Tridimensional Pelvic Floor Ultrasound and Quality of Life Scores Questionnaires in Nulliparous or Parous Women

NCT03656601 | Completed DMC

• 1 other identifier: 66574316.4.0000.5505
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Incontinence; Anal Incontinence; Sexual Dysfunction; Self Esteem; Delivery

Keywords

3D ultrasound; pelvic floor; delivery; quality of life

Outcome Measures

Primary Outcomes (1)

• 3D US pelvic floor evaluation of transverse diameter of vagina

  Evaluation of transverse diameter of vagina, in cm, by 3D pelvic floor ultrasound

  One day

Secondary Outcomes (5)

• 3D US pelvic floor evaluation of thickness of pubovisceral muscle

  One day

• 3D US pelvic floor evaluation of Hiatal area

  One day

• Impact of the delivery in quality of life - regarding urinary incontinence

  One day

• Impact of the delivery in quality of life - regarding sexual life

  One day

• Impact of the delivery in quality of life - regarding anal incontinente

  One day

Study Arms (3)

Vaginal delivery

Women that had only vaginal delivery

Diagnostic Test: 3D pelvic ultrasound

Cesarean-section

Women that had only cesarean-section

Diagnostic Test: 3D pelvic ultrasound

Nulliparous

Women without delivery

Diagnostic Test: 3D pelvic ultrasound

Interventions

3D pelvic ultrasound DIAGNOSTIC_TEST

3D pelvic ultrasound by transperineal route

Cesarean-section; Nulliparous; Vaginal delivery

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• age between 18 and 50
• reproductive age

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Service of Family Planning ang Urogynecology Service of Department of Gynecology of FEDERAL UNIVERSITY OF SAO PAULO - UNIFESP

São Paulo, São Paulo, 0-4023- 062, Brazil

Location

MeSH Terms

Conditions

Urinary Incontinence; Encopresis; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Genital Diseases

Study Officials

• Ana Maria HM Bianchi-Ferraro, PhD

  Federal University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD of Gynecology Department

Study Record Dates

• First Submitted: December 24, 2017
• First Posted: September 4, 2018
• Study Start: May 5, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

BR (1)