Urinary IncontinenceNCT03656601
Tridimensional Pelvic Floor Ultrasound and Quality of Life Scores Questionnaires in Nulliparous or Parous Women
An observational study of Urinary Incontinence and Anal Incontinence, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Anal Incontinence, Sexual Dysfunction
- What is being tested?
- 3D pelvic ultrasound
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 5 May 2016to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- age between 18 and 50
- reproductive age
Who cannot join
- bad quality of 3D US images
- post- menopause
- vulvovaginitis
- urinary incontinence
- Human papillomavirus vulvar disease (condyloma acuminata)
- previous pelvic floor surgery
Trial locations and contacts
1 site in 1 country.
Brazil1 site
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
About this study
Official title: Correlation Between Tridimensional Pelvic Floor Ultrasound and Quality of Life Scores Questionnaires in Nulliparous or Parous Women
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
Read the 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.
- Being tested
- 3D pelvic ultrasound
- Keywords
- 3D ultrasound, pelvic floor, delivery, quality of life
- Medical subject headings
- Urinary Incontinence, Encopresis, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D pelvic ultrasoundDiagnostic test
3D pelvic ultrasound by transperineal route
| Study group | Role | What they receive |
|---|---|---|
| Vaginal delivery | Women that had only vaginal delivery Receives: Diagnostic Test: 3D pelvic ultrasound | |
| Cesarean-section | Women that had only cesarean-section Receives: Diagnostic Test: 3D pelvic ultrasound | |
| Nulliparous | Women without delivery Receives: Diagnostic Test: 3D pelvic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D US pelvic floor evaluation of transverse diameter of vagina
Evaluation of transverse diameter of vagina, in cm, by 3D pelvic floor ultrasound
Measured: One day
Secondary outcomes (5)
3D US pelvic floor evaluation of thickness of pubovisceral muscle
Evaluation of thickness of pubovisceral muscle, in cm , by 3D pelvic floor ultrasound
Measured: One day
3D US pelvic floor evaluation of Hiatal area
Evaluation of Hiatal area in cm3, with measures made by 3D pelvic floor ultrasound
Measured: One day
Impact of the delivery in quality of life - regarding urinary incontinence
Evaluation of the impact of delivery in women's quality of life measured by the King's Health Questionnaire score. ( Score range from 0-100, bigger values are associated with worse quality of life)
Measured: One day
Impact of the delivery in quality of life - regarding sexual life
Evaluation of the impact of delivery in women's quality of life measured by FSF-I score ( Score range from 4-99, considered normal over 26)
Measured: One day
Impact of the delivery in quality of life - regarding anal incontinente
Evaluation of the impact of delivery in women's quality of life measured by the score of anal incontinence scale (ocorre range from 0-12, bigger values are associated with worse quality of life)
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start5 May 2016
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Maria Homem de Mello Bianchi, Federal University of São Paulo
- Investigators
- Ana Maria HM Bianchi-Ferraro, PhD, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656601
- Sponsor's protocol ID
- 66574316.4.0000.5505
- Status last verified
- Sep 2023
- First submitted
- 24 Dec 2017
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Tridimensional Pelvic Floor Ultrasound and Quality of Life Scores Questionnaires in Nulliparous or Parous Women
- ClinicalTrials.gov ID
- NCT03656601
- Acronym / sponsor ID
- 66574316.4.0000.5505
- Keywords
- 3D ultrasound, pelvic floor, delivery, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 5 May 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaginal delivery | – | Diagnostic Test: 3D pelvic ultrasoundWomen that had only vaginal delivery |
| Cesarean-section | – | Diagnostic Test: 3D pelvic ultrasoundWomen that had only cesarean-section |
| Nulliparous | – | Diagnostic Test: 3D pelvic ultrasoundWomen without delivery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- age between 18 and 50
- reproductive age
Key exclusion criteria (6 listed)
- bad quality of 3D US images
- post- menopause
- vulvovaginitis
- urinary incontinence
- Human papillomavirus vulvar disease (condyloma acuminata)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D pelvic ultrasound3D pelvic ultrasound by transperineal route | Diagnostic test | Cesarean-section, Nulliparous, Vaginal delivery |
Primary outcome
3D US pelvic floor evaluation of transverse diameter of vagina
Time frame: One day
Evaluation of transverse diameter of vagina, in cm, by 3D pelvic floor ultrasound
5 secondary outcomes
3D US pelvic floor evaluation of thickness of pubovisceral muscle
Time frame: One day
3D US pelvic floor evaluation of Hiatal area
Time frame: One day
Impact of the delivery in quality of life - regarding urinary incontinence
Time frame: One day
Impact of the delivery in quality of life - regarding sexual life
Time frame: One day
Impact of the delivery in quality of life - regarding anal incontinente
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Maria HM Bianchi-Ferraro, PhD study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Anal Incontinence, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D US pelvic floor evaluation of transverse diameter of vagina (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.