Clinical trial NCT03656601: Tridimensional Pelvic Floor Ultrasound and Quality of Life Scores Questionnaires in Nulliparous or Parous Women
Official title: Correlation Between Tridimensional Pelvic Floor Ultrasound and Quality of Life Scores Questionnaires in Nulliparous or Parous Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Anal Incontinence
Sexual Dysfunction
Self Esteem
Delivery
Keywords: 3D ultrasound
pelvic floor
delivery
quality of life
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Reproductive age women, followed in Family Planning Service and Urogynecology Service of Federal of São Paulo University recruited from May 2016 to June 2018.

Brief summary: Evaluation of the impact of the delivery in the system of suspension and sustentation of pelvic floor, by 3D ultrasound and quality of life questionnaires.nt

Detailed description: The pelvic floor is a complex group of muscle, fascia and connective tissue that recover the basis of the pelvic bones, forming the system of suspension and sustentation of the pelvic organs. Different events that happen during the life of women, like pregnancy, delivery, gain of weight and hormonal alterations from the menopause, may affects the strength of the muscles and of other structures that supports pelvic organs. The importance of the balance of the pelvic organs in maintenance of quality of life have been recognized in literature last years. Different studies established association between sexual disfunction and emotional dissatisfaction, as well as reduction of well-being in that women. The urinary incontinence and anal incontinence are also important factors that compromised quality of life and can provoke harmful effects over the self-esteem of women and diminish relationship. The 3D ultrasound (3D UD) is a non-invasive method, reproductible, and technically easy of evaluate the pelvic floor. Different routes may be used, but the transperineal is the most common. By this route is possible to evaluate the pelvic floor anatomy, as well as its disfunction into deep planes, what we can not afford only with the physical exam.

The objective was to evaluate the impact of the delivery on the pelvic floor, by the 3D ultrasound evaluation and to correlate it with the scores of sexual questionnaire (FSFI), urinary questionnaire (King´s) and anal incontinence questionnaire ( specific questions about loss of gases).

This is a transversal study of a cohort of women in reproductive age recruited from May 2016 to June 2018. The clinical and US evaluation were performed at the same medical visit. Patients signed the consent term and answered the questionnaires (King's health quality of life questionnaire, FSF-I (Female Sexual Function - Index, and a scale of anal incontinence) before the ultrasonographic exams. The USG evaluation was performed using GE Voluson 730 expert systems with RAB 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. The volumes datasets were analyzed offline by of the authors. They were blinded and the average values were considered.

The studied parameters was the hiatal area (HA), the antero-posterior diameter (PA), transverse diameter (TD) and the muscle thickness (MT). The measures were obtained by the OmniView VCI mode.

Statistical analysis was performed using student t, ANOVA and Tukey. P value of \<0.05 was considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 50
* reproductive age

Exclusion Criteria:

* bad quality of 3D US images
* post- menopause
* vulvovaginitis
* urinary incontinence
* Human papillomavirus vulvar disease (condyloma acuminata)
* previous pelvic floor surgery

Primary outcomes:
measure: 3D US pelvic floor evaluation of transverse diameter of vagina
timeFrame: One day
Secondary outcomes:
measure: 3D US pelvic floor evaluation of thickness of pubovisceral muscle
timeFrame: One day
measure: 3D US pelvic floor evaluation of Hiatal area
timeFrame: One day
measure: Impact of the delivery in quality of life - regarding urinary incontinence
timeFrame: One day
measure: Impact of the delivery in quality of life - regarding sexual life
timeFrame: One day
measure: Impact of the delivery in quality of life - regarding anal incontinente
timeFrame: One day
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Service of Family Planning ang Urogynecology Service of Department of Gynecology of FEDERAL UNIVERSITY OF SAO PAULO - UNIFESP
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Ana Maria HM Bianchi-Ferraro, PhD
role: STUDY_DIRECTOR
References: