_study_id